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Monthly Update Report for Trials Started in March 2026


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


Overview

Number of Trials: 19

These 19 trials focus on advanced prostate cancer (predominantly metastatic castration-resistant prostate cancer, mCRPC) and include studies of novel therapeutics, imaging-guided interventions, and supportive care. Key themes include radioligand therapy (PSMA-617), androgen receptor pathway inhibitors (darolutamide, enzalutamide, abiraterone), immunotherapy (pembrolizumab, sipuleucel-T), and experimental agents (pacritinib, inavolisib, axelopran, mahatinib). Several trials explore combination strategies, de-escalation approaches guided by PSMA-PET imaging, and quality-of-life interventions such as opioid-free analgesia and exercise programs. Trials also address erectile dysfunction recovery post-prostatectomy and diagnostic imaging improvements.

Common Criteria Across Trials

Common Inclusion

  • Histologically or cytologically confirmed prostate adenocarcinoma
  • Metastatic castration-resistant prostate cancer (mCRPC) with progression on androgen deprivation therapy
  • Castrate testosterone level <50 ng/dL
  • ECOG performance status 0-2
  • Age ≥18 years
  • Adequate organ function (liver, kidney, bone marrow)
  • Life expectancy ≥3 months or longer
  • Ability to provide informed consent

Common Exclusion

  • Small cell or neuroendocrine prostate cancer histology
  • Active brain metastases or CNS disease
  • Uncontrolled intercurrent illness or active infection
  • Significant cardiovascular disease (myocardial infarction, heart failure, arrhythmia within 6 months)
  • Prior treatment with the investigational agent being studied
  • Concurrent other malignancies requiring active treatment
  • Inability to comply with study procedures
  • Active hepatitis B, C, or HIV infection

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


NCT07476001

A Phase 2a Study of High Dose Testosterone Followed by Targeted Radioligand Therapy in Metastatic Castration Resistant Prostate Cancer

Organization/Sponsor: H. Lee Moffitt Cancer Center and Research Institute


Example patient: A 68-year-old man with metastatic castration-resistant prostate cancer, ECOG 1, castrate testosterone levels, PSA progression after 6 months of enzalutamide, positive PSMA PET scan, no visceral metastases, and adequate organ function.

Phase 2

Interventions

  • Radioligand Therapy: PSMA-617
    Summary: PSMA-617 (lutetium Lu 177 vipivotide tetraxetan) is a radioconjugate targeting prostate-specific membrane antigen (PSMA) on tumor cells, delivering beta particle radiation to destroy PSMA-expressing prostate cancer cells. FDA approved for taxane-naive metastatic castration-resistant prostate cancer. Source: NCI Thesaurus, Web Search.
  • Hormonal Therapy: ADT with Luteinizing hormone-releasing hormone (LHRH) analog
    Summary: LHRH analogs suppress testosterone by desensitizing pituitary GnRH receptors, inhibiting LH and FSH secretion, achieving castration-level testosterone to slow androgen-dependent prostate cancer progression. Used for maintaining castrate testosterone levels during trial. Source: NCI Thesaurus, Web Search.
  • Hormonal Therapy: Testosterone cypionate (Tc)
    Summary: Testosterone cypionate is an androgen receptor agonist providing exogenous testosterone, investigated in prostate cancer to re-sensitize tumors to hormone therapy through high-dose testosterone exposure. An eight-carbon ester prodrug administered intramuscularly. Source: FDA label, NCI Thesaurus, Web Search.

Key Inclusion

  • Histologically or cytologically confirmed prostate cancer progressed to mCRPC
  • No grade 2 or above cancer related symptoms
  • PSA or imaging progression at castrate testosterone level (<50ng/dl) per PCWG3 criteria
  • Positive PSMA PET scan eligible for PSMA-617
  • Prior treatment with one line of ARPI for at least 4 weeks
  • ECOG performance status 0-1
  • Adequate organ and marrow functions
  • Left ventricle ejection fraction above 40% if history of MI or CHF

Key Exclusion

  • Known epidural, liver or brain metastases
  • History of cord compression
  • Radiation treatment within 30 days prior to first dose
  • Receiving other investigational agents without 4-week washout
  • Uncontrolled intercurrent illness or active infection
  • Symptomatic congestive heart failure or unstable angina
  • Cardiac arrhythmia
  • Delayed healing of wounds, ulcers, or bone fractures

NCT07427043

Robotic Opioid-free Prostatectomy Enhanced Strategy (ROPES): Implementation of an Opioid-free Multimodal Analgesia Discharge Pathway

Organization/Sponsor: Brigham and Women's Hospital


Example patient: A 58-year-old man with localized prostate cancer, normal kidney function, no NSAID allergies, and no history of opioid use, scheduled for robotic-assisted laparoscopic prostatectomy.

Phase N/A

Interventions

  • Procedure: pre-implementation baseline including opioid
    Summary: Pre-implementation baseline assessing standard opioid use for pain management before introducing new interventions, focusing on optimizing dosages and reducing toxicity in prostate cancer patients with severe pain (Summary of Web Search).
  • Procedure: multimodal analgesia pathway without up-front small opioid prescription
    Summary: Opioid-free multimodal analgesia using NSAIDs, acetaminophen, and local anesthetics to manage postoperative pain, aiming to reduce opioid dependence after prostate cancer surgery (Summary of Web Search).
  • Procedure: multimodal analgesia pathway with up-front small opioid prescription
    Summary: Multimodal analgesia combining non-opioid medications with small upfront opioid prescription, targeting multiple pain pathways to minimize opioid reliance after prostate cancer surgery (Summary of Web Search).

