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

NCT07069465 | Completed Early Phase 1 FDA Drug

• 1 other identifier: STU-2023-1275
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

Prostate, Prostate Cancer, Androgen Deprivation Therapy, Posluma, Orgovyx, PSMA-PET

Outcome Measures

Primary Outcomes (4)

• 1. Mean change in maximum standardized uptake value (SUVmax) per lesion as measured by PSMA-PET (POSLUMA®) from baseline to post-ADT

  Time Frame: Baseline and 3-6 weeks after initiation of ADT Description: SUVmax will be measured on PSMA-PET for each lesion identified prior to ADT and again after 3 or 6 weeks of ADT (depending on cohort). The primary metric will be the mean change in SUVmax per lesion, per participant. Data will be summarized as mean ± SD, and analyzed using paired statistical testing to determine significance of change.

  3-6 weeks

• New lesions not identified pre-treatment are detectable after ADT

  Time Frame: Baseline and 3-6 weeks post-ADT initiation Description: PSMA-PET scans performed at 3 or 6 weeks after ADT will be compared to baseline scans to identify newly visible lesions. The outcome will be reported as the number and proportion of participants with new lesions. Descriptive statistics will be used to summarize findings.

  3-6 weeks

• Establish the optimal duration of ADT necessary to achieve castrate level of testosteroneTime to castration-level testosterone (≤50 ng/dL) following initiation of oral ADT (relugolix 120 mg daily)

  Time Frame: 0 to 6 weeks after initiation of ADT Description: Serum testosterone will be measured at baseline, 3 weeks, and 6 weeks. The time point at which testosterone ≤50 ng/dL is first achieved will be recorded for each participant. Data will be summarized by frequency, proportion, and median time to castration levels.

  3-6 weeks

• Proportion of lesions visible on baseline PSMA-PET that remain detectable on post-ADT PSMA-PET

  Time Frame: Baseline and 3-6 weeks after initiation of ADT Description: Lesions identified at baseline will be matched to post-ADT PSMA-PET scans. The number and proportion of lesions that remain visible after ADT will be recorded. This will help assess whether ADT obscures PSMA-positive disease on imaging.

  3-6 weeks

Secondary Outcomes (2)

• Correlation between PSMA-PET findings and surgical pathology

  3-6 weeks

• Concordance between study PSMA-PET and conventional imaging or alternative PSMA-PET agents (if available)

  3-6 weeks

Study Arms (2)

Cohort A

ACTIVE COMPARATOR

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.

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

Cohort B

ACTIVE COMPARATOR

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.

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

Interventions

flotufolastat F 18 DIAGNOSTIC_TEST

PSMA-PET scan with Posluma agent (x2)

Also known as: Posluma

Cohort A; Cohort B

Relugolix 120 MG DRUG

Administration of oral ADT for 3 and 6 weeks

Also known as: Orgovyx

Cohort A; Cohort B

Serum PSA and Testosterone DIAGNOSTIC_TEST

Serum PSA and testosterone at study initiation and again at 3 and 6 weeks after initiation of ADT

Cohort A; Cohort B

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Urology Clinics of North Texas: lead
• Blue Earth Diagnostics: collaborator
• Texas Health Resources: collaborator

Study Sites (1)

Urology Clinics of North Texas

Dallas, Texas, 75231, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

relugolix

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2024
• First Posted: July 16, 2025
• Study Start: June 15, 2024
• Primary Completion: November 6, 2024
• Study Completion: November 6, 2024
• Last Updated: July 16, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)