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Monthly Update Report for Trials Started in February 2026


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


Overview

Number of Trials: 11

These 11 trials focus primarily on prostate cancer (9 trials), with additional studies in older cancer survivors with chronic pain and advanced cancer patients with symptom clusters. Prostate cancer trials span diagnostic imaging (PSMA and FAP PET), novel therapeutics (antibody-drug conjugates, radioligand therapy, androgen receptor degraders), radiation therapy optimization, and supportive care interventions (telerehabilitation, mHealth). Most target metastatic castration-resistant prostate cancer (mCRPC) with prior androgen receptor pathway inhibitor exposure. Imaging trials evaluate PSMA-targeted agents for detection and staging. Supportive care studies address physical activity, symptom management, and rural access via telemedicine.

Common Criteria Across Trials

Common Inclusion

  • Age 18 years or older
  • Histologically or cytologically confirmed prostate adenocarcinoma
  • Metastatic castration-resistant prostate cancer (mCRPC) with progression on androgen deprivation therapy
  • Prior treatment with androgen receptor pathway inhibitors (ARPI)
  • ECOG performance status 0-2
  • Adequate organ function (hepatic, renal, hematologic)
  • Life expectancy sufficient for study participation
  • Willing and able to provide informed consent
  • Effective contraception for males of reproductive potential

Common Exclusion

  • Small cell or neuroendocrine prostate cancer histology
  • Active uncontrolled infection or significant intercurrent illness
  • Unstable cardiac disease, recent myocardial infarction, or significant cardiovascular conditions
  • Prior pelvic radiotherapy
  • Active secondary malignancy within past 5 years (except non-melanoma skin cancer)
  • Inadequate organ function (hepatic, renal, hematologic)
  • Recent systemic anticancer therapy within 28 days
  • Known hypersensitivity to study agents
  • Pregnant or breastfeeding
  • Contraindications to required imaging (MRI, PET)

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


NCT07227077

An Adaptive Design for Dosing Physical Activity Among Older Cancer Survivors Who Experience Chronic Pain: a Micro-randomized Trial

Organization/Sponsor: Medical College of Wisconsin


Example patient: A 68-year-old English-speaking man with treated localized prostate cancer without metastases or recurrence who owns a smartphone and experiences chronic pain.

Phase N/A

Interventions

  • Behavioral: Physical Activity Promotion Intervention
    Summary: Uses pedometers and activity tracking to reduce sedentary behavior and increase exercise, targeting behavior change to improve fatigue, functional ability, muscle strength, and quality of life in cancer survivors (NCI Thesaurus, Web Search).

Key Inclusion

  • Age greater than or equal to 65 years
  • History of bladder, breast, cervical, colorectal, endometrial, lung, or prostate cancer diagnosis and treatment
  • Fluent in spoken and written English
  • Access to smartphone

Key Exclusion

  • Metastatic disease
  • Cancer recurrence

NCT07189871

A Phase 1/2a Study of the Safety, Tolerability, and Preliminary Clinical Activity of 177LuBetaBart, a 177Lu-Labeled Anti-B7-H3 Monoclonal Antibody, in Patients With Relapsed/Refractory, Locally Advanced Inoperable, or Metastatic Solid Tumors

Organization/Sponsor: Radiopharm Theranostics, Ltd


Example patient: A 68-year-old man with metastatic castration-resistant prostate cancer progressing on enzalutamide with rising PSA, ECOG status 1, adequate organ function, and life expectancy of 12 months.

Phase 1, Phase 2

Interventions

  • Radiopharmaceutical: 177Lu-BetaBart
    Summary: 177Lu-BetaBart is a radiolabeled monoclonal antibody that targets B7-H3 protein on cancer cells, delivering lutetium-177 radiation directly to tumors for targeted radiotherapy. It is being studied for treatment of various solid tumors including CRPC, CRC, NSCLC, SCLC, HNSCC, ovarian, cervical, endometrial, TNBC, and ESCC (Source: Web Search).

Key Inclusion

  • Age ≥18 years with histopathologically confirmed CRPC, CRC, NSCLC, SCLC, HNSCC, ovarian, cervical, endometrial, TNBC, or ESCC
  • Progressive CRPC with castrate testosterone levels and documented progression by PSA, soft tissue, bone disease, or PSMA PET
  • Metastatic disease documented on conventional imaging or PSMA PET
  • Progression following ADT and at least one ARSI for CRPC patients
  • Refractory to or intolerant of standard of care therapy or no standard therapy available
  • At least 1 measurable target lesion per RECIST v1.1 (except CRPC)
  • ECOG performance status ≤2
  • Life expectancy ≥4 months

Key Exclusion

  • Prior Lu-177-PSMA radioligand therapy for CRPC patients
  • eGFR <50 mL/min, platelet count <100×10⁹/L, ANC <1.5×10⁹/L, hemoglobin <9 g/dL
  • ALT or AST >3×ULN (>5×ULN with liver metastases), total bilirubin >1.5×ULN
  • Residual toxicity ≥Grade 2 from prior anti-cancer therapy except alopecia and peripheral neuropathy
  • Clinically significant cardiovascular disease including NYHA Class II or greater CHF, QTcF >480 msec
  • Active hepatitis B or C infection
  • Presence of superscan by bone scan for CRPC patients
  • Anti-cancer therapy within 28 days or 5 half-lives prior to first dose

NCT07332455

A Phase 1/2 First-Time-in-Human, Open-label, Multicenter, Dose Escalation and Dose Optimization Study of GSK5471713 in Adult Participants With Metastatic Castration Resistant Prostate Cancer (mCRPC)

Organization/Sponsor: GlaxoSmithKline


Example patient: A 68-year-old man with metastatic castration-resistant prostate adenocarcinoma, ECOG status 1, progressing on ADT after one prior ARPI and two taxane chemotherapy regimens, with no cardiac disease or prior AR degrader therapy.

Phase 1, Phase 2

Interventions

  • Drug: GSK5471713
    Summary: GSK5471713 is an experimental drug for metastatic castration-resistant prostate cancer (mCRPC) being evaluated for safety, efficacy, and pharmacokinetics in first-time-in-human trials. Source: Summary of Web Search.

Key Inclusion

  • Histologically or cytologically confirmed adenocarcinoma of the prostate
  • Metastatic castration-resistant prostate cancer (mCRPC)
  • Prostate cancer progression while on androgen deprivation therapy (ADT)
  • ECOG performance status 0 or 1
  • Progression on ADT and ≥1 prior androgen receptor pathway inhibitor (ARPI)
  • Received 1-2 prior taxane-based chemotherapy regimens

Key Exclusion

  • Small cell or neuroendocrine carcinoma of the prostate
  • Any histology different from adenocarcinoma
  • Impaired cardiac function or clinically significant cardiac disease
  • Uncontrolled infection or clinically significant laboratory abnormality
  • Prior therapy with androgen receptor (AR) degrader targeted therapy

NCT07325721

Hypofractionated Radiotherapy With a Focal Microboost for High-Risk and Locally Advanced Prostate Cancer

Organization/Sponsor: Medical University of South Carolina


Example patient: A 67-year-old man with newly diagnosed Gleason 9 prostate cancer, PSA 35 ng/mL, cT3b disease, ECOG 1, with pelvic lymph node involvement on PSMA PET/CT and PI-RADS 5 lesion on MRI, eligible for long-term ADT.

Phase N/A

Interventions

  • Radiation: Hypofractionated radiation with a microboost
    Summary: External beam radiation therapy delivered in fewer treatments with larger doses per fraction, including a focal microboost to MRI-visible targets (PI-RADS ≥4). Source: NCI Thesaurus.

Key Inclusion

  • Biologically male patients aged 18 years and older
  • Previously untreated prostate cancer with cytotoxic chemotherapy, cryotherapy, ablative treatment, surgical or radiation therapy
  • High risk, very high risk or non-metastatic pelvic lymph node positive prostate cancer per NCCN criteria
  • PSA >20 ng/mL or cT3a-T4 or Gleason score 8-10 or N1M0 pelvic lymph node positive
  • ECOG performance status 0-2
  • At least one MRI visible target for microboost (PI-RADS ≥4 version 2.0)
  • Eligible to receive long term ADT for 12-36 months
  • Adequate hematologic and hepatic function

Key Exclusion

  • Definitive radiologic evidence of metastatic disease outside of pelvic nodes
  • Prior pelvic radiotherapy
  • Life expectancy less than 5 years
  • Prior total prostatectomy, cryotherapy, HIFU, or other ablative prostate treatments
  • Prior or concurrent invasive pelvic malignancy unless disease free for minimum 5 years
  • Pharmacologic androgen ablation started >90 days prior to registration
  • Inability to undergo implantation of gold fiducial markers or rectal spacer gel
  • Concurrent use of testosterone supplementation unless discontinued by registration

NCT06906471

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

Organization/Sponsor: Antelope Surgical Solutions, Inc


Example patient: A 68-year-old man with elevated PSA and abnormal digital rectal exam findings scheduled for multi-core prostate biopsy, with normal kidney function (CrCl 75 mL/min) and no recent radioisotope therapy.

Phase N/A

Interventions

  • Drug: AS1986NS
    Summary: AS1986NS is a fluorescent imaging agent targeting prostate-specific membrane antigen (PSMA) to stain cancer cells, administered via intravenous injection for prostate cancer detection during histopathology evaluation (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

NCT07093177

Multimodal Telerehabilitation of Rural Patients With Advanced Prostate Cancer

Organization/Sponsor: University of Utah


Example patient: A 67-year-old man from a rural Utah community with metastatic prostate cancer on ADT, not currently exercising regularly, with stable cardiovascular health and access to a cell phone.

Phase N/A

Interventions

  • Behavioral: Telerehabilitation Unit
    Summary: Remote physical therapy intervention designed to improve physical fitness and quality of life in prostate cancer patients by managing cancer-related symptoms and treatment side effects (Source: Web Search).

Key Inclusion

  • Age 18 and older
  • Confirmed diagnosis of prostate cancer
  • Receiving standard-of-care ADT for high-risk, locally advanced prostate cancer
  • Receiving ADT as part of multicomponent management of metastatic prostate cancer
  • Residing in a rural community as indicated by zip code in RUCA areas

Key Exclusion

  • Unstable angina, uncontrolled hypertension, recent myocardial infarction
  • Pacemakers
  • Painful or unstable bony metastases
  • Recent skeletal fractures
  • Engaged in a regular exercise rehabilitation program
  • Relocation plans within next 3 months
  • Participating in another clinical trial
  • Lack of working telephone line or cell phone

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 Imaging Agent: Flotufolastat F18
    Summary: 18F-labeled radiohybrid PSMA-targeted PET imaging agent that binds prostate-specific membrane antigen on prostate cancer cells to detect suspected metastasis and recurrence (Summary of Web Search).

Key Inclusion

  • Male participants aged ≥18 years
  • Histologically confirmed prostate adenocarcinoma
  • Low-risk (Grade Group 1, PSA <10 ng/mL, cT1-T2a) or favorable intermediate-risk (Grade Group 2, PSA 10-20 ng/mL, cT2b-c) per NCCN criteria
  • Currently managed with active surveillance
  • Able to undergo rhPSMA-7.3 (18F) PET/CT imaging, mpMRI, and confirmatory prostate biopsy
  • Able to provide written informed consent

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 compounds similar to study agents

NCT06842498

A Phase 2 Dose Optimization Trial Evaluating a CD46-Targeted Antibody-Drug Conjugate (FG-3246) in Patients With Metastatic Castration-Resistant Prostate Cancer Genomic-based

Organization/Sponsor: Kyntra Bio


Example patient: A 68-year-old man with metastatic castration-resistant prostate adenocarcinoma who progressed on enzalutamide, has testosterone <50 ng/dL, bone metastases on imaging, no BRCA mutations, and no peripheral neuropathy.

Phase 2

Interventions

  • Drug: FG-3246
    Summary: An antibody-drug conjugate targeting CD46 receptor on tumor cells, delivering a cytotoxic payload upon internalization to kill cancer cells while sparing normal tissues. Used for metastatic castration-resistant prostate cancer. Source: NCI Thesaurus.

Key Inclusion

  • Histological/cytological confirmation of prostate adenocarcinoma
  • Serum testosterone <50 ng/dL during screening
  • Progressed on one prior second-generation ARSI (abiraterone, enzalutamide, apalutamide, or darolutamide)
  • Progressive mCRPC following last treatment at screening
  • At least 1 metastatic lesion on CT, MRI, or bone scan within 28 days prior to randomization
  • Adequate organ function during screening and Day -1 or Day 1
  • Agree to biopsy or provide archival tissue from after castration resistance developed

Key Exclusion

  • Previous treatment with CD46-targeted therapeutic
  • Small cell neuroendocrine or non-adenocarcinoma component
  • More than one prior second-generation ARSI
  • Systemic anticancer therapy within 28 days prior to randomization
  • Known actionable mutation (e.g., BRCA1) with available approved therapies unless inappropriate or refused
  • NCI CTCAE Grade ≥2 peripheral neuropathy
  • Prior chemotherapy except one taxane-based regimen in castration-sensitive setting completed >12 months before randomization
  • Requires strong CYP3A4 inhibitor or inducer that cannot be safely discontinued

NCT07102212

Randomized Clinical Trial of a Telemedicine-mHealth Symptom Cluster Intervention for Advanced Cancer Patients: Increasing Access in Rural Areas

Organization/Sponsor: Ohio State University Comprehensive Cancer Center


Example patient: A 62-year-old English-speaking man with stage IV prostate cancer experiencing moderate insomnia and fatigue, who uses email regularly and has an ECOG performance status of 1.

