Studies

Our study portfolio

Our trials span the entire disease continuum, strategically aligned with the most promising targets and biomarkers in development today.

Active study portfolio

Active interventional studies

Managed by the PCCTC

Studies open to accrual are listed first.

  • STRIKE-001: Phase 1, Dose-Escalation Study of KTX2001 (an NSD2 Inhibitor) Alone and in Combination With Darolutamide for Metastatic Castration-Resistant Prostate Cancer

    Phase 1Open to accrual
    NCT07103018
  • PSMA-007-001: A Phase 1, Open-Label, Multicenter Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer

    Phase 1Open to accrual
    NCT05519449
  • TALENT: TALazoparib with or without ENzaluTamide in patients with metastatic castration-resistant prostate cancer and HRR mutations after progression on abiraterone acetate

    Phase 2Open to accrual
    NCT06844383
  • TIDAL: Phase 2 Study of Tarlatamab in Patients With Delta-like Protein 3 (DLL3) Positive Metastatic Prostate Cancer

    Phase 2Open to accrual
    NCT07111507
  • TIP: A Phase 1b/2 Study Evaluating the Activity of Tinengotinib (TT-00420) in Combination With Androgen Receptor Signaling Inhibitors (ARSIs) in Patients With Metastatic Castration Resistant Prostate Cancer

    Phase 1b/2Open to accrual
    NCT06457919
  • MOMENT: A Phase 2, Open-label, Single-Arm Study of Mevrometostat Plus Enzalutamide in Metastatic Castration-Resistant Prostate Cancer Following Prior Androgen Receptor Pathway Inhibitor Therapy

    Phase 2In development
    NCT07592910
  • LuX: A Feasibility Study of Xaluritamig in Participants With Metastatic Castrate Resistant Prostate Cancer and Suboptimal Response to Lutetium 177 Vipivotide Tetraxetan

    Phase 2In development
    NCT07737925
  • PRESERVE-006: Randomized Study of ONC-392 Plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC) Who Progressed on Androgen Receptor (AR) Pathway Inhibition

    Phase 1/2Closed to accrual
    NCT05682443
  • DASL-HiCaP: Darolutamide Augments Standard Therapy for Localised Very High-Risk Cancer of the Prostate (ANZUP1801). A randomised phase 3 double-blind, placebo-controlled trial of adding darolutamide to androgen deprivation therapy and definitive or salvage radiation in very high risk, clinically localised prostate cancer

    Phase 3Closed to accrual
    NCT04136353
  • DORA: A Phase III Trial of Docetaxel vs. Docetaxel and Radium-223 for Metastatic Castration-Resistant Prostate Cancer

    Phase 3Closed to accrual
    NCT03574571
  • NivoDoce: A Phase 2 Multicohort Study of Nivolumab in Combination With Docetaxel and Androgen Deprivation Therapy in Metastatic Hormone Sensitive Prostate Cancer Patients With DNA Damage Repair Defects or Inflamed Tumors

    Phase 2Pending closure
    NCT04126070
  • SAABR: Single Arm Phase II Study of AR Targeted Therapy + Atezolizumab + GnRH Analog and Stereotactic Body Radiotherapy (SBRT) to the Prostate in Men With Newly Diagnosed Hormone-sensitive Metastatic Prostate Cancer

    Phase 2Pending closure
    NCT04262154
  • MetaCure: Multi-arm Multi-modality Therapy for Very High Risk Localized and Low Volume Metastatic Prostatic Adenocarcinoma

    Phase 2Pending closure
    NCT03436654
  • Ribo-X: Phase IB/II Study of Enzalutamide With Ribociclib in Patients With Metastatic Castrate Resistant, Chemotherapy Naïve Prostate Cancer That Retains RB Expression

    Phase 1b/2Pending closure
    NCT02555189

Open at consortium sites

Most recently registered first.

  • IRRADIANT: IRreversible Electroporation versus RADIAtioN BoosT for Intermediate Risk Prostate Cancer

    Phase 3
    NCT07548164
  • A Phase 1/2 First-Time-in-Human, Open-label, Multicenter, Dose Escalation and Dose Optimization Study of GSK5471713 in Adult Participants With mCRPC

    Phase 1/2
    NCT07332455
  • 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 mCRPC

    Phase 2
    NCT07287150
  • AB-3028, a Programmable Circuit T Cell Therapy in Patients with CRPC

    Phase 1/2
    NCT07285694
  • A Phase 1, Multicenter Trial Evaluating the Safety, Tolerability, and Efficacy of Valemetostat (DS-3201) in Combination with Darolutamide in mCRPC

    Phase 1
    NCT07244341
  • TulmiSTAR-01: A Two-part, Phase I Dose Escalation and Expansion Followed by a Randomized, Open-label Multicenter, Phase II Study to Assess the Safety and Efficacy of the Combination of Tulmimetostat (DZR123) and JSB462 (Luxdegalutamide) vs Standard of Care in Patients with Progressive mCRPC