Key Inclusion

  • Men ≥45 years old
  • Undergoing Robotic Assisted Laparoscopic Prostatectomy (RALP)
  • At BWH or BWFH
  • Able to provide informed consent

Key Exclusion

  • Chronic kidney disease (baseline Cr >1.3)
  • NSAID contraindication/allergy
  • Regular opioid use prior to surgery
  • Substance abuse prior to surgery
  • Inability to provide own consent
  • Deviation from standard surgical practice for RALP
  • Major complication requiring operative intervention

NCT07226713

A Single-Arm, Open-label, Phase II Study Evaluating Pacritinib in Participants With Metastatic Castrate-Resistant Prostate Cancer That Progressed on or After Prior Treatment With Androgen Receptor Signaling Inhibitors - (POSTPONE) Genomic-based

Organization/Sponsor: Medical College of Wisconsin


Example patient: A 68-year-old man with metastatic castrate-resistant prostate adenocarcinoma showing STAT5 activation on fresh biopsy, testosterone 25 ng/dL, ECOG 1, progressed on enzalutamide, with adequate organ function and no cardiac comorbidities.

Phase 2

Interventions

  • Drug: Pacritinib
    Summary: Pacritinib is an orally bioavailable JAK2, JAK2V617F, and FLT3 kinase inhibitor that blocks JAK-STAT signaling to induce apoptosis and inhibit proliferation in cancer cells. FDA-approved for myelofibrosis with thrombocytopenia, it is being studied in metastatic castrate-resistant prostate cancer. Sources: FDA label, NCI Thesaurus.

Key Inclusion

  • Metastatic castrate-resistant prostate adenocarcinoma with progression on androgen receptor signaling inhibitor
  • Serum testosterone <50 ng/dL
  • ECOG performance status 0-1
  • Positive STAT5 activation status (>5% nuclear localized Stat5 in cancer cells)
  • Fresh tumor biopsy obtained within 30 days of treatment
  • Left ventricular ejection fraction ≥50%
  • No prior JAK2 inhibitor treatment
  • Adequate organ function including GFR >45 ml/min

Key Exclusion

  • Negative STAT5 activation status in prostate cancer biopsies
  • Prior pacritinib treatment
  • Strong CYP3A4 inhibitors or inducers within 14 days
  • Baseline severe hepatic impairment (Child-Pugh Class B or C)
  • Medications increasing bleeding risk including anticoagulants (except aspirin ≤100 mg/day)
  • QTcF prolongation >450 ms or medications prolonging QT interval
  • NYHA Class II-IV congestive heart failure or cardiac conditions Grade ≥2 within 6 months
  • Active gastrointestinal disorder interfering with oral medication absorption

NCT07142551

Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response Via Modulation of ANdrogen Receptor (the SPIDERMAN Trial)

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


Example patient: A 65-year-old man with metastatic prostate adenocarcinoma, rising PSA of 8.5 ng/ml, bone metastases on imaging, no prior systemic therapy, performance status 1, and no bone pain.

Phase N/A

Interventions

  • Drug: Darolutamide
    Summary: Darolutamide is an androgen receptor inhibitor that blocks androgen-induced receptor activation and prevents transcription of AR-responsive genes regulating prostate cancer cell proliferation, used for non-metastatic castration-resistant and metastatic castration-sensitive prostate cancer (FDA label, NCI Thesaurus).
  • Drug: Luteinizing hormone-releasing hormone (LHRH) analogue
    Summary: LHRH analogues suppress testosterone production by desensitizing GnRH receptors, leading to decreased luteinizing hormone and reduced testosterone levels for advanced prostate cancer treatment (FDA label, NCI Thesaurus).
  • Drug: Testosterone cypionate
    Summary: Testosterone cypionate is an androgen receptor agonist providing exogenous testosterone, typically used for hypogonadism replacement therapy but studied here for supraphysiologic testosterone priming effects in prostate cancer (FDA label, NCI Thesaurus).

Key Inclusion

  • Age ≥18 years with performance status ≤2
  • Histologically confirmed adenocarcinoma of the prostate
  • Baseline PSA ≥1.0 ng/ml with rising PSA on two successive dates >2 weeks apart
  • Evidence of metastatic disease on CT or bone scan within six weeks of screening
  • No prior androgen deprivation therapy for biochemically recurrent or metastatic disease
  • No prior ARPI treatment (abiraterone, enzalutamide, darolutamide) for biochemically recurrent or metastatic disease
  • Patients with bone pain must be pain free at end of 6-month lead-in phase to receive BAT
  • Patients with soft tissue lesions amenable to biopsy must agree to baseline and 6-month tumor biopsies

Key Exclusion

  • Prior chemotherapy or PSMA-targeted agents (Pluvicto)
  • Disease that would put patient at risk from testosterone therapy (femoral metastases with fracture risk, spinal cord compression risk, ureteral obstruction risk)
  • Requires urinary self-catheterization for voiding due to obstruction
  • Anticoagulation therapy with Warfarin or Coumadin
  • Hematocrit >51%, untreated severe obstructive sleep apnea, uncontrolled heart failure
  • Allergy to sesame seed oil or cottonseed oil
  • NYHA class III or IV heart failure or myocardial infarction within last five years
  • Major surgery within 3 weeks or unhealed surgical wound

NCT07027124

Neoadjuvant ADT and Darolutamide With Pembrolizumab, Followed by Adjuvant Pembrolizumab in NCCN High-risk and Molecularly Stratified Prostate Cancer Patients Genomic-based

Organization/Sponsor: Icahn School of Medicine at Mount Sinai


Example patient: A 62-year-old male with newly diagnosed Gleason 9 prostate adenocarcinoma, PSA 35 ng/mL, clinical stage T3b, Decipher score 0.75 with high AR activity and Luminal B subtype, ECOG 0, no metastases, and adequate organ function.

