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


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 CLARIFYPositron 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


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


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 allowedPart 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 Enzapart 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


ARV-766 with AR-LBD: 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 ARTA for mCSPC or mCRPC (2 lines chemo allowed)- Part B phase 2 dose expansion: oral ARV-766 (AR PROTAC)- must have AR-LBD mutation 
Estimated Study Completion Date: June 27, 2025
ClinicalTrials.gov Identifier: NCT05067140


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.