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Monthly Update Report for Trials Started in December 2025


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1: Summary data from new trials identified for Prostate Cancer.


Overview

Number of Trials: 22

These 22 trials focus predominantly on prostate cancer (19 trials), with additional studies in breast, colorectal, and other solid tumors. Interventions span radiation therapy optimization, novel biologics and antibody-drug conjugates, radioligand therapies (177Lu-PSMA-617), immunotherapies (sipuleucel-T, pembrolizumab), metabolic interventions (GLP-1 agonists, fasting), supportive care (oral cryotherapy, telehealth delivery), and diagnostic imaging (PSMA PET). Several trials test experimental agents targeting PSMA, B7-H3, kallikrein-2, EZH1/2, and Werner helicase. Many studies address metastatic castration-resistant prostate cancer, while others focus on localized disease, active surveillance, or treatment-related toxicity mitigation.

Common Criteria Across Trials

Common Inclusion

  • Age ≥18 years
  • Histologically confirmed adenocarcinoma of the prostate
  • ECOG performance status 0-2
  • Adequate organ function (liver, kidney, bone marrow)
  • Measurable or evaluable disease
  • Castrate testosterone levels (<50 ng/dL) for metastatic castration-resistant prostate cancer trials
  • Prior systemic therapy (for advanced disease trials)
  • Written informed consent

Common Exclusion

  • Active brain or CNS metastases (unless treated and stable)
  • Prior malignancy within 2-5 years (except non-melanoma skin cancer, in situ carcinoma)
  • Active infection requiring systemic therapy
  • Uncontrolled cardiac disease or significant cardiovascular comorbidity
  • Known HIV, hepatitis B, or hepatitis C (unless controlled/undetectable)
  • Prior treatment with the investigational agent
  • ECOG performance status >2
  • Inadequate organ function

Outcomes Summary

Primary Outcomes

Secondary Outcomes


2: Extracted Trials with New Information


Trials with Special Criteria

Genomic / Biomarker Trials

Unique or Unusual Criteria

Trials with Emerging Treatments


3: Individual Trial Overviews


NCT06200259

Reduction of Gastrointestinal Toxicity in Prostate Cancer by Proton Spot Placement

Organization/Sponsor: Thompson Cancer Survival Center


Example patient: A 62-year-old man with newly diagnosed Gleason 7 prostatic adenocarcinoma, clinical stage T2a, PSA 12 ng/mL, ECOG 0, no prior pelvic radiation or prostate treatments, and no active inflammatory bowel disease.

Phase N/A

Interventions

  • Radiation Planning: Traditional proton treatment planning system
    Summary: Computerized radiation therapy system that images tumors and creates plans to focus proton beams on targets while avoiding sensitive structures, reducing collateral damage (NCI Thesaurus).
  • Radiation Planning: Spot Delete planning for proton therapy
    Summary: Precise proton therapy using electronically guided scanning and magnets to deliver millimeter-wide beams with controlled position and depth for three-dimensional tumor targeting (NCI Thesaurus).

Key Inclusion

  • Pathological proven diagnosis of prostatic adenocarcinoma
  • Clinical stage T1-T2c
  • PSA < 20 ng/mL
  • Gleason Score ≤ 7
  • ECOG Performance status 0-1
  • Age 18 years or older

Key Exclusion

  • Prior radiotherapy to the pelvic area
  • Prior prostate cancer therapy: cryotherapy or hyperthermia
  • Prior systemic therapy (chemotherapy) for prostate cancer
  • Regional lymph nodes are a target of treatment
  • Active diverticulitis, ulcerative colitis, or Crohn's disease

NCT07218718

A Pilot Study Examining the Feasibility of Oral Cryotherapy (Popsicles) in Decreasing Dysgeusia in Patients With Prostate Cancer Receiving Single Agent Taxane Therapy

Organization/Sponsor: City of Hope Medical Center


Example patient: A 65-year-old English-speaking man with prostate cancer, ECOG performance status 1, chemotherapy-naïve, starting first-line taxane therapy without prior taste changes or oral surgery.

Phase N/A

Interventions

  • Procedure: Survey Administration
    Summary: Collection of patient responses via questionnaires to assess outcomes and symptoms (NCI Thesaurus).
  • Procedure: Oral Cryotherapy
    Summary: Cooling of the mouth using ice popsicles to reduce dysgeusia and oral toxicity associated with taxane chemotherapy (NCI Thesaurus).
  • Other: Best Practice
    Summary: Standard treatment recommendation expected to benefit the majority of patients in a specific group (NCI Thesaurus).

Key Inclusion

  • Prostate cancer diagnosis
  • Age at least 18 years
  • Undergoing initial single agent taxane chemotherapy
  • Chemotherapy naïve
  • English speaking
  • ECOG performance score less than 2
  • Willingness to suck on popsicles during chemotherapy infusion
  • Willingness to complete baseline and follow-up surveys

Key Exclusion

  • Pre-existing taste alterations
  • Previous oral surgery
  • Oral malformation
  • Receiving oxaliplatin chemotherapy

NCT06906471

A Single-Arm, Blinded, Fluorescent PSMA Histopathology Trial of AS1986NS

Organization/Sponsor: Antelope Surgical Solutions, Inc


Example patient: A 67-year-old man with elevated PSA and abnormal digital rectal exam scheduled for multi-core prostate biopsy, with normal kidney function (CrCl 75 mL/min) and no prior PSMA-targeted radiotherapy.

Phase 1, Phase 2

Interventions

  • Drug: AS1986NS
    Summary: AS1986NS is a fluorescent imaging agent targeting prostate-specific membrane antigen (PSMA) to stain prostate cancer cells, administered via intravenous injection for histopathology evaluation in Phase I/II trials (Source: Web Search).