Phase N/A

Interventions

  • Behavioral: mHealth Intervention
    Summary: Mobile technology-based intervention using telemedicine to address symptom clusters including insomnia, depression, anxiety, and fatigue in advanced cancer patients, providing personalized support and tracking (Web Search, NCI Thesaurus).

Key Inclusion

  • Advanced cancer (stage IIIb/c or IV lung, stage IV breast, stage IV prostate, advanced multiple myeloma, stage IIIb/IV melanoma)
  • Age 18 years or older
  • Able to read and write in English
  • Use internet and email
  • Meet clinical cut-offs on at least two symptoms: insomnia (ISI ≥8), depression (PHQ-2 ≥3), anxiety (GAD-2 ≥2), or fatigue (FSI ≥3)

Key Exclusion

  • Night-shift work
  • Untreated bipolar disorder
  • Substance use disorder
  • Cognitive impairment
  • ECOG performance status 3 or greater (in bed 50% or more of day)
  • Less than 6 months predicted survival

NCT07237269

Abiraterone/Prednisone + Standard ADT vs Standard ADT for Prostate Cancer Patients With PSMA-Positive Conventional Imaging Negative Pelvic Lymphadenopathy

Organization/Sponsor: University of Nebraska


Example patient: A 62-year-old man with newly diagnosed localized prostate cancer and a small PSMA-positive pelvic lymph node on imaging, ECOG 1, no prior treatment, and no significant cardiac or metabolic comorbidities.

Phase N/A

Interventions

  • Drug: Hormone therapy
    Summary: Hormone therapy targets androgen receptors to reduce testosterone levels, slowing prostate cancer growth, including treatments like abiraterone and enzalutamide (Source: Web Search).

Key Inclusion

  • Histopathologically proven local prostate cancer
  • Targetable PSMA-avid pelvic lymph node <1cm in short axis
  • No prior definitive treatment or intervention
  • ECOG performance status ≤2
  • Age ≥30 years
  • Able to swallow medications

Key Exclusion

  • Distant metastatic disease outside pelvic lymph nodes
  • Inflammatory bowel disease or connective tissue disorders
  • Unstable angina or CHF requiring hospitalization within 3 months
  • Myocardial infarction within 3 months
  • Stroke or TIA within 3 months
  • Uncontrolled diabetes mellitus
  • Thromboembolic events in past month
  • Total bilirubin ≥1.5X ULN, ALT/AST ≥2.5X ULN

NCT06675357

Novel FAP-targeted Approach to Imaging Patients With or High-risk for Metastatic Prostate Cancer

Organization/Sponsor: University of Wisconsin, Madison


Example patient: A 62-year-old man with diagnosed prostate cancer who recently completed standard-of-care PSMA PET imaging and is able to undergo additional PET/MRI research imaging without delaying treatment.

Phase N/A

Interventions

  • Diagnostic Imaging: Magnetic Resonance Imaging
    Summary: MRI uses radiofrequency waves and magnetic fields to provide detailed images of internal organs and tissues for cancer diagnosis and monitoring (NCI Thesaurus).
  • Diagnostic Imaging: Positron Emission Tomography (PET)
    Summary: PET uses radiotracers targeting prostate-specific membrane antigen (PSMA) to detect prostate cancer, aiding in staging and treatment monitoring (Summary of Web Search).
  • Radiopharmaceutical: FAPI
    Summary: Gallium Ga 68 FAPi-46 is a quinoline-based radiotracer targeting fibroblast activation protein (FAP) overexpressed in cancer cells for PET imaging (NCI Thesaurus).

Key Inclusion

  • Age 18 years or older
  • Known diagnosis of prostate cancer
  • Scheduled for or recently performed standard-of-care PSMA PET within 4 weeks
  • Willing and able to undergo PET/MRI as part of research
  • Able and willing to provide informed consent

Key Exclusion

  • Unable or unwilling to provide informed consent
  • Contraindication to or inability to undergo PET/MRI
  • PET/MRI will delay timely delivery of treatment
  • Requiring intravenous conscious sedation for imaging care