Sophic Logo gordian knotProstate Cancer Clinical Trials Intelligence

Monthly Update Report for Trials Started in August 2026


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


Overview

Number of Trials: 22

The 22 trials focus predominantly on prostate cancer, spanning treatment de-escalation, novel ADCs, radioligand therapy, imaging diagnostics, exercise and lifestyle interventions, and supportive care. Several trials investigate advanced/metastatic castration-resistant prostate cancer using targeted agents like ARPIs, PSMA-based radiotherapeutics, and novel degraders. Others address survivorship, sexual health, genetic education, and quality of life.

Common Criteria Across Trials

Common Inclusion

  • Histologically confirmed prostate cancer/adenocarcinoma
  • Adult males aged 18+
  • ECOG performance status 0-2
  • Adequate organ/marrow function
  • Ongoing or prior androgen deprivation therapy (ADT)
  • Ability to provide informed consent
  • Willingness to comply with study procedures

Common Exclusion

  • Known CNS/brain metastases or leptomeningeal disease
  • Significant uncontrolled cardiovascular disease
  • Recent major surgery or radiotherapy
  • Prior use of specific investigational or overlapping therapies
  • Active uncontrolled infections (HIV, HBV, HCV) unless controlled
  • Other active malignancies within past 2-3 years
  • Inability to swallow oral medications

Outcomes Summary

Primary Outcomes

Secondary Outcomes


2: Extracted Trials with New Information


Trials with Special Criteria

Genomic / Biomarker Trials

Unique or Unusual Criteria


3: Individual Trial Overviews


NCT07645326

A Pragmatic Phase 2 Trial of Risk-Adapted Treatment Approaches Including Treatment De-escalation to Minimize Adverse Effects of Hormonal Therapy in Metastatic Hormone-Sensitive Prostate Cancer.

Organization/Sponsor: Georgetown University


Example patient: A 68-year-old man newly diagnosed with high-risk metastatic castrate-sensitive prostate cancer, started on ADT and ARPI six weeks ago, with no prior chemotherapy, radiopharmaceuticals, or leptomeningeal disease, willing to follow the study protocol.

Phase 2

Interventions

  • Chemotherapy: Docetaxel
    Summary: Microtubule inhibitor taxane that stabilizes tubulin, causing G2/M arrest and cell death; used in high-risk mCSPC combined with ADT/ARPI. Source: FDA label, NCI Thesaurus.
  • Radiation: Prostate Radiation
    Summary: Radiotherapy directed at the prostate to kill localized cancer cells as part of low-risk standard-of-care regimen. Source: Summary of Web Search.
  • Hormonal Therapy: Androgen Receptor Pathway Inhibitor (ARPI)
    Summary: Blocks androgen receptor signaling (e.g., enzalutamide, apalutamide, darolutamide) to inhibit prostate cancer cell growth. Source: Summary of Web Search.
  • Hormonal Therapy: Androgen Deprivation Therapy (ADT)
    Summary: Reduces serum testosterone via GnRH agonists/antagonists to slow androgen-driven prostate cancer growth; backbone therapy in both risk arms. Source: FDA label, NCI Thesaurus.

Key Inclusion

  • Adult with metastatic castrate sensitive prostate cancer
  • Eligible for SOC per treating physician
  • Low risk: ADT + ARPI + prostate radiation
  • High risk: ADT + ARPI +/- docetaxel
  • Prior ADT/ARPI up to 8 weeks permitted
  • Able to give informed consent and comply with follow-up

Key Exclusion

  • Prior chemotherapy other than docetaxel for prostate cancer
  • Prior radiopharmaceuticals for prostate cancer
  • Radiotherapy within 2 weeks before study start
  • ARPI for non-metastatic disease within 6 months of metastatic diagnosis
  • Recent participation in another investigational drug study
  • Inability to swallow oral medications
  • Leptomeningeal disease

NCT07746414

Effects of High Intensity Interval Training Among Patients With Prostate Cancer Prior to Radical Prostatectomy

Organization/Sponsor: Yale University


Example patient: A 62-year-old man with newly diagnosed intermediate-risk, clinically localized prostate cancer scheduled for radical prostatectomy, sedentary, medically stable, and able to attend twice-weekly exercise sessions.

Phase N/A

Interventions

  • Behavioral/Exercise: High-intensity interval training (HIIT) exercise
    Summary: HIIT alternates intense anaerobic bursts with recovery periods; may inhibit cancer cell growth, lower PSA, and improve metabolic health prior to surgery. Source: NCI Thesaurus, Summary of Web Search.