Phase N/A

Interventions

  • Drug: Lupron
    Summary: Leuprolide is a GnRH agonist that suppresses pituitary production of testosterone by desensitizing GnRH receptors, reducing testosterone to castration levels in prostate cancer treatment (FDA label, NCI Thesaurus).
  • Drug: Pembrolizumab
    Summary: Pembrolizumab is a humanized monoclonal antibody that blocks PD-1 receptor, preventing ligand binding and activating T-cell-mediated immune responses against tumor cells (FDA label, NCI Thesaurus).
  • Drug: Darolutamide
    Summary: Darolutamide is an androgen receptor inhibitor that blocks androgen-induced receptor activation, preventing nuclear translocation and transcription of AR-responsive genes in prostate cancer cells (FDA label, NCI Thesaurus).

Key Inclusion

  • Male age ≥18 years with histopathologically confirmed prostate adenocarcinoma
  • NCCN high-risk localized or locally advanced disease: Gleason ≥8, PSA >20 ng/ml, or clinical stage >cT2C
  • Decipher Genomic Classifier >0.6 with high AR activity score >11 and Luminal B subtype
  • ECOG performance status 0-1
  • Adequate organ function: ANC ≥1,500/mcL, platelets ≥100,000/mcL, hemoglobin ≥9 g/dL
  • Hepatic function: bilirubin ≤1.5 mg/dL, AST/ALT ≤2.5x ULN
  • Renal function: creatinine clearance ≥30 mL/min
  • Prior neoadjuvant hormonal therapy allowed if completed ≥12 months ago with recovery from adverse events

Key Exclusion

  • Metastatic disease or Gleason score <8
  • Biopsy Decipher score ≤0.6
  • Prior radiation therapy, chemotherapy, or androgen receptor inhibitors for prostate cancer
  • Active cardiac disease within 6 months including myocardial infarction or congestive heart failure
  • Prior treatment with anti-PD1, anti-PDL1, or other checkpoint inhibitors
  • Active viral hepatitis B or C with detectable viral load, or HIV with detectable viral load
  • Active autoimmune disease requiring systemic therapy in past 2 years
  • Chronic systemic steroid therapy exceeding 10 mg daily prednisone equivalent within 7 days

NCT07287150

A Phase II, Randomized, Multicenter, Open-Label Study Evaluating the Efficacy and Safety of the Combination of Inavolisib Plus Enzalutamide Versus Physician's Choice of ARPI or Docetaxel in Patients With Metastatic Castration-Resistant Prostate Cancer Genomic-based

Organization/Sponsor: Hoffmann-La Roche


Example patient: A 68-year-old man with metastatic CRPC showing PSA progression after one prior abiraterone treatment, ECOG status 0, normal glucose and HbA1c, no liver metastases or diabetes, with available tumor tissue for biomarker testing.

Phase II

Interventions

  • Drug: Docetaxel
    Summary: Docetaxel is a microtubule inhibitor chemotherapy that stabilizes tubulin, preventing cell division and causing cell death. It is FDA-approved for castration-resistant prostate cancer and other solid tumors. Source: FDA label, NCI Thesaurus.
  • Drug: Abiraterone
    Summary: Abiraterone acetate is a CYP17 inhibitor that blocks androgen synthesis by inhibiting 17α-hydroxylase/C17,20-lyase, reducing testosterone production. It is FDA-approved for metastatic CRPC and CSPC in combination with prednisone. Source: FDA label, NCI Thesaurus.
  • Drug: Enzalutamide
    Summary: Enzalutamide is an androgen receptor inhibitor that blocks AR signaling and induces CYP450 enzymes. It is FDA-approved for castration-resistant and castration-sensitive prostate cancer. Source: FDA label, NCI Thesaurus.
  • Drug: Inavolisib
    Summary: Inavolisib is an oral PI3K inhibitor targeting PIK3CA mutations, preventing activation of PI3K-mediated signaling and inhibiting tumor cell growth. FDA-approved for PIK3CA-mutated breast cancer; being studied in prostate cancer. Source: FDA label, NCI Thesaurus.

Key Inclusion

  • Histologically or cytologically confirmed adenocarcinoma of the prostate without small-cell or neuroendocrine features
  • Progressive metastatic CRPC with PSA progression, soft tissue progression, or bone disease progression
  • Treatment with one prior second-generation ARPi for HSPC or CRPC
  • Availability of tumor tissue specimen suitable for biomarker status determination
  • ECOG Performance Status of 0 or 1
  • Fasting glucose <100 mg/dL and HbA1c <5.7%

Key Exclusion

  • Presence of liver metastasis
  • Prior treatment with PI3K, AKT, or mTOR inhibitors
  • Type 1 or Type 2 diabetes mellitus
  • Prior cytotoxic chemotherapy or novel hormonal treatments for mCRPC with specific exceptions
  • Other concurrent anti-cancer therapy except androgen deprivation therapy
  • Treatment with strong CYP2C8 inhibitors or inducers or strong CYP3A4 inducers within specified timeframes
  • Transfusion within 28 days of enrollment for eligibility purposes

NCT07504835

GET FIT Together: Testing a Socially Enhanced Exercise Program in Older Men With Prostate Cancer

Organization/Sponsor: OHSU Knight Cancer Institute


Example patient: A 68-year-old man with prostate cancer who completed radiation therapy 6 months ago, experiences loneliness, can walk independently with a cane, and has reliable home internet access.

