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


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


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


mCRPC

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


Post 1L ARTT in mCSPC or CRPC setting

Exelixis Stellar-002 expansion: A Dose-Escalation and Expansion Study of the Safety and Efficacy of XL092 in Combination with Immuno-Oncology Agents in Subjects with Unresectable Advanced or Metastatic Solid Tumors

Phase: 1b
Study Product: cohort 3: post 1L ARTA for CSPC or CRPC- Arm1: XL092 alone vs Arm 2: XL092 + Nivo
Estimated Study Completion Date: October 24, 2025
ClinicalTrials.gov Identifier: NCT03460977


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.