Key Inclusion

  • Scheduled radical prostatectomy at Yale New Haven Hospital
  • English language fluency
  • Clinically localized low, intermediate, or high risk (NCCN)
  • Able to attend 2 in-person exercise sessions/week for 4-6 weeks

Key Exclusion

  • Treatment with non-surgical modality
  • Prior therapy for prostate cancer
  • Already exercising regularly (>60 min/week)
  • Unstable cardiovascular disease
  • Physical mobility limitation
  • Locally advanced (cT4, cN1, cM1) disease
  • Prior androgen deprivation therapy

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 newly diagnosed metastatic prostate cancer and hypertension is starting ARPI therapy planned for 18 months, with no prior cardio-oncology care.

Phase N/A

Interventions

  • Procedure/Communication: Notification to PCP/General Cardiologist
    Summary: Communication intervention notifying primary care/cardiology providers of cardiovascular risk in ARPI-treated prostate cancer patients to improve care coordination. Source: Summary of Web Search.
  • Procedure/Referral: Cardio-Oncology Referral
    Summary: Referral to a cardio-oncology specialist aimed at early cardiovascular risk management in prostate cancer patients on ARPI therapy, potentially reducing cardiotoxic effects. Sources: Summary of Web Search; NCI Thesaurus.

Key Inclusion

  • Localized very-high risk, node-positive, or metastatic (Stage IV) prostate cancer
  • Planned ARPI therapy duration ≥18 months
  • Age >65 with ≥1 CV risk factor, or age 45-65 with ≥2 CV risk factors
  • Hypertension, hyperlipidemia, diabetes, or family history of early CAD
  • Presence of coronary artery calcium on CT
  • ECOG performance status 0-2
  • Able to provide informed consent

Key Exclusion

  • Prior ARPI therapy exposure >6 months
  • Already established care with a cardio-oncologist

NCT07639086

Sacituzumab Tirumotecan in Patients With Neuroendocrine Prostate Cancer After Progression on Prior Chemotherapy

Organization/Sponsor: Virginia Commonwealth University


Example patient: A 65-year-old man with treatment-related neuroendocrine prostate cancer, previously treated with ADT and platinum-based chemotherapy, now progressing with measurable bone metastases, ECOG 1, and normal organ function, without CNS involvement or prior ADC therapy.

Phase N/A

Interventions

  • Antibody-drug conjugate: Sacituzumab Tirumotecan
    Summary: ADC targeting TROP2-expressing tumor cells, delivering a topoisomerase I inhibitor payload (tirumotecan) causing DNA damage and apoptosis; being studied for neuroendocrine prostate cancer after platinum-based chemo failure. Source: NCI Thesaurus, FDA label, Web Search.

Key Inclusion

  • Confirmed de novo or treatment-related neuroendocrine prostate cancer (NEPC)
  • Progressed after at least one course of platinum-based chemotherapy
  • Measurable metastatic disease per PCWG modified RECIST 1.1
  • Male, age ≥18
  • Archival or recent tumor tissue sample available
  • Adequate organ function (ANC, platelets, hemoglobin, renal, hepatic)
  • ECOG performance status 0-1
  • Controlled HIV/HBV/HCV allowed under specific conditions

Key Exclusion

  • Prior TROP2-targeted ADC or topoisomerase 1 inhibitor ADC treatment
  • Uncontrolled cardiovascular or cerebrovascular disease
  • Active CNS metastases or carcinomatous meningitis
  • Severe dry eye, corneal, or Meibomian gland disease
  • History of pneumonitis/interstitial lung disease
  • Recent major surgery or investigational therapy
  • Superscan bone scan
  • Another active malignancy requiring treatment

NCT07618520

Expanding Genetic Access and Guided Education for Prostate Cancer Survivors Genomic-based

Organization/Sponsor: Georgetown University


Example patient: A 65-year-old English-speaking man diagnosed with prostate cancer 8 months ago, who meets NCCN germline testing criteria, has never had genetic testing, and uses a smartphone with internet access.

Phase N/A

Interventions

  • Behavioral/Control: Enhanced Usual Care
    Summary: Standard care control arm without targeted genetic education; used as comparator to evaluate novel educational interventions. Source: Summary of Web Search.
  • Behavioral/Educational: Digital Guide Genetic Education Guide
    Summary: Digital educational tool explaining germline and somatic genetic testing to help prostate cancer patients understand testing benefits and clinical trial eligibility. Source: Summary of Web Search.
  • Behavioral/Educational: Print Genetic Education Guide
    Summary: Printed educational guide for prostate cancer survivors to improve understanding of genetic testing and encourage testing requests, part of ENGAGE Trial. Source: Summary of Web Search.

Key Inclusion

  • 18-80 years of age
  • At least 6 months post prostate cancer diagnosis
  • No prior genetic testing for hereditary cancer
  • Received care at participating site in prior 5 years
  • Meets NCCN criteria for germline genetic testing
  • Able to read and speak English
  • Capable of providing informed consent
  • Has internet access and comfortable using digital devices

Key Exclusion

  • Does not speak English
  • Unable to access the Internet
  • Previously underwent germline genetic testing or declined testing after counseling
  • Unable to provide informed consent

NCT07075705

Investigating the Feasibility of Using Transperineal Micro-Ultrasound to Detect Clinically Significant Prostate Cancer

Organization/Sponsor: Roswell Park Cancer Institute


Example patient: A 62-year-old man scheduled for a transrectal ultrasound-guided prostate biopsy who has already completed a prebiopsy MRI and provided informed consent.

