Clinical trial · Interventional
Pilot Study: Androgen Deprivation Therapy Impact on PSMA-PET Sensitivity in Prostatectomy Staging
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| flotufolastat F 18 | Diagnostic Test | — | UNRESOLVED |
| Relugolix 120 MG | Drug | Relugolix | ALIAS |
| Serum PSA and Testosterone | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Cohort A
- 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.
- interventionNames
- Diagnostic Test: flotufolastat F 18
- Drug: Relugolix 120 MG
- