Pilot Study: Androgen Deprivation Therapy Impact on PSMA-PET Sensitivity in Prostatectomy Staging (PIONEER PSMA)

Urology Clinics of North Texas

Status and phase: Completed; Early Phase 1

Conditions: Prostate Cancer

Treatments: Diagnostic Test: flotufolastat F 18; Drug: Relugolix 120 MG; Diagnostic Test: Serum PSA and Testosterone

Study type: Interventional

Funder types: Other; NETWORK; Industry

Identifiers

NCT07069465

STU-2023-1275

Details and patient eligibility

About

This is a pilot, non-randomized, two-cohort interventional study in patients who meet the inclusion criteria, using an FDA- approved androgen deprivation agent for a 3 or 6-week course of treatment prior to standard-of-care RALP with PLND. The intent of the study is to determine the effect of ADT on PSMA expression as measured by PSMA-PET scan. A second PSMA-PET scan will be performed after ADT for either 3 or 6 weeks, depending on cohort, prior to RALP and PLND.

Enrollment: 10 patients

Sex: Male

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men diagnosed with unfavorable intermediate or high-risk prostate cancer where RALP and PLND is planned and consulted with primary urologist

Exclusion criteria

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

10 participants in 2 patient groups

Cohort A

Active Comparator group

Description:

5 patients (Cohort A) undergo a second study PSMA-PET with POSLUMA® 3 weeks after initiation of ADT and discontinue ADT immediately after the scan is completed.

Treatment:

Diagnostic Test: Serum PSA and Testosterone

Drug: Relugolix 120 MG

Diagnostic Test: flotufolastat F 18

Cohort B

Active Comparator group

Description:

5 patients (Cohort B) undergo a second study PSMA-PET with POSLUMA® 6 weeks after initiation of ADT and discontinue ADT immediately after the scan is completed.

Treatment:

Diagnostic Test: Serum PSA and Testosterone

Drug: Relugolix 120 MG

Diagnostic Test: flotufolastat F 18