    Phase 1/2
    NCT07206056
  • SEACLIFF: A Modular Phase I/IIa, Open-label, Multi-centre Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of AZD0516 as Monotherapy and in Combination with Anti-cancer Agents in Participants with Metastatic Prostate Cancer

    Phase 1/2a
    NCT07181161
  • A Phase 1b Study of 177Lu-PSMA-617 Combined with Liver Directed Therapy in mCRPC

    Phase 1b
    NCT07145177
  • A Phase 1b Open-label, Multicenter Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Combination with Androgen Receptor Pathway Inhibitors in Participants with mHSPC

    Phase 1b
    NCT07140900
  • A Phase 1b Study of JNJ-78278343, a T-cell Redirecting Agent Targeting Human Kallikrein 2 (KLK2), in Combination With JNJ-95298177, an Antibody Drug Conjugate Targeting Prostate Specific Membrane Antigen, for Prostate Cancer

    Phase 1b
    NCT07082920
  • A Study of FG-3246 in Participants With mCRPC

    Phase 2
    NCT06842498
  • Phase 1 Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of ACE-232 in Patients with mCRPC

    Phase 1
    NCT06801236
  • Phase 1/2 Study of HLD-0915 in Patients with mCRPC

    Phase 1/2
    NCT06800313
  • A Phase 1b/2a, Multicenter, Open-Label Study of Pocenbrodib as Monotherapy and in Combination with Abiraterone Acetate, Olaparib, or 177Lu-PSMA-617 in Participants With mCRPC

    Phase 1b/2a
    NCT06785636
  • A Phase 1a/b Study of ADRX-0405 in Subjects with mCRPC and Select Advanced Solid Tumors

    Phase 1a/b
    NCT06710379
  • PHAROS: Phase 1 First in Human Trial to Assess Safety and Tolerability of the Novel ACK1 Inhibitor (R)-9bMS in Patients with Prostate Cancer

    Phase 1
    NCT06705686
  • Phase II Trial Targeting Gut Bacterial Androgen Production to Reverse Therapeutic Resistance to Abiraterone in Patients with Metastatic Prostate Cancer

    Phase 2
    NCT06616597
  • CONVERGE-01: A Phase 2, Open-label Study Evaluating Dosimetry, Randomized Dose Optimization, Dose Escalation and Efficacy of Ac-225 Rosopatamab Tetraxetan in Participants with PSMA PET-Positive CRPC

    Phase 2
    NCT06549465
  • Phase 1 Study of MOMA-313 Given as Monotherapy or in Combination with a PARP Inhibitor in Participants with Advanced or Metastatic Solid Tumors

    Phase 1
    NCT06545942
  • LEGION-100: A Phase 1b Open-Label, Dose-Escalation Study of SYNC-T Therapy SV-102 in Patients Diagnosed with mCRPC

    Phase 1b
    NCT06533644
  • RADIODOSE: A Study of Radiation Dosimetry, Safety, and Tolerability of Extended Lutetium (177Lu) Vipivotide Tetraxetan Treatment in Chemo-naïve Adults with mCRPC: RADIOpharmaceutical DOSimetry Evaluation (RADIODOSE)

    Phase 1
    NCT06531499
  • A Phase 2 Study of Biomarker-Modulated PSMA Theranostics: Low PSMA SUV Boost (LPS-Boost) – Intensified 177Lu-PSMA-617 Treatment for Patients with mCRPC with Low PSMA Expressing Disease

    Phase 2
    NCT06526299
  • DIVINE: Stereotactic Body Radiation Therapy Plus Androgen Receptor Pathway Inhibitor and Androgen Deprivation Therapy for Treatment of Metastatic, Recurrent HSPC

    Phase 2
    NCT06378866
  • MK-5684-01A Substudy: A Phase 1/2 Umbrella Substudy of MK-5684-U01 Master Protocol to Evaluate the Safety and Efficacy of MK-5684-based Treatment Combinations or MK-5684 Alone in Participants With mCRPC

    Phase 1/2
    NCT06353386
  • A Phase 2, Single-Arm Study of the CXCR1/2 Inhibitor SX-682 Plus Enzalutamide in Men with Abiraterone-Resistant mCRPC

    Phase 2
    NCT06228053
  • A Phase 1/2, Open-Label, Randomized, Dose Finding and Dose Expansion Study of Gedatolisib in Combination with Darolutamide in mCRPC

    Phase 1/2
    NCT06190899
  • Developing and Testing a Patient-Centered Tumor Genomic Pre-Test Counseling Tool for African-American men with Metastatic Prostate Cancer

