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Completed

NCT Number: NCT07069465

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Sex eligibility

Male

Study type

Interventional

Phase

Early Phase 1

Primary location

Urology Clinics of North Texas

Dallas, Texas, 75231, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

flotufolastat F 18

Diagnostic Test

PSMA-PET scan with Posluma agent (x2)

Other names: Posluma

Relugolix 120 MG

Drug

Administration of oral ADT for 3 and 6 weeks

Other names: Orgovyx

Serum PSA and Testosterone

Diagnostic Test

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

Primary outcomes

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

    Time frame: 3-6 weeks

    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.

  2. New lesions not identified pre-treatment are detectable after ADT

    Time frame: 3-6 weeks

    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. 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: 3-6 weeks

    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.

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

    Time frame: 3-6 weeks

    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.

Secondary outcomes

  1. Correlation between PSMA-PET findings and surgical pathology

    Time frame: 3-6 weeks

    Time Frame: Surgery performed 6-10 weeks after enrollment Description: Lesions identified by PSMA-PET will be compared to histopathologic findings from prostatectomy and pelvic lymph node dissection specimens. Correlation statistics (e.g., sensitivity, specificity, positive predictive value) will be calculated.

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

    Time frame: 3-6 weeks

    Time Frame: 3-6 weeks after ADT, when comparator imaging is available Description: In participants who undergo additional imaging (e.g., bone scan, CT, or alternative PSMA-PET tracers), lesions will be compared to those seen on study PSMA-PET. Concordance will be reported as number and proportion of lesions detected by both modalities.

Sponsors and collaborators

Lead sponsor

Urology Clinics of North Texas

Network

Collaborators

  • Blue Earth Diagnostics
  • Texas Health Resources

Registry information

Official study title

Pilot Study to Determine the Effect of Androgen Deprivation Therapy on the Sensitivity of PSMA-PET Scanning for Patients Undergoing Initial Staging Prior to Robot-Assisted Laparoscopic Radical Prostatectomy and Pelvic Lymphadenectomy

Acronym: PIONEER PSMA

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 16, 2025
Registry last updated
Jul 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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