Phase N/A

Interventions

  • Diagnostic Imaging: Magnetic Resonance Imaging
    Summary: Noninvasive imaging using radiofrequency waves and a strong magnetic field to detect prostate cancer prior to biopsy. Source: NCI Thesaurus.
  • Diagnostic Imaging: Micro-ultrasound Imaging
    Summary: High-resolution 29 MHz ultrasound providing 70-micron resolution images of prostate tissue, offering a cost-effective alternative to MRI for detecting clinically significant cancer. Source: Summary of Web Search, NCI Thesaurus.
  • Diagnostic Procedure: Biopsy of Prostate
    Summary: Transrectal ultrasound-guided removal of prostate tissue samples for microscopic examination to confirm cancer diagnosis. Source: NCI Thesaurus.

Key Inclusion

  • Men aged ≥ 18 years
  • Scheduled for transrectal ultrasound guided prostate biopsy
  • Must have had a prebiopsy MRI
  • Able to provide informed consent

Key Exclusion

  • Contraindications to MRI or unwilling to undergo MRI
  • Any condition deemed unsuitable by investigator for study participation

NCT07746713

A Phase 1 Trial of JNJ-98768111, an Antibody Drug Conjugate (ADC) Targeting Human Kallikrein-2 (KLK2) for Advanced Prostate Cancer

Organization/Sponsor: Janssen Research & Development, LLC


Example patient: A 68-year-old man with metastatic castration-resistant prostate cancer, prior enzalutamide treatment, PSA of 15 ng/mL, ECOG 1, and no CNS metastases or recent cardiovascular events, seeking a new treatment option.

Phase 1

Interventions

  • Drug: JNJ-98768111
    Summary: Experimental antibody-drug conjugate targeting human kallikrein-2 (KLK2), delivering cytotoxic payload to prostate cancer cells; under investigation for safety and efficacy in advanced prostate cancer. Source: Summary of Web Search.

Key Inclusion

  • Histologically confirmed prostate adenocarcinoma (including small cell/neuroendocrine features)
  • Measurable or evaluable metastatic disease
  • Prior treatment with at least 1 novel AR-targeted therapy
  • Serum PSA >= 2 ng/mL
  • Prior orchiectomy or ongoing ADT with castrate testosterone levels
  • Progressive metastatic disease after most recent therapy
  • ECOG performance status 0 or 1
  • Agreement to contraception and reproductive precautions

Key Exclusion

  • Active CNS involvement
  • Unresolved toxicity from prior therapy (>Grade 1)
  • External beam radiation to soft tissue within 14 days of trial start
  • Clinically significant cardiovascular disease within 6 months
  • History of solid organ or bone marrow transplantation

NCT07569926

The Impact of Fluciclovine (18F) PET on the Management of Participants With Prostate Cancer Following Negative or Equivocal PSMA PET Imaging at the Time of Biochemical Recurrence

Organization/Sponsor: Blue Earth Diagnostics


Example patient: A 68-year-old man post-radical prostatectomy with PSA rising to 0.3 ng/mL and a negative PSMA PET scan, otherwise healthy and untreated for recurrence, consents to undergo fluciclovine PET imaging.

Phase N/A

Interventions

  • Diagnostic Radiotracer: fluciclovine (18F)
    Summary: Radioactive diagnostic PET imaging agent targeting upregulated amino acid transporters in prostate cancer cells, used to detect biochemical recurrence after negative/equivocal PSMA PET scans. Source: Summary of Web Search.

Key Inclusion

  • Male, age ≥18 years
  • Suspected biochemical recurrence with negative/equivocal PSMA PET scan within 45 days
  • Post-prostatectomy PSA ≥0.2 ng/mL
  • Post-radiation PSA rise ≥2.0 ng/mL above nadir, confirmed
  • Willing to use contraception if sexually active with WOCBP
  • Able to provide informed consent
  • Able to comply with study procedures

Key Exclusion

  • Known metastatic castrate-resistant prostate cancer
  • Medical condition compromising data integrity
  • Planned contrast agent or other PET tracer near scan
  • Recent participation in interventional trial
  • Known hypersensitivity to fluciclovine (18F)
  • Received salvage therapy for current BCR episode
  • Initiated cancer treatment or supplements between PSMA and fluciclovine scans

NCT07745361

MODeFIRe-1 (Molecular Degrader for Inhibitor Resistance): A Phase 2, Open-Label, Multicenter Study of Oral MRT-2359 in Combination With Apalutamide in Patients With Castration-Resistant Prostate Cancer Genomic-based

Organization/Sponsor: Monte Rosa Therapeutics, Inc


Example patient: A 68-year-old man with AR-mutated castration-resistant prostate cancer, prior ARPi and one taxane regimen, testosterone <50 ng/dL, and no CNS or cardiac disease, eligible for MRT-2359 plus apalutamide.

Phase 2

Interventions

  • Drug: Apalutamide
    Summary: Androgen receptor inhibitor that blocks androgen-driven transcription, slowing prostate cancer cell proliferation; approved for castration-resistant/sensitive prostate cancer. Source: FDA label, NCI Thesaurus.
  • Drug: Oral MRT-2359
    Summary: Orally bioavailable molecular glue degrader targeting GSPT1 via CRBN, downregulating MYC-driven protein translation to inhibit tumor growth. Source: NCI Thesaurus, Web Search.

Key Inclusion

  • Age > 18 years
  • Life expectancy ≥3 months, ECOG ≤1
  • Castration-resistant prostate adenocarcinoma with AR mutations
  • ≤1 prior taxane-based chemotherapy regimen
  • No prior AR degrader or opevesostat therapy
  • Testosterone <50 ng/dL
  • Prior ARPi treatment (≥1 line)
  • Measurable disease per PCWG4 criteria

Key Exclusion

  • Prior chemo/radiation/biologic therapy within 21 days
  • Prior GSPT1 degrader discontinued due to AE
  • Recent auto-HCT without full recovery
  • Allogeneic HCT within 6 months or active GVHD
  • Chronic systemic steroid use above replacement dose
  • Active CNS involvement or carcinomatous meningitis
  • History of noninfectious pneumonitis requiring steroids
  • Clinically significant cardiac disease

NCT07723248

A Phase 3, Randomized, Open-Label Study of Rinzimetostat (ORIC-944) in Combination With Darolutamide Compared With ARPI or Docetaxel in Patients With Metastatic Castration Resistant Prostate Cancer Previously Treated With Abiraterone Acetate (Himalayas-1)

Organization/Sponsor: ORIC Pharmaceuticals


Example patient: A 68-year-old man with metastatic castration-resistant prostate cancer, ECOG 1, whose disease progressed on abiraterone in the mCRPC setting, with bone metastases and no prior chemotherapy, ARPIs, or brain metastases.

Phase 3

Interventions

  • Chemotherapy: Docetaxel
    Summary: Microtubule inhibitor taxane that stabilizes tubulin causing cell-cycle arrest and death; used as comparator arm in mCRPC. Source: FDA label, NCI Thesaurus.
  • Androgen receptor pathway inhibitor: Enzalutamide
    Summary: Nonsteroidal androgen receptor antagonist blocking AR signaling to reduce prostate cancer cell proliferation; used as comparator ARPI. Source: FDA label, NCI Thesaurus.
  • Androgen receptor pathway inhibitor: Darolutamide
    Summary: AR antagonist preventing nuclear translocation and transcription of AR-responsive genes, given in combination with rinzimetostat as investigational arm. Source: FDA label, NCI Thesaurus.
  • Investigational small molecule (PRC2 inhibitor): Rinzimetostat
    Summary: Selective allosteric PRC2 inhibitor targeting EED subunit, active even against EZH1-overexpressing cells, combined with darolutamide in mCRPC. Source: Summary of Web Search.

Key Inclusion

  • Histologically confirmed prostate adenocarcinoma without small cell features
  • Progression on abiraterone acetate in mCSPC or first-line mCRPC setting
  • Metastatic disease documented in bone or soft tissue
  • ECOG performance status 0 or 1
  • Adequate organ function

Key Exclusion

  • Prior chemotherapy, radioligand therapy, ARPIs (apalutamide, darolutamide, enzalutamide), PARP inhibitors, or other systemic anticancer treatment (with limited exceptions)
  • Anticancer therapy within 28 days or 5 half-lives before randomization
  • Known or suspected brain metastasis or leptomeningeal disease
  • Clinically significant cardiovascular disease
  • Active/serious infection, psychiatric condition, or suicidal ideation risk
  • Active inflammatory GI disease, chronic diarrhea, or prior gastric resection/lap-band surgery

NCT06811454

A Daily, Digital Mindfulness-Based Intervention for Depressive Symptoms After Serious Medical Illness

Organization/Sponsor: Case Comprehensive Cancer Center


Example patient: A 62-year-old man with stage II prostate cancer, treated 1 year ago, reporting mild depressive symptoms (PHQ-9 score of 10), no suicidal ideation, and no prior mindfulness training, who owns a smartphone.

Phase N/A

Interventions

  • Behavioral: Enhanced Usual Care (EUC)
    Summary: Standard supportive care without added mindfulness training, used as a control condition to compare against the digital intervention; lacks specific therapeutic mechanism beyond usual practice. Source: Summary of Web Search.
  • Behavioral/Digital: MINDSET
    Summary: Digital mindset-based intervention encouraging adaptive beliefs about cancer and bodily capability to reduce depressive symptoms via cognitive-emotional reframing. Sources: Summary of Web Search, NCI Thesaurus.