    NCT06171139
  • METANOVA: Metastasis-directed radiotherapy (MDRT) for men with de-novo oligometastatic prostate cancer treated with long-term androgen deprivation therapy in the STAMPEDE trial

    Phase 2
    NCT06150417
  • A Phase 1 Study of JNJ-87189401 (PSMA-CD28 Bispecific Antibody) Combined with JNJ-78278343 (KLK2-CD3 Bispecific Antibody) for Advanced Prostate Cancer

    Phase 1
    NCT06095089
  • A Phase 1, Open-label Study of BMS-986460 in Participants with mCRPC

    Phase 1
    NCT06067841
  • Internet-Based Lifestyle Intervention (iLIVE) to Eradicate Obese Frailty in Prostate Cancer Survivors

    NCT06011499
  • A Phase 1/2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1311 in Subjects with Advanced/Metastatic Solid Tumors

    Phase 1/2a
    NCT05914116
  • A Randomized Phase II Trial of Neoadjuvant Enzalutamide Plus the Glucocorticoid Receptor Antagonist Relacorilant Versus Placebo for Patients with High-Risk Localized Prostate Cancer

    Phase 2
    NCT05726292
  • A Phase II Study of Lutetium Lu 177 Dotatate in Metastatic Prostate Cancer with Neuroendocrine Differentiation

    Phase 2
    NCT05691465
  • The SKYBRIDGE study, an Open-label, Multicenter, Dose Escalation and Dose Expansion Phase 1/2 Study with PT217 Followed by a Key ChemotherapY and/or Checkpoint Inhibitor ComBination in Patients with NeuRoendocrIne Carcinomas That Are Known to Be DLL3 ExpressinG CancErs

    Phase 1/2
    NCT05652686
  • SNARE: A Single-Arm Phase II Study of Neoadjuvant Intensified Androgen Deprivation (Leuprolide and Abiraterone Acetate) in Combination with AKT Inhibition (Capivasertib) for High-Risk Localized Prostate Cancer with PTEN Loss

    Phase 2
    NCT05593497
  • A Phase 1 Study of EP31670, a Dual BET and CBP/p300 Inhibitor in Patients with Targeted Advanced Solid Tumors and Hematological Malignancies

    Phase 1
    NCT05488548
  • A Phase 2 Randomized Study of Abiraterone Acetate, Enzalutamide or Apalutamide as First Line Therapy in Veterans with CSPC

    Phase 2
    NCT05422911
  • An Open-Label, Phase 1/1b, Study of ORIC-944 in Patients with Metastatic Prostate Cancer

    Phase 1/1b
    NCT05413421
  • TERPS: Phase 2 Randomized Total Eradication of Metastatic Lesions Following Definitive Radiation to the Prostate in de Novo oligometaStatic Prostate Cancer (TERPS) Trial

    Phase 2
    NCT05223803
  • VA Bipolar Androgen Therapy (VA-BAT Trial): High-dose Testosterone in Men with mCRPC and ATM, CDK12, or CHEK2 deficiency

    Phase 2
    NCT05011383
  • Randomized Phase 2b Study of ZEN003694 in Combination with Enzalutamide versus Enzalutamide Monotherapy in Patients with mCRPC

    Phase 2b
    NCT04986423
  • Phase I/II Trial of Pembrolizumab and Androgen-Receptor Pathway Inhibitor with or without 225Ac-J591 for Progressive mCRPC

    Phase 1/2
    NCT04946370
  • A Phase I/IIa Theranostic Study of 64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA for Identification and Treatment of PSMA-expressing mCRPC [SECuRE (Systematic Cu Theranostics in Prostate Cancer)]

    Phase 1/2a
    NCT04868604
  • GUNS: Genomic Biomarker-Selected Umbrella Neoadjuvant Study for High Risk Localized Prostate Cancer

    Phase 2
    NCT04812366
  • The STEP-UP Trial: Randomized Phase II Study Comparing Sequential High Dose Testosterone and Enzalutamide to Enzalutamide alone in Asymptomatic Men with mCRPC

    Phase 2
    NCT04363164
  • A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 509 in Subjects With mCRPC

    Phase 1
    NCT04221542
  • COBRA: Carboplatin or Olaparib for BRcA Deficient Prostate Cancer

    Phase 2
    NCT04038502
  • A Phase 1/2 Study of REGN5678 (Anti-PSMAxCD28) with Cemiplimab (Anti-PD-1) in Patients with mCRPC and Other Tumors Associated with PSMA Expression

    Phase 1/2
    NCT03972657
  • A Phase I Dose Escalation and Expanded Cohort Study of PF-06821497 in the Treatment of Adult Patients with Relapsed/Refractory Small Cell Lung Cancer (SCLC), Castration Resistant Prostate Cancer (CRPC) and Follicular Lymphoma (FL)

    Phase 1
    NCT03460977