Favorable Intermediate Risk Prostate Cancer
Focal Therapy
Francis Medical Vapor-2: Prospective, Multicenter, Single-Arm Study of VanquishTM Water Vapor Ablation for PrOstate CanceR
Phase: N/A
Study Product: Vanquish Water Vapor Ablation locatlized FIR PCa (GG 2 & PSA < 15)
Estimated Study Completion Date: April 2029
ClinicalTrials.gov Identifier: NCT05683691
Radical Prostatectomy Candidates
Clarity CLARIFY: Positron Emission Tomography Using 64Cu-SAR-bisPSMA in Participants With High-risk Prostate Cancer Prior to Radical Prostatectomy
Phase: 3
Study Product: 64Cu-SAR-bisPSMA
Estimated Study Completion Date: February 2025
ClinicalTrials.gov Identifier: NCT06056830
Curium SOLAR-stage: Phase 3, Multi-Center, Open-label Study to Test the Diagnostic Performance of Copper Cu 64 PSMA I&T PET/CT in Staging Men With Newly Diagnosed Unfavorable Intermediate-risk, High-risk or Very High-risk Prostate Cancer Electing to Undergo Radical Prostatectomy With Pelvic Lymph Node Dissection
Phase: 3
Study Product: Cu64 PSMA I&T PET/CT for unfavorable intermediate-risk, high or very high risk PCa prior to RP- diagnostic study only
Estimated Study Completion Date: July 2025
ClinicalTrials.gov Identifier: NCT06235151
PSA Relapse
Vaccitech: A Phase 1/Phase 2 Trial to Evaluate Safety, Immunogenicity and PSA Response of VTP-850 Prostate Cancer Immunotherapeutic in Men With Biochemical Recurrence After Definitive Local Therapy for Prostate Cancer
Phase: 1/2
Study Product: VTP-850 (viral vector) prime-boost regimens with booster IM for BCR
Estimated Study Completion Date: April 2027
ClinicalTrials.gov Identifier: NCT05617040
ARASTEP: A randomized, double-blind, placebo-controlled Phase 3 study of darolutamide plus androgen deprivation therapy (ADT) compared with placebo plus ADT in patients with high-risk biochemical recurrence (BCR) of prostate cancer
Phase: 3
Study Product: Darolutamide (placebo-controlled) + ADT +/- IGRT for BCR with positive PSMA PET
Estimated Study Completion Date: February 28, 2029
ClinicalTrials.gov Identifier: NCT05794906
Curium SOLAR-recur: A Phase 3, Multi-Center, Open-label Study to Test the Diagnostic Performance of Copper Cu 64 PSMA I&T PET/CT in Men With Biochemical Recurrence of Prostate Cancer
Phase: 3
Study Product: Cu64 PSMA I&T PET/CT for BCR- diagnostic study only
Estimated Study Completion Date: July 2025
ClinicalTrials.gov Identifier: NCT06235099
ADT Candidate
Debiopharm: A Phase 2, Randomized, Open-Label, Dose-Finding Study of Debio 4228, an Extended-Release Formulation of Gonadotropin-Releasing Hormone Antagonist in Participants With Locally Advanced/Metastatic Prostate Cancer
Phase: 2
Study Product: dose-finding study of Debio 4228 (GnRH) 3M formulation- one 3M dose then switch to SOC
Estimated Study Completion Date: April 2026
ClinicalTrials.gov Identifier: NCT06395753
MCSPC
Treatment Naïve
Petranha: A Multi-arm, Open-label Phase I/IIa Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of AZD5305 in Combination with New Hormonal Agents in Patients with Metastatic Prostate Cancer (PETRANHA)
Phase: 1/2a
Study Product: Part B cohort 3 Arm 3: AZD5305 (PARPi) + Daro. Pts can start ADT within 4M of consent
Estimated Study Completion Date: June 7, 2030
ClinicalTrials.gov Identifier: NCT05367440
EvoPAR: A Randomized, 2-cohort, Double-blind, Placebo-controlled, Phase III Study of Saruparib (AZD5305) in Combination With Physician’s Choice New Hormonal Agents in Patients With HRRm and Non-HRRm Metastatic Castration-Sensitive Prostate Cancer (EvoPAR-Prostate01)
Phase: 3
Study Product: AZD5305 (PARPi) (placebo-controlled) + ARTA of MD choice
Estimated Study Completion Date: April 30, 2031
ClinicalTrials.gov Identifier: NCT06120491
mCSPC or mCRPC
No prior ARTA
ARV-766: A Phase 1/2 Open-Label, Dose-Escalation and Cohort Expansion Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ARV-766 in Patients with Metastatic Castration-Resistant Prostate Cancer
Phase: 1/2
Study Product: no prior ARTA, prior chemo allowed– Part C: Abi + ADT 8 day lead-in then add ARV-766 (AR PROTAC)
Estimated Study Completion Date: June 27, 2025
ClinicalTrials.gov Identifier: NCT05067140
CRPC
c2321001: A Phase 1 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
Study Product: CRPC ± mets, post Abi and/or Enza– part 1C EZH2i alone; part 2A EZH2i + Enza
Estimated Study Completion Date: October 24, 2025
ClinicalTrials.gov Identifier: NCT03460977
mCRPC
Treatment Naïve
ESSA: A Phase 1/2 Study of EPI-7386 in Combination With Enzalutamide Compared With Enzalutamide Alone in Subjects With Metastatic Castration-Resistant Prostate Cancer
Phase: 1/2
Study Product: no prior ARTA- Masofaniten (aniten) + Enza vs Enza alone
Estimated Study Completion Date: January 2026
ClinicalTrials.gov Identifier: NCT05075577
Post Abi, Enza, Apa, and/or Daro in mCSPC or mCRPC setting (prior chemo allowed)
Propella: Open-Label, Multicenter Study of Intramuscular PRL-02 Depot in Patients with Advanced Prostate Cancer
Phase: 1
Study Product: post Abi and/or Enza (4wk washout)- must have ADT ≥1 month and T 2-49 ng/dL- IM Abi depot + Pred
Estimated Study Completion Date: April 30, 2025
ClinicalTrials.gov Identifier: NCT04729114
Post Doce
MK365: Phase Ib/II Trial of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (mCRPC) (KEYNOTE-365)
Phase: 1b/2
Study Product: Cohort E: Pembro + Lenvatinib; Cohort F: t-NE-Pembro + Lenvatinib; Cohort G: Pembro + Vibostolimab; Cohort H: t-NE-Pembro + Vibostolimab
Estimated Study Completion Date: May 30, 2025
ClinicalTrials.gov Identifier: NCT02861573
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date. Please remember to talk to your healthcare providers first before making decisions about your plan of care.
Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study. To learn more about our trials, call Jennifer at (843) 449-1010 ext. 316 or email us by filling out the form below.