Phase N/A

Interventions

  • Behavioral: Training and Education
    Summary: Training and education to improve understanding of genetic testing and lifestyle adherence through interdisciplinary counseling and simulation-based education, enhancing knowledge and decision-making regarding prostate cancer treatment (Summary of Web Search, NCI Thesaurus).
  • Other: Questionnaire Administration
    Summary: Patient self-reported questionnaires to assess quality of life, psychological and physical impacts, and subjective experiences during treatment (Summary of Web Search, NCI Thesaurus).
  • Other: Physical Performance Testing
    Summary: Tests evaluating exercise capacity and physical function including walking speed and timed up and go to assess fitness and guide treatment management (Summary of Web Search, NCI Thesaurus).
  • Behavioral: Exercise Intervention
    Summary: Managed physical activity program targeting cancer-related fatigue and quality of life, modulating tumor microenvironment via mechanisms like p53 activation and autophagy (Summary of Web Search, NCI Thesaurus).
  • Behavioral: Communication Intervention
    Summary: Intervention to improve patient-physician dialogue and interpersonal communication, targeting attitudes and beliefs to enhance informed decision-making and trial participation (Summary of Web Search, NCI Thesaurus).

Key Inclusion

  • Age 65 years or older
  • Histologically confirmed prostate cancer
  • Completed surgery, chemotherapy, radiation or systemic treatment >3 months ago
  • Experiencing cancer loneliness (average score >1 on Cancer Loneliness scale)
  • Able to ambulate independently with or without assistive devices (excluding wheelchair)
  • Willing to be randomized and attend 80% or more of exercise sessions
  • Home internet sufficient for videoconferencing

Key Exclusion

  • Participating in regular group exercise or structured resistance training with other cancer survivors
  • Contraindication to exercise per ACSM criteria
  • Health or medical condition affecting movement or neurological disorder
  • Medication contraindicating participation in live remote resistance exercise
  • Cognitive difficulties precluding survey completion or informed consent
  • Not fluent in English

NCT07221825

Low-Count Quantitative SPECT for Men Treated With Radium-223

Organization/Sponsor: Washington University School of Medicine


Example patient: A 68-year-old man with castration-resistant prostate cancer, ECOG status 2, presenting with painful bone metastases in spine and pelvis (5 lesions), eligible for Radium-223 therapy without visceral disease.

Phase N/A

Interventions

  • Diagnostic Imaging: Low-count quantitative single-photon emission computed tomography imaging
    Summary: LC-QSPECT uses gamma photon-emitting radionuclides detected by rotating gamma cameras to create three-dimensional images via computer reconstruction, providing reliable dose quantification for assessing prostate cancer bone metastases treatment (NCI Thesaurus, Web Search).

Key Inclusion

  • Histologically or cytologically confirmed castration-resistant prostate cancer
  • Symptomatic bone metastases
  • Minimum detectable skeletal lesion count of 3
  • Eligible to receive Xofigo
  • At least 18 years of age
  • ECOG performance status ≤ 3

Key Exclusion

  • Predominant visceral metastatic disease
  • Prior or concurrent malignancy interfering with safety or efficacy assessment
  • Uncontrolled intercurrent illness
  • Ongoing or active infection
  • Symptomatic congestive heart failure
  • Unstable angina pectoris or cardiac arrhythmia
  • Concurrent alternative radiopharmaceuticals
  • Inability to maintain stationary supine pose for 45-60 minutes

NCT07090148

Pilot Trial of a DNA Vaccine Encoding Prostatic Acid Phosphatase (pTVG-HP) and PD-1 Blockade, With Targeted Ablation of Resistant Lesions, in Patients With Non-Castrate Recurrent Oligometastatic Prostate Cancer

Organization/Sponsor: University of Wisconsin, Madison


Example patient: A 62-year-old man with biochemically recurrent prostate adenocarcinoma after radical prostatectomy, rising PSA with doubling time of 8 months, two bone metastases on PSMA PET/CT, normal testosterone level, ECOG 0, and no prior androgen deprivation therapy.

Phase N/A

Interventions

  • Biological: Anti-PD-1 monoclonal antibody
    Summary: Nivolumab is a PD-1 blocking monoclonal antibody that enhances immune response by preventing PD-1 pathway suppression, approved for multiple cancers but not prostate cancer (FDA label, NCI Thesaurus).
  • Biological: pTVG-HP DNA vaccine
    Summary: A plasmid DNA vaccine encoding prostatic acid phosphatase that stimulates cytotoxic T lymphocyte response against PAP-expressing prostate cancer cells (NCI Thesaurus, Web Search).

Key Inclusion

  • At least 18 years of age with histologic diagnosis of prostate adenocarcinoma
  • Undergone radical prostatectomy with completed local therapy at least 3 months prior
  • Biochemically recurrent disease with positive PSA doubling time from 4 recent values
  • Oligometastatic disease with <3 lesions on CT/bone scan
  • Lesions consistent with metastatic prostate cancer on PSMA PET/CT
  • ECOG performance score <2 and life expectancy at least 12 months
  • Normal hematologic, renal and liver function
  • Serum testosterone at screening not <50 ng/dL

Key Exclusion

  • Small cell or other variant prostate cancer histology
  • Immunosuppression or immunosuppressive therapy within 3 months of first vaccination
  • Seropositive for HIV, hepatitis B or hepatitis C
  • Prior LHRH agonist or antiandrogen except neoadjuvant/adjuvant up to 24 months without PSA progression
  • Serum testosterone <50 ng/dL at screening
  • Concurrent medications with hormonal effects including finasteride, ketoconazole, or Saw Palmetto
  • Previous experimental prostate cancer therapies without 4 week washout
  • Active treatment on other investigational therapeutic studies within 4 weeks

NCT07354919

A Phase II Trial of Cancer Response Using Axelopran in Patients With Advanced Cancers on Opioids (AxeCan)

Organization/Sponsor: HealthPartners Institute


Example patient: A 67-year-old man with metastatic castrate-resistant prostate cancer progressed on enzalutamide and docetaxel, currently taking 10mg oral morphine daily for bone pain, with measurable liver metastases and testosterone level of 15 ng/dL.