Key Inclusion

  • Suspected prostate cancer
  • Warranting standard of care multi-core prostate biopsy

Key Exclusion

  • Receiving same-day therapeutic Lutetium-177 PSMA receptor radiation isotope therapy
  • Receiving same-day therapeutic Actinium-225 PSMA receptor radiation isotope therapy
  • Pre-existing impaired or abnormal hepatic function
  • Pre-existing impaired or abnormal renal function
  • Pre-existing impaired or abnormal cardiac function
  • Abnormal elevated temperature
  • Creatinine clearance less than 60 mL/min

NCT07285044

Cancer CARE (Connected Access and Remote Expertise) Beyond Walls - Pilot, Phase 2 Clinical Trial to Evaluate Administration of Cancer-Directed Therapy in the Patient's Homes Versus in Clinic in the Florida Panhandle and Surrounding Areas

Organization/Sponsor: Mayo Clinic


Example patient: A 62-year-old man with metastatic prostate cancer receiving pembrolizumab and leuprolide with ECOG PS 1, living in the Florida Panhandle with Wi-Fi access and stable social support, tolerating treatment well without significant adverse reactions.

Phase 2

Interventions

  • Procedure: Questionnaire Administration
    Summary: Administration of questionnaires to assess patient-reported outcomes and experiences during home-based cancer therapy delivery (NCI Thesaurus).
  • Procedure: Cancer Therapeutic Procedure
    Summary: Standard-of-care cancer interventions including immunotherapies, targeted therapies, and supportive medications administered at home versus clinic for malignant neoplasm management (NCI Thesaurus).

Key Inclusion

  • Histologically confirmed malignancy receiving eligible standard-of-care treatment regimen
  • Age >= 18 years
  • ECOG performance status 0-3
  • Adequate tolerability of current treatment without significant drug reactions
  • Resides in Florida Panhandle area serviced by at-home healthcare supplier
  • Home has Wi-Fi connection for remote monitoring
  • Plans to continue eligible treatment for >= 12 weeks
  • Social stability appropriate for home-based program

Key Exclusion

  • Co-morbid systemic illnesses making patient inappropriate for home-based care
  • Receiving investigational agent for primary neoplasm treatment
  • Requires continuous 24/7 assistance without available caregiver support
  • Current inpatient hospitalization

NCT07001241

Effects of a Telehealth Exercise Program for Rural Cancer Survivors With Cancer-related Fatigue Including Integrated Longitudinal Assessments of Objective Physical Function and Fatty Acid Oxidation

Organization/Sponsor: University of Colorado, Denver


Example patient: A 62-year-old woman living in rural Colorado with breast cancer who completed chemotherapy 18 months ago, currently on maintenance hormonal therapy, experiencing moderate fatigue, with home internet access and ECOG status 1.

Phase N/A

Interventions

  • Behavioral: Telehealth Exercise Program
    Summary: Remote health care delivery using computers and video-conferencing equipment to provide exercise intervention to patients in rural locations (NCI Thesaurus).

Key Inclusion

  • Age 18 to 90 years
  • Diagnosis of breast or prostate cancer
  • Completed curative treatment >3 months and <5 years prior
  • Treatment included hormonal, radiation, chemotherapy, or immunotherapy
  • Rural zip code per HRSA definition
  • Moderate fatigue >3/10
  • Access to high-speed internet and camera-equipped device
  • Physician clearance for exercise if indicated

Key Exclusion

  • ECOG Performance Status ≥2
  • Current or planned cancer treatments in next 6 months except maintenance hormonal therapy
  • Prostate cancer patients on ADT or with ≥12 months prior ADT
  • Plans to relocate to non-rural location within 6 months
  • Disease or condition preventing safe exercise participation
  • Metabolic disease except pre-diabetes, metabolic syndrome, or diabetes on metformin only
  • Current participation in another exercise oncology program

NCT06888102

IIT2023-10-Posadas-PC-Net : A Platform Study of Epigenetic Therapy Before Prostatectomy in Men With Prostate Cancer

Organization/Sponsor: Cedars-Sinai Medical Center


Example patient: A 62-year-old man with localized prostate cancer, ECOG status 0, normal organ function, scheduled for radical prostatectomy with available preoperative biopsy tissue and no prior cancer treatments.

Phase N/A

Interventions

  • Drug: Neoadjuvant Epigenetic Therapy
    Summary: Therapy administered prior to radical prostatectomy to enhance primary treatment effectiveness through epigenetic modulation (NCI Thesaurus).

Key Inclusion

  • Men electing radical prostatectomy with preoperative tissue available
  • Age ≥18 years
  • ECOG performance status 0 or 1
  • AST and ALT < 2.5 x ULN
  • Total bilirubin < 1.5 x ULN
  • Platelets > 90 x 1000/μL
  • Hemoglobin > 8.5 g/dL
  • Serum Creatinine <1.5 x ULN or eGFR > 30 mL/min

Key Exclusion

  • Active intercurrent illness or malignancy requiring therapy outside of prostate cancer
  • Other anti-cancer therapy including chemotherapy, hormonal therapy, radiation, surgery, immunotherapy, biologic therapy, or tumor embolization
  • Participating in investigational medicinal anti-cancer agent study within 4 weeks prior to first dose

NCT07219147

Pilot Study of ¹⁷⁷Lu-PSMA-617 in Combination With Sipuleucel-T in Patients With Metastatic Castration-Resistant Prostate Cancer

Organization/Sponsor: City of Hope Medical Center


Example patient: A 68-year-old male with PSMA-positive metastatic castration-resistant prostate adenocarcinoma with bone and lymph node metastases, on continuous ADT for 18 months with testosterone 25 ng/dL, ECOG 1, who has not received prior sipuleucel-T or lutetium-177 therapy.

Phase N/A

Interventions

  • Biological: Sipuleucel-T
    Summary: Autologous cellular immunotherapy that activates patient immune cells with PAP-GM-CSF fusion protein targeting prostatic acid phosphatase to stimulate anti-tumor T-cell response against prostate cancer cells expressing PAP; indicated for asymptomatic or minimally symptomatic metastatic castrate-resistant prostate cancer (FDA label, NCI Thesaurus).
  • Drug: Lutetium Lu 177 Vipivotide Tetraxetan
    Summary: Radioligand therapeutic agent that binds PSMA on cancer cells via ligand-chelator complex radiolabeled with lutetium-177, delivering targeted beta and gamma radiation to PSMA-positive tumor tissue; indicated for PSMA-positive mCRPC after androgen receptor pathway inhibitor therapy (FDA label, NCI Thesaurus).
  • Procedure: Leukapheresis
    Summary: Procedure that collects white blood cells from peripheral blood while returning remaining blood components to donor; used to obtain cells for sipuleucel-T preparation (NCI Thesaurus).
  • Diagnostic: PSMA PET Scan
    Summary: PET imaging technique using 68Ga-PSMA-11 to bind cancer cells and locate PSMA-expressing lesions for disease assessment (NCI Thesaurus).
  • Diagnostic: Magnetic Resonance Imaging
    Summary: Imaging using radiofrequency waves and strong magnetic field to provide detailed pictures of internal organs and tissues for diagnosis of pathologic conditions including cancer (NCI Thesaurus).
  • Diagnostic: Computed Tomography
    Summary: Method examining body structures by scanning with X-rays and computer reconstruction of cross-sectional images along single axis for disease assessment (NCI Thesaurus).
  • Diagnostic: Bone Scan
    Summary: Nuclear imaging method to evaluate pathological bone metabolism for detection of bone metastases (NCI Thesaurus).
  • Procedure: Biospecimen Collection
    Summary: Collection of biological samples for testing, diagnostic, or research purposes including archival tissue and blood specimens (NCI Thesaurus).

Key Inclusion

  • Progressive castration-resistant metastatic prostate adenocarcinoma without small cell features
  • Age ≥18 years, male, ECOG ≤1
  • Androgen deprivation therapy for ≥3 months with castrate testosterone <50 ng/dL
  • Measurable disease (≥10 mm extranodal, ≥20 mm lymph nodes) or non-measurable disease including bone lesions
  • Adequate hematologic function: ANC ≥1500/mm³, platelets ≥100,000/mm³, hemoglobin ≥9 g/dL
  • Adequate organ function: bilirubin ≤1.5×ULN, AST ≤2.5×ULN, creatinine ≤1.5×ULN
  • Seronegative for HIV, HCV, HBV, and syphilis or undetectable viral load
  • Agreement to use contraception through 4 months after last dose

Key Exclusion

  • Prior treatment with 177Lu-PSMA-617 or sipuleucel-T
  • Anticancer therapy including AR antagonists, chemotherapy, or radiotherapy within 4 weeks
  • Systemic corticosteroids, ketoconazole, or 5-alpha-reductase inhibitors within 28 days
  • Radiation therapy for bone metastasis within 2 weeks
  • Known primary CNS malignancy or symptomatic CNS metastases
  • Active malignancy or diagnosis of another malignancy within 3 years requiring active treatment
  • Known clinically significant liver disease including cirrhosis or active hepatitis
  • Treatment with investigational vaccine within 2 years or other investigational product within 28 days

NCT07210086

Phase II Non-Randomized Study Evaluating POSLUMA-PSMA PET Response After Oligo- Metastatic/Progressive-directed Treatment With Radiotherapy (PROMPT-R)

Organization/Sponsor: City of Hope Medical Center


Example patient: A 62-year-old man with newly diagnosed castration-sensitive prostate adenocarcinoma, testosterone 350 ng/dL, PSA 45 ng/mL, ECOG 0, with three bone metastases in spine and ribs, no visceral disease, eligible for ablative radiotherapy to all sites.

Phase 2

Interventions

  • Other: No ADT/ARSI -decline
    Summary: Patients decline androgen deprivation therapy or androgen receptor signaling inhibitor treatment.
  • Drug: ARSI
    Summary: Androgen receptor signaling inhibitor that blocks AR pathway to suppress prostate cancer growth (NCI Thesaurus).
  • Drug: ADT
    Summary: Androgen deprivation therapy that reduces testosterone levels to castrate range for prostate cancer treatment.

Key Inclusion

  • Age 18 years or older
  • Castration-sensitive prostate adenocarcinoma with rising PSA and testosterone >100
  • De novo oligometastatic or oligoprogressive disease with ≤5 metastatic sites outside pelvis
  • No brain or liver metastases
  • KPS ≥70 or ECOG 0-1
  • Eligible for ablative-intent radiation therapy (BED >100)
  • Primary prostate site controlled or receiving ablative treatment
  • Measurable disease by PERCIST v1.0

Key Exclusion

  • Planning lifelong continuous or intermittent ADT
  • More than 3 months neoadjuvant ADT prior to consent
  • Polymetastatic disease (>5 metastatic sites or brain/liver involvement)
  • Contraindication to flotufolastat F18 or PSMA-PET
  • Uncontrolled HIV, HBV, or HCV infection
  • Other active malignancy interfering with study assessment
  • Clinically significant uncontrolled illness
  • Inability to comply with study procedures

NCT07244341

A Phase 1, Multicenter Trial Evaluating the Safety, Tolerability, and Efficacy of Valemetostat (DS-3201) in Combination With Darolutamide in Metastatic Castration Resistant Prostate Cancer (mCRPC)

Organization/Sponsor: Daiichi Sankyo


Example patient: A 67-year-old male with metastatic castration-resistant prostate adenocarcinoma, PSA 8.5 ng/mL, ECOG PS 1, progressing on abiraterone with ongoing LHRH agonist therapy, no prior epigenetic inhibitor exposure.

Phase 1

Interventions

  • Drug: Darolutamide
    Summary: Androgen receptor inhibitor that blocks androgen-induced receptor activation and prevents transcription of AR-responsive genes regulating prostate cancer cell proliferation, approved for nmCRPC and mCSPC including combination with docetaxel (FDA label, NCI Thesaurus).
  • Drug: Valemetostat
    Summary: Oral selective inhibitor of histone methyltransferases EZH1 and EZH2 that prevents H3K27 methylation, altering gene expression patterns and decreasing proliferation in EZH1/2-expressing cancer cells (NCI Thesaurus).