Key Inclusion

  • PHQ-9 score 5-19 (mild-moderate depression)
  • Stage 0-III breast, prostate, or colorectal cancer
  • Completed primary treatment within 2 years (excluding hormone therapy)
  • Able to give informed consent
  • English literacy
  • Access to web-enabled device

Key Exclusion

  • PHQ-9 <4 or >20
  • Suicidal ideation (item 9 >1)
  • Severe psychiatric/medical condition needing priority care
  • Current substance abuse
  • Stage IV cancer
  • Active cancer recurrence requiring treatment
  • Current mindfulness practice
  • Prior formal mindfulness program participation

NCT07655557

Pilot Testing a Sexual Health Communication Skills Training Intervention for Patients With Prostate Cancer

Organization/Sponsor: NYU Langone Health


Example patient: A 62-year-old English-speaking man in the U.S. with prostate cancer, bothered by sexual dysfunction, has internet access and an upcoming NYU Langone appointment, and consents to participate.

Phase N/A

Interventions

  • Behavioral: Time and Attention
    Summary: Supportive control intervention providing psychological attention without targeting sexual health communication; not prostate cancer-specific mechanistically. Source: Summary of Web Search.
  • Behavioral: Starting the Conversation (STC)
    Summary: Communication skills training using a slideshow, workbook, and resource guide to boost self-efficacy and provider discussions about sexual dysfunction in prostate cancer patients. Source: Summary of Web Search.

Key Inclusion

  • Adult male with prostate cancer, 18+ years
  • English speaking
  • Resides in the U.S.
  • Has internet/web access
  • Reports current bother due to sexual dysfunction
  • Capacity and willingness to consent
  • Has appointment with PCa provider at NYU Langone during accrual period

Key Exclusion

  • Impaired decision-making capacity
  • Already participating in another part of this study (prior aim)

NCT07635524

A Two Center Phase 2 Trial of 61Cu-noDAGa-PSMA I&T (61Cu-NU101) for Patients With Prostate Cancer

Organization/Sponsor: Hoag Memorial Hospital Presbyterian


Example patient: A 68-year-old man with biopsy-confirmed prostate adenocarcinoma, ECOG 0, and 3 PSMA-avid metastatic sites on recent 18F-piflufolastat PET/CT, with no other cancers or imaging agent allergies.

Phase 2

Interventions

  • Diagnostic Imaging Agent: Cu-NU101
    Summary: Cu-NU101 is a PSMA-targeted PET imaging agent labeled with Copper-61, used to detect PSMA-positive prostate cancer lesions with improved sensitivity and prolonged imaging window due to isotope half-life. Source: Summary of Web Search.

Key Inclusion

  • Biopsy proven prostate adenocarcinoma
  • Age >= 18 years
  • ECOG 0 or 2
  • Oligometastatic disease (1-5 radiotracer avid sites)
  • Positive 18F-piflufolastat PET/CT within 30 days

Key Exclusion

  • Allergy/hypersensitivity to PSMA-targeted imaging agents
  • Other active malignancy besides prostate cancer

NCT07550517

A Phase II Non-blinded Randomized Study Comparing External Beam Radiotherapy (EBRT), 177Lu-PSMA-617, and Short Term Androgen Deprivation Therapy (ADT) Versus EBRT and Long Term ADT in Men With High Risk Localized Prostate Cancer

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


Example patient: A 66-year-old man with newly diagnosed Grade Group 4 localized prostate cancer, PSA 25 ng/mL, PSMA-PET SUVmax 12, no nodal or metastatic disease, and normal organ function, eligible for EBRT with ADT and no prior cancer treatment.

Phase 2

Interventions

  • Radiotherapy + Hormone Therapy: EBRT + 24 mo ADT
    Summary: Combines external beam radiotherapy with 24 months of androgen deprivation therapy to reduce tumor burden and androgen signaling in high-risk localized prostate cancer. Source: Summary of Web Search.
  • Radiotherapy + Hormone Therapy + Radioligand Therapy: EBRT + 6 mo ADT + 177Lu-PSMA-617
    Summary: Combines EBRT and 6 months ADT with 177Lu-PSMA-617, a PSMA-targeting radioligand that delivers beta-particle radiation to PSMA-expressing prostate cancer cells, inducing targeted cell death. Source: Summary of Web Search; NCI Thesaurus.