Phase II

Interventions

  • Drug: axelopran
    Summary: Axelopran is an investigational agent being studied for cancer control in phase II trials; its specific mechanism of action has not been publicly disclosed but is being evaluated in patients with advanced cancers including breast, prostate, pancreatic, and lung cancers (source: Web Search).

Key Inclusion

  • Histologically or cytologically proven prostate, breast, pancreatic, or NSCLC that has relapsed or progressed after standard systemic treatment including cytotoxic chemotherapy
  • Advanced stage (locally advanced or metastatic) with no definitive plans for curative-intent therapy
  • Current use of opioid medication with average of 5mg OME/day over past 3 days
  • At least one measurable lesion meeting RECIST v1.1 criteria
  • Prostate cancer must be mCRPC progressed on at least one ARPI and docetaxel with testosterone <50 ng/dL
  • Breast cancer must be hormone-refractory with at least one line of systemic cytotoxic chemotherapy
  • Minimum life expectancy of at least 2 months
  • At least 2 weeks since last cancer-directed therapy

Key Exclusion

  • Any previous gastrointestinal surgery except uncomplicated appendectomy or cholecystectomy
  • Active malignancy causing direct extension/invasion of GI tract
  • Current, active, untreated brain metastases
  • History of fecal incontinence, irritable bowel syndrome, inflammatory bowel disease, or intestinal obstruction
  • Use of buprenorphine, alvimopan, naltrexone, methylnaltrexone, naloxone, lubiprostone, linaclotide, or tapentadol within 14 days
  • Receipt of strong CYP3A4 inhibitors or inducers within 14 days or 5 half-lives
  • Receipt of anti-VEGF therapies within 30 days
  • QTc >470 msec or clinically significant abnormal ECG

NCT06705686

Phase 1 First in Human Trial to Assess Safety and Tolerability of the Novel ACK1 Inhibitor (R)-9b in Patients With Prostate Cancer

Organization/Sponsor: TechnoGenesys, Inc.


Example patient: A 67-year-old man with metastatic castration-resistant prostate cancer with bone and lymph node metastases, ECOG 1, castrate testosterone on leuprolide, progressive disease after abiraterone and enzalutamide, no brain metastases or seizure history.

Phase 1

Interventions

  • Drug: (R)-9bMS
    Summary: An orally bioavailable ACK1 inhibitor that blocks androgen receptor expression including AR-v7 splice variant and disrupts ACK1/pY18-CSK signaling to enhance T-cell activation and immune response against prostate cancer tumors (NCI Thesaurus, Web Search).

Key Inclusion

  • Metastatic castration-resistant prostate cancer (mCRPC) with histological or cytological confirmation
  • Evidence of metastatic disease on conventional imaging (CT, MRI, bone scan)
  • Ongoing androgen deprivation therapy or history of surgical castration
  • Castrate testosterone levels ≤50 ng/dL maintained throughout study
  • Progressive disease with PSA rises or radiographic progression
  • Prior progression on at least one novel hormonal agent (enzalutamide, abiraterone, apalutamide, darolutamide)
  • ECOG performance status ≤1
  • Age ≥18 years with adequate organ and bone marrow function

Key Exclusion

  • Small molecule kinase inhibitor within 14 days before study treatment
  • Small cell variant or non-adenocarcinoma prostate cancer histology exclusively
  • Systemic corticosteroids >10 mg daily prednisone equivalent within 14 days
  • Active malignancy or other malignancy requiring treatment within 3 years
  • Anti-androgen receptor agents or abiraterone within 14 days or 5 half-lives
  • Known brain metastases unless treated and stable for ≥4 weeks
  • History of seizures or seizure disorder
  • Cardiovascular disorders including NYHA Class 3-4 heart failure, uncontrolled hypertension, or stroke/MI within 6 months

NCT07145177

A Phase 1b Study of 177Lu-PSMA-617 Combined With Liver Directed Therapy in Metastatic Castration Resistant Prostate Cancer

Organization/Sponsor: University of California, San Francisco


Example patient: A 68-year-old man with metastatic castration-resistant prostate cancer progressing on enzalutamide, with castrate testosterone levels on LHRH therapy, PSMA-avid bone lesions and three liver metastases, ECOG status 1, and adequate organ function.

Phase 1

Interventions

  • Radioligand Therapy: 177Lu-PSMA-617
    Summary: A radioligand therapy targeting PSMA-positive prostate cancer cells, delivering beta-particle radiation from lutetium-177 to destroy cancer cells; used for metastatic castration-resistant prostate cancer (NCI Thesaurus, Web Search).
  • Procedure: Trans-arterial chemoembolization (TACE)
    Summary: A hepatic artery embolization technique delivering chemotherapy directly to liver tumors via arterial supply, combined with embolic agents to starve and kill tumor cells (NCI Thesaurus, Web Search).
  • Procedure: Ablation
    Summary: Uses energy-based methods to destroy cancerous tissue while preserving healthy tissue; includes techniques like radiofrequency and MRI-guided ultrasound ablation (NCI Thesaurus, Web Search).
  • Diagnostic Test: Positron Emission Tomography (PET)/Computerized tomography (CT)
    Summary: Combined imaging technique using PET and CT scans with PSMA radiotracers to detect, stage, and monitor prostate cancer (NCI Thesaurus, Web Search).
  • Procedure: Tumor Biopsy
    Summary: Removal of tissue samples for microscopic examination to diagnose cancer; may use MRI guidance for improved accuracy (NCI Thesaurus, Web Search).
  • Assessment: Questionnaire
    Summary: EORTC QLQ-PR25 questionnaire assessing health-related quality of life in prostate cancer patients through self-reported symptom severity and functional impacts (Web Search, NCI Thesaurus).