Key Inclusion

  • Adult males ≥18 years of age
  • Histologically confirmed adenocarcinoma of the prostate
  • Evidence of disease progression per PCWG3 modified RECIST v1.1
  • Metastatic disease confirmed by radiographic imaging
  • Ongoing androgen deprivation therapy
  • Baseline PSA ≥2 ng/mL
  • Prior therapy with Androgen Receptor Pathway Inhibitors
  • ECOG PS of 0 or 1

Key Exclusion

  • Prior treatment with epigenetic agents including EZH1, EZH2, EZH1/2, or PRC2 inhibitors
  • Super scan on baseline bone scan
  • Clinically active brain metastases, spinal cord compression, or leptomeningeal carcinomatosis
  • Uncontrolled or significant cardiovascular disease
  • Prior malignancy active within previous 3 years
  • Active or uncontrolled HBV, HCV, or HIV infection
  • Pure small cell carcinoma diagnosis

NCT07277270

A Phase 1b/2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of GSK5764227 in Combination With Standard of Care (SoC) or Other Agents in Participants With Advanced Solid Tumors

Organization/Sponsor: GlaxoSmithKline


Example patient: A 68-year-old man with metastatic prostate adenocarcinoma, ECOG 1, adequate organ function, no recent surgery or infections, and no history of autoimmune disease or CNS metastases.

Phase 1, Phase 2

Interventions

  • Drug: Enzalutamide
    Summary: An oral androgen receptor inhibitor that blocks AR signaling in prostate cancer cells, reducing proliferation and PSA levels; indicated for castration-resistant and castration-sensitive prostate cancer; induces CYP450 enzymes requiring drug interaction monitoring (FDA label, NCI Thesaurus).
  • Drug: leucovorin
    Summary: A reduced folate derivative used as rescue after methotrexate therapy and combined with 5-fluorouracil for colorectal cancer; bypasses dihydrofolate reductase to enable purine/pyrimidine synthesis and stabilizes 5-FU binding to thymidylate synthase (FDA label, NCI Thesaurus).
  • Drug: Fluorouracil
    Summary: A fluoropyrimidine antimetabolite that inhibits thymidylate synthase and incorporates into RNA/DNA, disrupting nucleic acid synthesis; indicated for adenocarcinomas of colon, rectum, breast, stomach, and pancreas; requires monitoring for bone marrow suppression and GI toxicity (FDA label, NCI Thesaurus).
  • Biological: Bevacizumab
    Summary: A recombinant humanized anti-VEGF monoclonal antibody that blocks tumor angiogenesis by preventing VEGF receptor binding; indicated for multiple advanced cancers including metastatic colorectal cancer; carries risks of hemorrhage, thromboembolism, GI perforation, and hypertension (FDA label, NCI Thesaurus).
  • Drug: GSK5764227
    Summary: An antibody-drug conjugate targeting B7-H3 (CD276) linked to a topoisomerase inhibitor; binds B7-H3 on tumor cells, internalizes, releases TOPOi to inhibit DNA replication causing apoptosis; targets B7-H3 overexpressing tumors where it regulates T-cell activation and promotes invasion/metastasis (NCI Thesaurus).

Key Inclusion

  • ECOG performance status 0 or 1
  • Adequate organ function
  • Histologically confirmed unresectable or metastatic adenocarcinoma of colon or rectum (Cohort A)
  • Histologically or cytologically confirmed adenocarcinoma of the prostate (Cohort B)

Key Exclusion

  • Malignancy requiring active treatment within past 24 months
  • Major surgery within 28 days prior to first dose
  • Significant bleeding symptoms or tendency within 1 month
  • Serious infection within 4 weeks
  • Untreated or progressive brain/CNS metastases
  • Current or prior interstitial lung disease or pneumonitis requiring high-dose glucocorticoids
  • Autoimmune disease requiring systemic treatment in past 2 years
  • Immunosuppressive agents within 30 days or long-term use required

NCT07025512

177Lu-PSMA-617 in Metastatic Castration Resistant Prostate Cancer (mCRPC) With Bone Marrow Involvement and Cytopenia

Organization/Sponsor: M.D. Anderson Cancer Center


Example patient: A 67-year-old man with mCRPC and bone marrow involvement causing anemia (hemoglobin 8.2 g/dL), previously treated with enzalutamide and docetaxel, with rising PSA of 45 ng/mL and PSMA-positive bone metastases on PET/CT.

Phase N/A

Interventions

  • Drug: 177Lu-PSMA-617
    Summary: A radioconjugate targeting PSMA-expressing tumor cells; vipivotide tetraxetan binds to PSMA and delivers beta particle radiation via lutetium-177 to destroy prostate cancer cells. Source: NCI Thesaurus.

Key Inclusion

  • Metastatic castration-resistant prostate cancer with rising PSA ≥2.0 ng/mL
  • Cytopenia due to prostate cancer bone marrow involvement
  • Received ≥1 prior systemic therapy in mCRPC setting
  • Hemoglobin 7-9 g/dL or pretransfusion <8 g/dL, or platelets 50-100 x 10^9/L
  • Positive 68Ga-PSMA-11 PET/CT with uptake > liver parenchyma
  • Serum testosterone <50 ng/dL on ADT or post-orchiectomy
  • ECOG performance status ≤2
  • Adults ≥18 years with histologically confirmed prostate adenocarcinoma

Key Exclusion

  • Primary bone marrow disorder (leukemia, myeloproliferative/myelodysplastic disorder)
  • Prior radiopharmaceutical agents (Strontium-89, PSMA-targeted radioligand therapy)
  • Prior PSMA-targeting therapy
  • Active CNS metastases, leptomeningeal disease, or spinal cord compression
  • Concurrent cytotoxic chemotherapy, immunotherapy, or PARP inhibitor
  • Significant cardiac disease including high-grade AV block or familial long QT syndrome
  • Iron deficiency or other hematological disorders causing anemia
  • Systemic therapy within 2 weeks or investigational agent within 4 weeks

NCT07288359

An Open-label, Multi-center, Phase I/II Study of GVV858 as a Single Agent and in Combination With Endocrine Therapy in Patients With Advanced Hormone Receptor Positive, HER2- Negative Breast Cancer and Other Advanced Solid Tumors Genomic-based

Organization/Sponsor: Novartis


Example patient: A 62-year-old postmenopausal woman with HR+/HER2- metastatic breast cancer and CCNE1 amplification, progressed after two lines of endocrine therapy including letrozole plus palbociclib, with measurable lung metastases and adequate organ function.

