Prostate Cancer

Prostate Biopsy

ExactVu OPTIMUM: Optimization of Prostate Biopsy – Micro-Ultrasound versus MRI (OPTIMUM): A 3-arm randomized controlled trial evaluating the role of 29MHz micro-ultrasound in guiding prostate biopsy in men with clinical suspicion of prostate cancer (EVU-2021-001)

Phase: N/A
Study Product: Optimization of prostate biopsy- ExactVu (no MRI) vs Uronav vs ExactVu fusion with MRI- pts must enroll in study before getting MRI
Estimated Study Completion Date: December 2024
ClinicalTrials.gov Identifier: NCT05220501

Newly Diagnosed 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

PROTEUS substudy: A Study of ERLEADA (Apalutamide) in Participants With High‑Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy

Phase: 3
Study Product: ADT + Apa- 6M before and after RP vs RP + SOC (1:3) (Gleason ≥8 or PSA ≥20)
Estimated Study Completion Date: April 7, 2027
ClinicalTrials.gov Identifier: NCT03767244

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

MCSPC

mCRPC

Post Abi and/or Enza in mCSPC or mCRPC setting

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 Abi, Enza, Apa, and/or Daro (prior chemo allowed)

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: post 1-3 ARTT for mCSPC/mCRPC (2 lines chemo allowed)- dose expansion oral ARV-766 (AR PROTAC)
Estimated Study Completion Date: June 27, 2025
ClinicalTrials.gov Identifier: NCT05067140

MacroGenics: A Phase 2/3, Randomized, Open-label, Study of MGC018 Versus Androgen Receptor Axis-targeted Therapy (Abiraterone or Enzalutamide) in Participants with Metastatic Castration-resistant Prostate Cancer

Phase: 2/3
Study Product: post Doce and post 1L ARTT- MGC018 2 mg/kg IV Q4W vs MGC018 2.7 mg/kg IV Q4W vs ARRT (1:1:1) 
Estimated Study Completion Date: December 2026
ClinicalTrials.gov Identifier: NCT05551117

Post Doce