Key Inclusion

  • Histologically confirmed prostate cancer with progressive disease by PCWG3 criteria
  • Castrate testosterone level (<50 ng/dL) maintained on LHRH analogue if no orchiectomy
  • Prior progression on at least one second-generation androgen signaling inhibitor (abiraterone, apalutamide, darolutamide, enzalutamide)
  • At least one PSMA-avid extrahepatic lesion on screening PSMA PET
  • One or more liver metastases amenable to liver-directed therapy
  • ECOG performance status ≤2 or Karnofsky ≥50%
  • Adequate organ function including platelets ≥100,000/mcL, hemoglobin >9.0 g/dL, creatinine clearance ≥30 mL/min
  • Availability of archival mCRPC tissue or willingness to undergo fresh biopsy

Key Exclusion

  • De novo small cell neuroendocrine prostate cancer
  • Prior PSMA-directed radioligand treatment
  • More than 2 lines of prior taxane-based chemotherapy in castration-resistant setting
  • Extrahepatic soft tissue lesions that are PSMA PET-negative
  • Previous bilio-enteric anastomosis, biliary stent, or biliary drain through ampulla of Vater
  • Uncontrolled cardiovascular disease including NYHA Class 3-4 heart failure or myocardial infarction within 6 months
  • Active Hepatitis B or C infection unless treated with undetectable viral load
  • Clinically significant ascites requiring more than one paracentesis in 28 days prior to treatment

NCT07393867

Androgen-responsive POSLUMA-guided Intra-prostatic Boost (ARPEGGIO)

Organization/Sponsor: Brigham and Women's Hospital


Example patient: A 65-year-old man with ECOG 0, NCCN high-risk prostate cancer, PI-RADS 5 lesion on recent MRI, concordant PSMA-avid lesion on PET, prostate volume 60 cc, no prior treatment, planned for SBRT with focal boost.

Phase N/A

Interventions

  • Radiation: Stereotactic Body Radiation Therapy (SBRT) +/- focal microboost
    Summary: SBRT delivers high-dose radiation precisely to prostate tumors with optional focal microboost to specific lesions, sparing healthy tissue and reducing side effects (NCI Thesaurus, Web Search).
  • Drug: Androgen Deprivation Therapy (ADT) +/- bicalutamide
    Summary: ADT reduces androgen levels to slow prostate cancer; bicalutamide is a non-steroidal androgen receptor antagonist (50 mg dose) used with LHRH analogs to block testosterone effects (FDA label, NCI Thesaurus).
  • Diagnostic: PSMA PET/CT
    Summary: PSMA PET/CT uses radioactive tracers targeting prostate-specific membrane antigen to detect and stage prostate cancer by imaging cancerous tissues (NCI Thesaurus, Web Search).

Key Inclusion

  • 18 years of age and older
  • ECOG status 0 to 1
  • Histologic diagnosis of prostate cancer
  • PI-RADS 4 or 5 lesion on MRI within 180 days
  • NCCN intermediate-risk or high-risk prostate cancer
  • PSMA PET scan with focal avid lesion concordant with MRI within 180 days
  • Intention for SBRT 36.25 Gy/5 fractions with focal boost up to 50 Gy

Key Exclusion

  • Prior imaging showing nodal or distant disease
  • Intention for treatment intensification with secondary androgen receptor inhibitors or chemotherapy
  • Clinical T4 disease
  • Prior ADT or pelvic radiation therapy
  • Prior prostate surgery including TURP
  • International prostate symptom score greater than 20
  • Prostate volume greater than 80 cc on MRI
  • Active Crohn's disease or scleroderma

NCT07048314

A Randomized Clinical Trial to Assess Safety and Efficacy of Allogeneic Adipose-derived Mesenchymal Stem Cells in Promoting the Recovery of Erectile Function Post Radical Retropubic Prostatectomy of Localized Prostate Cancer

Organization/Sponsor: The Methodist Hospital Research Institute


Example patient: A 58-year-old man with clinical stage T1c prostate cancer, Gleason score 6, testosterone 450ng/dl, IIEF-5 score of 22, scheduled for robotic-assisted laparoscopic prostatectomy with a supportive partner and no history of penile abnormalities or hormonal therapy.

Phase N/A

Interventions

  • Placebo: Placebo in clinic
    Summary: Saline solution used as an inactive placebo control to provide baseline measurements for the experimental protocol (NCI Thesaurus, FDA label).
  • Placebo: Placebo in the OR
    Summary: Saline solution administered in the operating room as an inactive placebo control for baseline comparison (NCI Thesaurus, FDA label).
  • Biological: Allogeneic adipose-derived mesenchymal stem cells (HB-adMSCs) in the OR
    Summary: Culture-expanded human allogeneic adipose-derived MSCs that are pluripotent and capable of differentiating into functional cells to restore tissue function damaged by therapy (NCI Thesaurus).
  • Biological: Allogeneic adipose-derived mesenchymal stem cells (HB-adMSCs) at the doctor's office
    Summary: Allogeneic adipose-derived MSCs administered to modulate immune responses and potentially restore tissue function through pluripotent differentiation into functional cells (NCI Thesaurus, Web Search Summary).