Key Inclusion

  • High-risk localized prostate cancer (cT3a, Grade Group 4-5, or PSA >20)
  • Histologic adenocarcinoma of prostate
  • No N1 disease by conventional imaging
  • PSMA-PET SUVmax >10
  • Eligible for EBRT and ADT (≤45 days prior ADT allowed)
  • Age ≥18 years, ECOG ≤2
  • Adequate bone marrow, renal, and liver function
  • Life expectancy ≥24 months

Key Exclusion

  • Very high-risk features (cT3b-T4, pattern 5, multiple high-risk features)
  • Prior prostate cancer therapy or pelvic radiation
  • N1 or M1 disease by imaging
  • Castration-resistant prostate cancer
  • Concurrent investigational or anti-cancer treatment
  • Inadequate organ or marrow function
  • Inflammatory bowel disease or pelvic radiation contraindication
  • Inability to tolerate imaging or EBRT positioning

NCT07518888

Exercise-induced Steroid Changes in Active Surveillance for Prostate Cancer

Organization/Sponsor: University of Miami


Example patient: A 65-year-old man with localized prostate cancer under active surveillance, physically active, in good cardiovascular health, and fluent in English, agrees to participate in the HIIT exercise study.

Phase N/A

Interventions

  • Behavioral/Exercise: High-intensity interval training (HIIT) exercise
    Summary: HIIT alternates intense and recovery exercise periods; may inhibit cancer cell growth, lower PSA, and improve metabolic health in prostate cancer patients (Source: Summary of Web Search; NCI Thesaurus).

Key Inclusion

  • Males 18 to 80 years old
  • Localized prostate cancer diagnosis
  • Currently under active surveillance
  • Able to perform moderate-to-high intensity physical activity
  • Independent in activities of daily living
  • English proficiency
  • Able to consent and comply with study requirements

Key Exclusion

  • Currently receiving prostate cancer treatment
  • Metastatic prostate cancer diagnosis
  • Medical conditions contraindicating exercise
  • Uncontrolled cardiovascular disease, hypertension, or diabetes
  • Use of medications affecting steroid metabolism
  • Unable to consent or comply

NCT07801664

A Phase II Prospective Trial Utilizing Short Course Androgen Deprivation Therapy In Conjunction With Ultra-Hypofractionated SBRT For High Risk Nccn Prostate Cancer With Lower Risk Artera Scores Genomic-based

Organization/Sponsor: NYU Langone Health


Example patient: A 68-year-old man with biopsy-proven Gleason 9 prostate cancer, PSA 25 ng/mL, low ARTERA AI score, no nodal disease, testosterone 150 ng/dL, and no prior ADT or ARPi use.

Phase II

Interventions

  • Radiotherapy: Radiotherapy (Ultra-hypofractionated SBRT)
    Summary: High-energy beam radiation delivered in ultra-hypofractionated SBRT schedule to target and destroy prostate cancer cells, used curatively in combination with short-course ADT. Source: NCI Thesaurus.
  • Drug: Androgen Deprivation Therapy (ADT)
    Summary: Reduces serum testosterone via GnRH agonist/antagonist mechanisms to suppress prostate cancer growth; used short-term (<=3 months) alongside SBRT. Degarelix is a GnRH antagonist given as subcutaneous injections. Source: FDA label, NCI Thesaurus.

Key Inclusion

  • Biopsy-proven high-risk prostate cancer (Gleason 8-10 or PSA >20-40 ng/mL)
  • MRI stage T1-T3 without nodal involvement
  • Low or intermediate risk ARTERA AI score
  • No nodal metastases on MRI/CT/PSMA PET
  • Serum testosterone ≥120 ng/dL pre-ADT
  • KPS >80
  • Prostate size <90 cc
  • IPSS <22

Key Exclusion

  • Gleason 6-7 without PSA >20 ng/mL
  • PSA >40 ng/mL
  • Prior ADT >3 months duration
  • High-risk ARTERA score
  • Suspicious nodal metastases or metastatic disease
  • Metallic pelvic implant affecting MRI
  • Prior prostate cancer treatment (chemo/surgery, except TURP/PVP)
  • Current use of ARPis (enzalutamide, abiraterone, etc.)

NCT07218666

Phase II Study of Zanzalintinib in Men With Aggressive Variant Prostate Cancer (NAPOLEON Study) Genomic-based

Organization/Sponsor: Hoosier Cancer Research Network


Example patient: A 68-year-old man with metastatic castration-resistant prostate cancer, progressing after enzalutamide, with TP53 and RB1 alterations and visceral metastases, and good organ function, would qualify for this trial.

Phase 2

Interventions

  • Small molecule kinase inhibitor: Zanzalintinib
    Summary: Oral multi-kinase inhibitor targeting c-Met, VEGFR2, AXL, and MER receptor tyrosine kinases, blocking angiogenesis and tumor cell proliferation/invasion pathways; being studied for aggressive variant/castration-resistant prostate cancer. Source: NCI Thesaurus, Web Search Summary.