Phase 1, Phase 2

Interventions

  • Drug: Letrozole
    Summary: Letrozole is a third-generation nonsteroidal aromatase inhibitor that selectively blocks aromatase enzyme, reducing estrogen synthesis from androgens, thereby inhibiting growth of estrogen-dependent breast cancer cells in postmenopausal women (FDA label, NCI Thesaurus).
  • Drug: Fulvestrant
    Summary: Fulvestrant is a synthetic estrogen receptor antagonist that competitively binds and degrades estrogen receptors, blocking estrogen signaling in HR+/HER2- advanced breast cancer, including tamoxifen-resistant disease; administered intramuscularly (FDA label, NCI Thesaurus).
  • Drug: GVV858
    Summary: GVV858 is an investigational CDK2 inhibitor targeting CCNE1-amplified cancers including metastatic castration-resistant prostate cancer by blocking cell cycle progression; currently in Phase I/II trials (Web Search Summary).

Key Inclusion

  • Age ≥18 years
  • HR+/HER2- advanced breast cancer with progression on CDK4/6 inhibitor plus hormone therapy
  • Locally advanced or metastatic cancer with CCNE1 amplification
  • Metastatic castration-resistant prostate adenocarcinoma with castrate testosterone levels
  • No more than 3 prior lines of systemic therapy for metastatic disease
  • Measurable disease per RECIST v1.1 or evaluable bone lesions
  • Phase II: No prior cytotoxic chemotherapy or antibody-drug-conjugate for advanced disease
  • Phase II: No more than 2 lines of endocrine therapy for advanced disease

Key Exclusion

  • Inadequate bone marrow or organ function
  • Clinically significant uncontrolled heart disease or cardiac repolarization abnormality
  • Symptomatic CNS metastases or CNS metastases requiring increasing corticosteroids
  • Symptomatic visceral disease including visceral crisis
  • Concurrent hormone replacement therapy for breast cancer patients
  • Pregnant, nursing, or women of childbearing potential unwilling to use contraception
  • Long QT syndrome or risk factors for Torsades de Pointes
  • Myocardial infarction or coronary artery bypass graft

NCT07223385

High Cardiovascular Risk Intervention With Cardio-Oncology Consultation for Prostate Cancer Following Androgen Receptor Pathway Inhibitor (ARPI) Therapy (Heart-Safe)

Organization/Sponsor: Cedars-Sinai Medical Center


Example patient: A 68-year-old man with metastatic prostate cancer starting abiraterone therapy who has hypertension and diabetes but no prior cardio-oncology care.

Phase N/A

Interventions

  • Procedure: Notification to PCP/General Cardiologist
    Summary: Communication intervention to inform primary care or cardiology providers about patient cardiovascular risks during cancer treatment to enhance care coordination (Web Search).
  • Procedure: Cardio-Oncology Referral
    Summary: Referral of patient to cardio-oncology specialist for management of cardiovascular risks associated with cancer therapies (NCI Thesaurus).

Key Inclusion

  • Prostate cancer with localized very-high risk, lymph-node positive, or metastatic Stage IV disease
  • Being treated with ARPI therapy with intended duration ≥18 months
  • Age >65 years with at least one CV risk factor
  • Age 45-65 years with at least two CV risk factors
  • CV risk factors: hypertension, hyperlipidemia, diabetes, family history of early CAD, or coronary artery calcium
  • ECOG 0-2

Key Exclusion

  • Prior ARPI therapy exposure >6 months duration
  • Established care with cardio-oncologist

NCT07285057

Diagnostic Utility of rhPSMA-7.3 (18F) PET /CT Imaging in Patients With Prostate Cancer on Active Surveillance

Organization/Sponsor: Icahn School of Medicine at Mount Sinai


Example patient: A 62-year-old male with Grade Group 2 prostate adenocarcinoma, PSA 12 ng/mL, cT2b disease on active surveillance without contraindications to MRI or significant comorbidities.

Phase N/A

Interventions

  • Diagnostic: Flotufolastat F18
    Summary: Flotufolastat F-18 is a radiohybrid PSMA ligand labeled with fluorine-18 for PET imaging of PSMA-positive lesions in prostate cancer. It targets and binds to PSMA-expressing tumor cells, enabling visualization via positron emission with 511 keV gamma photons and a 109.8-minute half-life. FDA-approved for detecting suspected metastasis or recurrence based on elevated PSA (FDA label, NCI Thesaurus).
  • Procedure: rhPSMA-7.3 (18F) PET/CT Imaging
    Summary: An imaging procedure combining rhPSMA-7.3 F18 PET with computed tomography to overlay PSMA activity data onto anatomic images. Used for detecting PSMA-positive lesions in prostate cancer patients with suspected metastasis or recurrence (FDA label, NCI Thesaurus).

