NCT05919329

Evaluation of the Change in PSMA Expression in Prostate Cancer in Response to Hormonal Therapy

Modulation of PSMA Expression in Castration Sensitive and Castration Resistant Prostate Cancer in Response to Hormonal Therapy

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: OHSU Knight Cancer Institute · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial investigates the change in prostate-specific membrane antigen (PSMA) expression in response to hormonal therapy in both, Castration Sensitive Prostate Cancer (CSPC) and Castration Resistant Prostate Cancer (CRPC), and whether this change in PSMA expression changes tumor staging after therapy initiation. Understanding these effects can help define the best timing to perform the PSMA positron emission tomography (PET) relative to the start of therapy.

Detailed description

PRIMARY OBJECTIVE: I. To determine the early effects (at day 8) of hormonal therapy on PSMA modulation in patients with castration sensitive prostate cancer (CSPC) and castration resistant prostate cancer (CRPC) SECONDARY OBJECTIVES: I. To evaluate the effects of hormonal therapy on PSMA modulation at day 28 post-therapy in patients with CSPC and CRPC II. To evaluate whether the change in PSMA modulation after hormonal therapy initiation changes the tumor staging on PSMA PET as defined by the PROMISE V2 criteria. EXPLORATORY OBJECTIVES: I. To assess whether the initial change in PSMA modulation in response to hormonal therapy holds prognostic implications II. To assess for potential correlation between the early change in PSMA modulation and tumor characteristics such as Gleason score, and site of disease. III. To assess whether the baseline level of PSMA uptake holds prognostic implications in response to hormonal therapy OUTLINE: Patients will be divided (non-randomized) into 2 groups (CRPC or CSPC) and receive PSMA PET prior to start of therapy (standard of care), then again 8 days and 28 days after initiation of hormonal therapy. Participants will be followed for up to 5 years.

Conditions

• Castration Resistant Prostate Cancer
• Castration Sensitive Prostate Cancer
• Prostate Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Piflufolastat	Given IV
PROCEDURE	PSMA PET/CT Scan	Undergo PSMA PET/CT
PROCEDURE	PSMA PET/MRI scan	Undergo PET/MRI
PROCEDURE	Biospecimen Collection	Undergo collection of blood samples
OTHER	Electronic Health Record Review	Ancillary studies

Timeline

• Start date: 2024-06-25
• Primary completion: 2028-09-01
• Completion: 2030-09-01
• First posted: 2023-06-26
• Last updated: 2025-10-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study