Key Inclusion

  • Age ≥18 with histologically confirmed prostate cancer
  • Metastatic disease (bone, lymph node, or visceral) per PCWG3/RECIST 1.1
  • Castration status with testosterone <50 ng/dL
  • Progressed on at least one prior androgen receptor pathway inhibitor
  • Features of aggressive variant disease (e.g., visceral mets, neuroendocrine markers, TP53/RB1/PTEN alterations)
  • Adequate organ and marrow function
  • ECOG performance status 0-2
  • Life expectancy ≥6 months

Key Exclusion

  • Pure small cell carcinoma of prostate
  • Prior treatment with zanzalintinib
  • Known/untreated brain metastases or spinal cord compression
  • Recent major surgery, radiation, or systemic anticancer therapy within specified windows
  • Uncontrolled cardiovascular disease or significant bleeding history
  • GI disorders with perforation/fistula risk
  • QTcF >480 ms
  • Active HIV/HBV/HCV infection unless controlled

NCT07278362

Safety of Intramuscular Testosterone Replacement Therapy in Hypogonadal Patients With Prostate Cancer Under Active Surveillance

Organization/Sponsor: University of Miami


Example patient: A 62-year-old man with newly diagnosed low-risk prostate cancer on active surveillance, PSA of 6 ng/mL, Gleason 6 disease, and confirmed low testosterone with fatigue symptoms, seeking TRT under study monitoring.

Phase N/A

Interventions

  • Drug: Testosterone cypionate
    Summary: Intramuscular androgen ester that restores testosterone levels in hypogonadal males; studied here for safety in men with low-risk prostate cancer on active surveillance (FDA label, NCI Thesaurus).

Key Inclusion

  • Males ≥18 years old
  • Newly diagnosed low-risk prostate cancer confirmed by fusion-guided biopsy and MRI
  • Confirmatory biopsy within last 12 months
  • On active surveillance
  • Two testosterone levels <300 ng/dL
  • Symptoms of low testosterone (AMS score >27)
  • Able to obtain testosterone medication
  • Able to provide informed consent

Key Exclusion

  • Prior TRT within past year or current use
  • Gleason score ≥7 (Grade Group 2+)
  • PSA >10 ng/mL
  • Hematocrit >51%
  • T3 or T4 disease
  • Uncontrolled cardiovascular disease or sleep apnea
  • History of breast cancer
  • Unable to comply with study requirements

NCT07594002

Comparing Acupuncture vs. Sham Acupuncture for the Management of Hot Flashes in Prostate Cancer Patients Receiving Hormone Therapy

Organization/Sponsor: University of Kentucky


Example patient: A 68-year-old man with metastatic prostate cancer on leuprolide for 8 months reports daily hot flashes, has ECOG status 1, no bleeding disorder, and can travel to appointments for acupuncture.

Phase N/A

Interventions

  • Procedure: Real Acupuncture
    Summary: Traditional Chinese medicine technique using needle insertion at specific points to stimulate nerves and meridians, aiming to reduce hot flashes; mechanism in prostate cancer not well-documented. Source: Summary of Web Search.
  • Procedure: Sham Acupuncture
    Summary: Control intervention mimicking acupuncture without true needle penetration, used to compare against real acupuncture for hot flash management; mechanism unclear but shows comparable effects in some studies. Source: Summary of Web Search.

Key Inclusion

  • History of prostate cancer on or within past 2 years of hormone therapy
  • ADT, androgen signaling inhibitors, or adrenal steroid synthesis inhibitors
  • May receive concurrent chemotherapy, radioligand, or targeted therapy
  • Hot flashes at least twice per day
  • May be using hot flash medications, no limit on number
  • ECOG performance status ≤3
  • Treated brain metastases without progression allowed
  • Prior or concurrent malignancy allowed

Key Exclusion

  • Unable to travel for acupuncture sessions
  • High bleeding tendency as determined by PI

NCT07682649

A Phase 1 Study to Investigate Safety of Escalating Cycle 1 Dose of Lu-177-PSMA-617 Radioligand Therapy (RLT) in Metastatic Castration Resistant Prostate Cancer (mCRPC): The ESCENDO Trial

Organization/Sponsor: University of Michigan Rogel Cancer Center


Example patient: A 68-year-old man with PSMA-positive mCRPC, ECOG 1, normal organ function, and no prior radioligand therapy who is eligible for standard Lu-177-PSMA-617 treatment.