Key Inclusion

  • Male participants aged ≥18 years
  • Histologically confirmed prostate adenocarcinoma
  • Low-risk or favorable intermediate-risk prostate cancer per NCCN criteria
  • Grade Group 1-2, PSA <20 ng/mL, cT1-T2c
  • Currently managed with active surveillance
  • Able to undergo rhPSMA-7.3 (18F) PET/CT, mpMRI, and confirmatory biopsy

Key Exclusion

  • History of other active malignancy within last 5 years except non-melanoma skin cancer
  • Contraindication to 3-T mpMRI
  • Significant intercurrent morbidity limiting protocol compliance
  • History of allergic reactions to similar compounds or study agents

NCT07293585

Vascular Optimized Radiotherapy Tuned to Critical Structures for Erectile Function Using High-Precision X-Ray Treatment

Organization/Sponsor: Jonsson Comprehensive Cancer Center


Example patient: A 62-year-old man with ECOG 1, biopsy-confirmed localized prostate adenocarcinoma with a peripheral zone lesion and PSMA PET showing pelvic lymph nodes below the renal arteries, no prior pelvic radiation or ablative therapy.

Phase N/A

Interventions

  • Radiation: Neurovascular sparing stereotactic body radiation therapy
    Summary: Stereotactic radiation therapy delivering one or several maximum dose treatments targeting body cancers while sparing neurovascular structures critical for erectile function (NCI Thesaurus).

Key Inclusion

  • Age ≥18
  • Histologically confirmed clinically localized prostate adenocarcinoma
  • No metastatic disease above renal artery bifurcation
  • Nodal disease below renal arteries allowable on PSMA PET/CT
  • ECOG performance status ≤2
  • Ability to undergo pelvic MRA
  • No urgent or emergent radiation indication

Key Exclusion

  • Neuroendocrine or small cell prostate carcinoma
  • Distant metastases except locoregional lymphadenopathy below renal arteries
  • Intraprostatic lesion in middle third or both lateral thirds of prostate
  • Prior whole-gland cryosurgery, HIFU, brachytherapy, or ablative treatments
  • Prior pelvic radiotherapy
  • History of Crohn's disease, ulcerative colitis, or ataxia telangiectasia
  • Penile prosthesis or implant present

NCT07202247

A Phase II Randomized Study of Interventions for Metabolic Protection Against Cardiometabolic Toxicity During Androgen Deprivation Therapy (IMPACT-ADT)

Organization/Sponsor: City of Hope Medical Center


Example patient: A 62-year-old obese male with BMI 32, hypertension, NCCN intermediate-risk prostate cancer scheduled for definitive radiation and 6-month ADT without prior GLP1-RA use.

Phase II

Interventions

  • Drug: Tirzepatide
    Summary: Dual GIP and GLP-1 receptor agonist that enhances glucose-dependent insulin secretion and improves blood sugar control in type 2 diabetes. Administered as weekly subcutaneous injection (2.5-15 mg) as adjunct to diet and exercise (FDA label).
  • Behavioral: Short-Term Fasting
    Summary: Eating plan alternating between fasting and non-fasting periods, including complete alternate-day fasting, modified fasting regimens, and time-restricted feeding (NCI Thesaurus).
  • Drug: Semaglutide
    Summary: GLP-1 receptor agonist that enhances insulin secretion, reduces glucagon, slows gastric emptying, and suppresses appetite. Used for type 2 diabetes management and cardiovascular/renal risk reduction (FDA label, NCI Thesaurus).
  • Procedure: Referral
    Summary: Sending a patient from one practitioner to another for health care services (NCI Thesaurus).
  • Radiation: Radiation Therapy
    Summary: Treatment by exposure to radiation, often used as curative therapy or palliative treatment for cancer, including total body irradiation prior to transplantation (NCI Thesaurus).
  • Procedure: Questionnaire Administration
    Summary: The act of having an individual fill out a questionnaire (NCI Thesaurus).
  • Behavioral: Nutritional Intervention
    Summary: Diet or dietary change designed to improve or correct an individual's nutritional condition (NCI Thesaurus).
  • Device: Medical Device Usage and Evaluation
    Summary: Header term to classify medical device usage and evaluation of performance (NCI Thesaurus).
  • Behavioral: Lifestyle Counseling
    Summary: Educational intervention to lower early death or illness risks by addressing nutrition, physical activity, sleep, stress, tobacco use, and alcohol use (NCI Thesaurus).
  • Behavioral: Internet-Based Intervention
    Summary: Any program that uses the internet to alter, modify, or eliminate a behavior (NCI Thesaurus).
  • Procedure: Electronic Health Record Review
    Summary: Checking and assessing the data present in an electronic health record (NCI Thesaurus).
  • Diagnostic: Computed Tomography
    Summary: Imaging method using X-rays and computer to construct cross-sectional scans along a single axis (NCI Thesaurus).
  • Diagnostic: Cardiac Computerized Tomographic Angiography
    Summary: Imaging technique of heart and neighboring structures using helical CT and software to generate high-resolution 2D and 3D images (NCI Thesaurus).
  • Procedure: Biospecimen Collection
    Summary: The act or process of gathering biospecimens for testing, diagnostic, propagation, treatment or research purposes (NCI Thesaurus).
  • Behavioral: Behavioral Intervention
    Summary: Use of operant conditioning, including rewards and punishments, to help a person create an atmosphere where they do not contribute to painful stimuli (NCI Thesaurus).
  • Drug: Antiandrogen Therapy
    Summary: Substances that inhibit or antagonize androgen biosynthesis or biologic effects by antagonizing tissue responsiveness or competing with binding sites (NCI Thesaurus).