Key Inclusion

  • Patients scheduled for RALP with Dr. B. Miles at Houston Methodist
  • Men aged between 40 and 70 years old
  • Localized prostate cancer: Clinical stage T1-T2, N0, M0
  • Gleason score < 7
  • Pre-op IIEF-5 >20
  • Testosterone serum > 300ng/dl with normal Free Testosterone
  • Life expectancy of at least 10 years
  • Willing to attempt intercourse at least 5 times per month following urinary control after surgery

Key Exclusion

  • Penile anatomical abnormalities (Peyronie's disease)
  • Hypogonadism
  • Any medication used for androgen ablation
  • AST levels above 40U/L; ALT levels above 33 U/L and Glucose levels above 180 mg/dl
  • Previous or current hormonal treatment, chemotherapy, radiation therapy, immunotherapy or another investigational drug
  • Any previous penile implant or penile vascular surgery
  • Injections of Trimix pre and post-surgery

NCT07234981

PSMA-PET Guided De-escalation of Salvage Radiation Treatment in Patients With Recurrent Prostate Cancer After Prostatectomy

Organization/Sponsor: University of Nebraska


Example patient: A 58-year-old man with biochemical recurrence (PSA 0.3 ng/mL) two years after radical prostatectomy, PSMA-PET showing isolated prostate bed lesion, ECOG 1, no metastases or contraindications to radiation.

Phase N/A

Interventions

  • Radiation: PSMA-guided Salvage Radiation
    Summary: PSMA-guided salvage radiation targets prostate cancer recurrence after surgery using PSMA-PET scans to precisely deliver radiation, aiming to improve cancer control and reduce side effects (Source: Web Search).

Key Inclusion

  • Prior radical prostatectomy with curative intent for prostate cancer
  • Biochemical recurrence per NCCN criteria (PSA >0.1 ng/mL or rising PSA)
  • PSMA-avid lesion in prostate bed or pelvic lymph nodes or MRI-defined prostate bed lesion
  • Life expectancy greater than 5 years
  • Karnofsky performance status ≥80 or ECOG ≤2
  • Age ≥30 years

Key Exclusion

  • Distant metastatic disease outside pelvic lymph nodes
  • Osseous pelvic disease
  • Psychological, familial, sociological, or geographical conditions hampering compliance
  • Alcohol dependence or drug abuse
  • Contraindications to radiation therapy
  • Inflammatory bowel disease
  • Connective tissue disorders (lupus, scleroderma)
  • Genetic disorders with increased radiation sensitivity

NCT06024772

Prostate Cancer Diagnosis by Multiparametric Ultrasound (Clinical)

Organization/Sponsor: Thomas Jefferson University


Example patient: A 62-year-old male with PSA of 5.2 ng/ml and no prior prostate cancer treatment scheduled for diagnostic biopsy with contrast-enhanced ultrasound imaging.

Phase N/A

Interventions

  • Procedure: Biopsy of Prostate
    Summary: Removes tissue samples from the prostate to detect cancer by targeting suspicious areas or multiple regions for microscopic examination (NCI Thesaurus, Web Search).
  • Procedure: Transrectal Ultrasound
    Summary: Uses sound waves via a rectal probe to create video images of pelvic organs, primarily to evaluate the prostate gland (NCI Thesaurus).
  • Drug: Perflutren lipid microsphere
    Summary: Injectable ultrasound contrast agent containing perflutren gas in lipid microspheres that scatter ultrasound waves at the blood interface to enhance imaging visualization (FDA label, NCI Thesaurus).
  • Procedure: Multiparametric Magnetic Resonance Imaging
    Summary: Advanced MR imaging combining techniques like diffusion, perfusion, and spectroscopy to enhance diagnostic power beyond conventional contrast-enhanced MRI (NCI Thesaurus).

Key Inclusion

  • Scheduled for prostate biopsy
  • Elevated PSA greater than 3.0 ng/ml
  • Elevated PSA velocity greater than 0.75 ng/ml/year
  • Abnormal digital rectal examination
  • Male at least 18 years of age
  • Able to give written informed consent

Key Exclusion

  • Participant in investigational drug trial within past 30 days
  • Hypersensitivity to perflutren or polyethylene glycol
  • Hypersensitivity to any component of Definity
  • Previous treatment for prostate cancer including hormone therapy
  • Clinically unstable or severely ill

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 67-year-old male with metastatic castration-resistant prostate adenocarcinoma on continuous androgen deprivation therapy for 18 months with testosterone 25 ng/dL, ECOG 1, measurable liver metastases, and no prior sipuleucel-T or lutetium therapy.

Phase N/A

Interventions

  • Drug: Lutetium Lu 177 Vipivotide Tetraxetan
    Summary: Radioligand therapy targeting PSMA-positive prostate cancer cells, delivering radiation to shrink tumors in metastatic castration-resistant prostate cancer; side effects include fatigue and bone marrow suppression (Summary of Web Search).
  • Biological: Sipuleucel-T
    Summary: Autologous dendritic cell immunotherapy loaded with prostate-specific antigen to stimulate immune response against cancer cells; FDA-approved in 2010 for metastatic castration-resistant prostate cancer (Summary of Web Search).
  • Procedure: Leukapheresis
    Summary: Procedure to collect white blood cells from peripheral blood for treatment preparation, filtering blood to separate leukocytes while returning remaining components to donor (NCI Thesaurus, Summary of Web Search).
  • Diagnostic: PSMA PET Scan
    Summary: Imaging technique targeting prostate-specific membrane antigen to detect prostate cancer, improving detection of recurrence and staging in advanced prostate cancer (Summary of Web Search).
  • Diagnostic: Magnetic Resonance Imaging
    Summary: Noninvasive imaging using radiofrequency waves and magnetic fields to provide detailed pictures of internal organs and tissues for cancer diagnosis and monitoring (NCI Thesaurus).
  • Diagnostic: Computed Tomography
    Summary: X-ray imaging method using computer reconstruction to create cross-sectional scans for detecting cancer spread and monitoring tumor progression (NCI Thesaurus, Summary of Web Search).
  • Diagnostic: Bone Scan
    Summary: Nuclear imaging using technetium-99m to evaluate pathological bone metabolism and identify bone metastases by highlighting areas of increased bone activity (NCI Thesaurus, Summary of Web Search).
  • Procedure: Biospecimen Collection
    Summary: Gathering tissue and fluid samples for testing and research to analyze genetic and molecular features for understanding cancer mechanisms and developing targeted therapies (NCI Thesaurus, Summary of Web Search).