Phase 1

Interventions

  • Radiopharmaceutical: Lutetium Lu 177 Vipivotide Tetraxetan
    Summary: PSMA-targeted radioligand delivering beta radiation to PSMA-expressing prostate cancer cells; approved for mCRPC treatment. Source: FDA label, NCI Thesaurus.
  • Radiopharmaceutical/Imaging Agent: Gallium Ga 68 Gozetotide
    Summary: PSMA-targeted PET imaging tracer used to identify PSMA-positive lesions and select patients for Lu-177-PSMA-617 therapy. Source: Summary of Web Search.
  • Imaging Procedure: Positron Emission Tomography
    Summary: Nuclear imaging technique visualizing metabolic/tracer activity, used here with Ga-68-PSMA to confirm PSMA-positive disease. Source: NCI Thesaurus.
  • Imaging Procedure: Computed Tomography
    Summary: X-ray based cross-sectional imaging used in combination with PET for staging and monitoring disease. Source: NCI Thesaurus.
  • Imaging Procedure: Single Photon Emission Computed Tomography
    Summary: Nuclear imaging using gamma rays to assess tracer distribution and organ function, potentially used for dosimetry monitoring in RLT. Source: Summary of Web Search.
  • Imaging Agent: Technetium Tc-99m Sulfur Colloid
    Summary: Radiopharmaceutical for imaging reticuloendothelial system (liver, spleen, marrow); may assess marrow involvement prior to RLT. Source: Summary of Web Search.
  • Procedure: Biospecimen Collection
    Summary: Collection of blood/tissue samples for correlative research on treatment response and safety biomarkers. Source: NCI Thesaurus.
  • Assessment Tool: Questionnaire Administration
    Summary: Patient-reported outcome measures to assess quality of life and treatment tolerability during the study. Source: NCI Thesaurus.

Key Inclusion

  • Eligible for standard Lu-177-PSMA617 RLT for mCRPC
  • PSMA PET/CT positive (lesion uptake > liver)
  • Recovered to ≤ Grade 2 toxicity from prior therapies
  • Age ≥18 years
  • ECOG performance status 0 or 1
  • Adequate hematologic function (ANC, platelets, hemoglobin)
  • eGFR ≥60 mL/min
  • Adequate liver function (bilirubin, ALT/AST, albumin)

Key Exclusion

  • Does not meet standard RLT eligibility criteria
  • Diffuse marrow involvement on Ga-68-PSMA PET/CT
  • Prior radioligand therapy
  • Unmanageable bladder outflow obstruction or incontinence
  • Serious cardiac, infectious, or hepatic comorbidities
  • Plans for additional anti-cancer therapy during study
  • Participation in other investigational trials within 30 days

NCT07564102

dMD-002 US Pilot Study A Single-center, Randomized, Double-blind, Pilot Study to Assess the Efficacy and Safety of dMD-002 in Patients After Radical Prostatectomy

Organization/Sponsor: Mochida Medical USA, Inc.


Example patient: A 62-year-old man newly diagnosed with localized prostate cancer scheduled for a bilateral nerve-sparing robot-assisted radical prostatectomy, with no prior prostate surgery, radiation, hormone therapy, or penile prosthesis.

Phase N/A

Interventions

  • Control: Control
    Summary: Comparator arm reflecting standard post-surgical management; not an active anti-cancer therapy in this trial. Source: Summary of Web Search.
  • Investigational Agent: dMD-002
    Summary: Investigational agent aimed at supporting neurovascular bundle recovery after radical prostatectomy, targeting nerve regeneration mechanisms rather than tumor biology. Source: Summary of Web Search.

Key Inclusion

  • Diagnosed with prostate cancer
  • Scheduled for robot-assisted radical prostatectomy
  • Bilateral or unilateral nerve-sparing surgery planned

Key Exclusion

  • Pre- or post-surgery radiation, hormone, or anti-cancer therapy
  • History of penile prosthesis implantation
  • Prior transurethral resection, laser, microwave, RFA, cryoablation, or other prostate surgery

NCT07224009

Phase II Clinical Trial Evaluating the Safety and Efficacy of Low Dose Naltrexone (LDN) for the Management of Fatigue in Prostate Cancer Patients on Androgen Deprivation Therapy (ADT)

Organization/Sponsor: University of Arkansas


Example patient: A 68-year-old man with biochemically recurrent prostate cancer, on ADT with enzalutamide for 4 months, ECOG 1, normal labs, and significant fatigue (FACIT-F score 38), with no recent chemotherapy or PARP inhibitor use.

Phase 2

Interventions

  • Drug: Naltrexone
    Summary: Low dose naltrexone, an opioid antagonist acting via opioid growth factor receptor modulation, is being studied to reduce fatigue in prostate cancer patients on ADT; mechanism in cancer unclear (Source: Summary of Web Search).

Key Inclusion

  • Biochemical recurrence or metastatic prostate cancer on ADT for at least 3 months
  • ADT initiated within 3 months of registration, with or without novel hormonal therapy
  • ECOG performance status <3
  • Normal organ and marrow function
  • LVEF >45%
  • FACIT-F score <43 on screening
  • Ability to provide informed consent

Key Exclusion

  • Chemotherapy within last 3 months
  • Currently on PARP inhibitors
  • Recent use of excluded medications within 10 days
  • Receiving other investigational agents
  • History of allergic reaction to naltrexone or similar agents
  • Other malignancies unless in remission >5 years
  • Uncontrolled intercurrent illness (infection, CHF, arrhythmia, psychiatric issues)
  • Acute hepatitis or liver failure