Key Inclusion

  • Male aged 30-79
  • ECOG 0-2
  • BMI ≥30 kg/m² or BMI ≥27 kg/m² with weight-related comorbidity
  • NCCN intermediate risk prostate cancer receiving definitive radiation with 6-month ADT plan
  • Biochemical persistent or recurrent prostate cancer post-prostatectomy receiving salvage radiation with 6-month ADT plan
  • English, Spanish or Mandarin-speaking
  • High cardiovascular comorbidity burden eligible for GLP1-RA insurance coverage
  • Agreement to allow use of archival tissue from diagnostic tumor biopsies

Key Exclusion

  • Currently engaging in strict macronutrient/time limited diet (ketogenic, low-carb, paleo, warrior)
  • Currently under GLP1-RA therapy
  • Poorly controlled diabetes
  • Unable to undergo time-restricted diet
  • Contraindications for GLP1-RA therapy: hypersensitivity, pancreatitis history, medullary thyroid cancer or MEN type 2 history, end-stage renal disease
  • Other active disease deemed ineligible by treating physician
  • Unable to comply with study procedures

NCT07319871

A Phase 1b Study of Pasritamig (JNJ-78278343), a T-cell Redirecting Agent Targeting Human Kallikrein 2 (KLK2), in Combination With JNJ-86974680, an A2a Receptor (A2aR) Antagonist, for Prostate Cancer

Organization/Sponsor: Janssen Research & Development, LLC


Example patient: A 68-year-old man with metastatic castration-resistant prostate adenocarcinoma with bone and lymph node involvement, PSA of 15 ng/mL, ECOG status 1, on continuous GnRH agonist therapy without visceral metastases.

Phase 1

Interventions

  • Drug: Pasritamig
    Summary: Humanized IgG1 bispecific antibody targeting KLK2 on tumor cells and CD3 on T-cells, redirecting T-cells to lyse KLK2-expressing prostate cancer cells via subcutaneous administration (NCI Thesaurus).
  • Drug: JNJ-86974680
    Summary: Adenosine A2A receptor antagonist that blocks tumor-released adenosine from inhibiting T-lymphocytes, thereby promoting T-cell proliferation, activation, and anti-tumor immune response (NCI Thesaurus).

Key Inclusion

  • Histologically confirmed adenocarcinoma of the prostate
  • Metastatic castration-resistant prostate cancer (mCRPC)
  • Metastatic to bone, lymph node, or both without visceral organ metastasis
  • Ongoing androgen deprivation therapy with GnRH analog
  • PSA ≥2 ng/mL at screening
  • Measurable or evaluable disease
  • ECOG performance status 0 or 1
  • Adenocarcinomas with neuroendocrine features allowed

Key Exclusion

  • Primary small cell, carcinoid, or neuroendocrine carcinoma of prostate
  • Prior anticancer therapy toxicity >Grade 1 (except alopecia, Grade 2 neuropathy, vitiligo)
  • Known allergies to pasritamig or JNJ-86974680 components
  • Active infection requiring systemic antibiotics within 7 days
  • Leptomeningeal disease or untreated/unstable brain metastases
  • Brain metastases requiring corticosteroids within 2 weeks
  • Serious underlying medical conditions impairing treatment tolerance
  • Visceral organ metastases

NCT07225946

A Phase 3 Randomized, Open-label Study of Pasritamig (JNJ-78278343), a T-cell-redirecting Agent Targeting Human Kallikrein 2, With Docetaxel Versus Docetaxel for Metastatic Castration-resistant Prostate Cancer Genomic-based

Organization/Sponsor: Janssen Research & Development, LLC


Example patient: A 68-year-old man with metastatic castration-resistant prostate adenocarcinoma on ongoing ADT with testosterone 35 ng/dL, ECOG 1, who progressed on abiraterone and enzalutamide without prior chemotherapy or known BRCA mutations.

Phase 3

Interventions

  • Drug: Prednisone
    Summary: A synthetic glucocorticoid that binds nuclear receptors to suppress inflammatory cytokine production and induce apoptosis in tumor cells, used for inflammatory and neoplastic conditions (FDA label, NCI Thesaurus).
  • Drug: Docetaxel
    Summary: A microtubule inhibitor that binds and stabilizes tubulin causing cell-cycle arrest at G2/M phase, indicated for castration-resistant prostate cancer and other solid tumors (FDA label, NCI Thesaurus).
  • Biological: Pasritamig
    Summary: A bispecific antibody targeting KLK2 on tumor cells and CD3 on T-cells that redirects T-cell-mediated lysis against KLK2-expressing prostate adenocarcinoma cells (NCI Thesaurus).

Key Inclusion

  • Histologically confirmed adenocarcinoma of the prostate
  • Metastatic disease at screening
  • Ongoing ADT with GnRH analog or prior bilateral orchiectomy
  • Serum testosterone ≤50 ng/dL at screening
  • Progressed on at least 1 but no more than 2 different ARPI
  • Discontinued ARPI before randomization
  • ECOG performance status 0 to 1

Key Exclusion

  • Known brain or leptomeningeal metastases
  • Known BRCA1/2 mutations without prior PARP inhibitor treatment unless unavailable or contraindicated
  • Prior or concurrent second malignancy that could interfere with study endpoints
  • Received cytotoxic chemotherapy for prostate cancer in any setting
  • Prior treatment with KLK-2 directed therapies

NCT07276438

MRI- or CT-Guidance and Online Adaptation With Stereotactic Radiotherapy for Prostate Cancer (MANTICORE)

Organization/Sponsor: Jonsson Comprehensive Cancer Center


Example patient: A 65-year-old man with newly diagnosed clinically localized prostate adenocarcinoma, ECOG status 1, no prior pelvic radiation or ablative treatments, and staging showing no metastases beyond locoregional lymph nodes.

Phase N/A

Interventions

  • Procedure: MRI-guided Stereotactic Body Radiation Therapy
    Summary: Stereotactic body radiation therapy using MR imaging to define and localize the treatment area for precise radiation delivery (NCI Thesaurus).
  • Procedure: CT-guided Stereotactic Body Radiation Therapy
    Summary: Stereotactic body radiation therapy using CT imaging to define and localize the treatment area for targeted radiation (NCI Thesaurus).
  • Procedure: Inter-fraction Adaptation of Treatment Plan
    Summary: Treatment approach modifying the radiation plan between sessions in response to anatomical or tumor changes (NCI Thesaurus).
  • Diagnostic Test: Magnetic Resonance Imaging
    Summary: Imaging using radiofrequency waves and magnetic fields to provide detailed pictures of internal organs for diagnosis and treatment planning (NCI Thesaurus).
  • Diagnostic Test: Computed Tomography
    Summary: Imaging method using X-rays and computer processing to construct cross-sectional scans for anatomical visualization (NCI Thesaurus).
  • Other: Survey Administration
    Summary: Presenting questionnaires to participants to obtain responses for quality of life and outcomes assessment (NCI Thesaurus).
  • Procedure: Biospecimen Collection
    Summary: Gathering biological samples for testing, diagnostic, or research purposes related to treatment response (NCI Thesaurus).