Key Inclusion

  • Progressive castration-resistant metastatic prostate cancer with adenocarcinoma pathology without small cell features
  • Androgen deprivation therapy for at least 3 months with castrate testosterone <50 ng/dL
  • Measurable disease ≥10 mm (visceral) or lymph nodes ≥20 mm, or non-measurable bone lesions
  • ECOG performance status ≤1
  • Age ≥18 years, male
  • Adequate hematologic function: ANC ≥1500/mm³, platelets ≥100,000/mm³, hemoglobin ≥9 g/dL
  • Adequate organ function: bilirubin ≤1.5x ULN, AST ≤2.5x ULN, creatinine ≤1.5x ULN
  • Seronegative for HIV, HCV, HBV, and syphilis or undetectable viral load

Key Exclusion

  • Prior treatment with 177Lu-PSMA-617 or sipuleucel-T
  • Anticancer therapy including chemotherapy, hormonal therapy, or radiotherapy within 4 weeks
  • Systemic corticosteroids, ketoconazole, 5-alpha-reductase inhibitors, or PC-SPES within 28 days
  • Treatment with investigational vaccine within 2 years or other investigational product within 28 days
  • 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 active hepatitis or cirrhosis
  • Radiation therapy for bone metastasis within 2 weeks or other radiation within 4 weeks

NCT07424547

Phase I Dose Escalation and Cohort Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SYS6043 in Patients With Advanced/Metastatic Solid Tumors

Organization/Sponsor: Conjupro Biotherapeutics, Inc.


Example patient: A 62-year-old man with metastatic castration-resistant prostate cancer progressing after standard therapies, ECOG 1, with bone and lymph node metastases, normal cardiac function, and no prior B7-H3 targeted treatment.

Phase I

Interventions

  • Drug: SYS6043
    Summary: SYS6043 is an antibody-drug conjugate targeting B7-H3, a protein expressed in certain advanced tumors, delivering a cytotoxic payload to cancer cells expressing B7-H3 for treatment of advanced or metastatic solid tumors including breast cancer (Source: Web Search).

Key Inclusion

  • Aged ≥18 years old
  • Advanced/unresectable or metastatic solid tumors confirmed by histology or cytology
  • Disease recurrence or progression during or after standard of care
  • At least one measurable lesion per RECIST V1.1
  • Life expectancy ≥3 months
  • ECOG performance status 0-1
  • LVEF ≥50% by ECHO or MUGA

Key Exclusion

  • Prior B7-H3 targeted therapy
  • Previously received topoisomerase inhibitor antibody-drug conjugate
  • Symptomatic congestive heart failure (NYHA Class II-IV)
  • Myocardial infarction or unstable angina within 6 months
  • Mean QTcF >470 ms
  • History of interstitial lung disease or non-infectious pneumonia
  • Active clinically significant bacterial, fungal, or viral infection
  • Spinal cord compression or clinically active brain metastasis

NCT07540572

An Open Label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of IDE574 as Monotherapy in Locally Advanced or Metastatic Solid Tumors and as Combination Therapy With Fulvestrant in Locally Advanced or Metastatic ER+, HER2- Breast Cancer

Organization/Sponsor: IDEAYA Biosciences


Example patient: A 62-year-old postmenopausal woman with metastatic ER+, HER2- breast cancer who progressed after treatment with letrozole and palbociclib, ECOG PS 1, with adequate organ function and no brain metastases.

Phase 1

Interventions

  • Drug: IDE574
    Summary: IDE574 is a dual inhibitor of KAT6/7 enzymes that blocks specific histone acetyltransferases to inhibit cancer growth in breast cancer and other solid tumors, currently in Phase 1 trials (Web Search).
  • Drug: Fulvestrant injection
    Summary: Fulvestrant is an estrogen receptor antagonist that degrades estrogen receptors to block estrogen signaling in hormone receptor-positive, HER2-negative advanced breast cancer, administered via intramuscular injection (FDA label).

Key Inclusion

  • Advanced or metastatic ER+, HER2- breast cancer, NSCLC, CRPC, or MSS colorectal adenocarcinoma
  • Progressed on/after at least one line of standard therapy or intolerant to additional effective therapies
  • ER+, HER2- breast cancer progressed after at least 1 prior endocrine therapy and CDK4/6 inhibitor
  • ECOG performance status ≤1
  • Adequate bone marrow, renal and liver function
  • Life expectancy >3 months
  • Archival tissue sample available for testing
  • Able to retain orally administered study treatment

Key Exclusion

  • Known symptomatic brain metastases or leptomeningeal metastasis
  • Known primary CNS malignancy or other malignancies within 2 years
  • Impairment of GI function that may alter absorption of IDE574
  • Active liver or biliary disease
  • Active, uncontrolled bacterial, fungal, or viral infection
  • Clinically significant cardiac abnormalities or blood clotting events within 6 months
  • Prior irradiation to >25% of bone marrow
  • Known or suspected hypersensitivity to IDE574, fulvestrant, or their excipients