Key Inclusion

  • Age ≥ 18 years
  • Histologically confirmed clinically localized prostate adenocarcinoma
  • Staging workup per NCCN guidelines based on risk grouping
  • No metastatic disease above renal artery bifurcation or in bones/visceral organs
  • Nodal disease below renal artery bifurcation amenable
  • ECOG performance status ≤ 2
  • No indication for urgent or emergent radiation
  • Written informed consent and ability to comply with study requirements

Key Exclusion

  • Neuroendocrine or small cell carcinoma of the prostate
  • Evidence of distant metastases except locoregional lymphadenopathy below renal arteries
  • Prior cryosurgery, HIFU, brachytherapy, or whole prostate ablative treatments
  • Prior pelvic radiotherapy
  • History of Crohn's disease, ulcerative colitis, or ataxia telangiectasia
  • Condition compromising participant safety or data quality

NCT06138067

A Pilot Study of Low Versus High Intensity Patient Navigation Program to Improve the Enrollment on Clinical Trials Among Cancer Patients

Organization/Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins


Example patient: A 62-year-old man with newly diagnosed prostate cancer being treated at Johns Hopkins with an available therapeutic trial identified through medical record review.

Phase N/A

Interventions

  • Behavioral: Low intensity approach
    Summary: Low intensity patient navigation involves minimal intervention such as watchful waiting and monitoring without immediate treatment, focusing on quality of life in cancer patients (Summary of Web Search).
  • Behavioral: High intensity approach
    Summary: High intensity patient navigation employs aggressive treatment methods including high-dose radiation or combined therapies, targeting androgen receptors and DNA damage pathways in advanced cancer (Summary of Web Search).

Key Inclusion

  • Age 18 years or older
  • Current diagnosis of primary solid tumor
  • Prostate cancer or kidney cancer
  • Being seen at SKCCC at Johns Hopkins or Wellspan Health Center
  • Available therapeutic trial determined through pre-screening or medical record review

Key Exclusion

  • None

NCT07128927

Assessing the Feasibility of Web-based Insomnia Treatment Among Prostate Cancer Survivors

Organization/Sponsor: Georgetown University


Example patient: A 58-year-old Black man with stage II prostate cancer diagnosed 2 years ago, currently on active surveillance, experiencing clinically significant insomnia with difficulty falling and staying asleep.

Phase N/A

Interventions

  • Behavioral: Patient education
    Summary: Educational intervention providing information to help patients maintain or improve health, focusing on sleep hygiene practices (NCI Thesaurus).
  • Behavioral: Sleep Healthy Using the Internet (SHUTi)
    Summary: Web-based structured program using cognitive behavioral therapy techniques including stimulus control, sleep restriction, hygiene education, relaxation training, and biofeedback to replace thoughts and behaviors causing insomnia (NCI Thesaurus).

Key Inclusion

  • Age ≥21 years
  • Self-identifies as Black/African American
  • Invasive prostate cancer AJCC stages I-IV diagnosed within 5 years
  • No surgery, chemotherapy, or radiation within previous 3 months
  • Insomnia Severity Index score ≥10
  • Internet access via smart phone, tablet, or computer
  • Able to read and understand English

Key Exclusion

  • Occupation where sleep restriction could cause harm
  • Actively employed in shift work
  • Severe or major psychiatric disorder
  • Seizure disorder or seizure within 12 months
  • Unable to consent

NCT07262619

A Multicenter, Multi-Part, Phase 1/2 Study of EIK1005 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors, Including Checkpoint Inhibitor Naïve Participants With Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) Tumors Genomic-based

Organization/Sponsor: Eikon Therapeutics


Example patient: A 62-year-old man with metastatic MSI-H colorectal cancer who progressed after pembrolizumab therapy, has ECOG status 1, adequate organ function, and no active infections or autoimmune disease.

Phase 1, Phase 2

Interventions

  • Drug: EIK1005
    Summary: EIK1005 is a Werner helicase (WRN) inhibitor targeting microsatellite unstable cancers, showing potential in treating MSI-H and dMMR solid tumors including prostate cancer (Web Search).
  • Biological: Pembrolizumab
    Summary: Pembrolizumab is a humanized anti-PD-1 monoclonal antibody that enhances immune-mediated tumor destruction, FDA-approved for numerous solid and hematologic malignancies (FDA label, NCI Thesaurus).

Key Inclusion

  • Age ≥18 years
  • Life expectancy at least 3 months
  • Histologically or cytologically documented advanced solid tumor
  • Parts 1B and 2: locally confirmed MSI-H or dMMR tumor with archival tissue
  • Part 1A: progressed after or intolerant to at least 1 standard treatment
  • Measurable disease per RECIST 1.1
  • ECOG performance status 0 to 1
  • Adequate organ and marrow function

Key Exclusion

  • Not recovered from prior anti-cancer therapy AEs to Grade ≤1
  • Prior treatment with WRN inhibitor
  • Parts 1B and 2: chronic systemic steroid therapy >10 mg prednisone equivalent within 7 days
  • Additional progressing malignancy requiring active treatment within past 3 years
  • Known active CNS metastases or carcinomatous meningitis
  • Mean resting QTcF >470 ms
  • Active autoimmune disease requiring systemic treatment in past 2 years
  • Active infections requiring systemic therapy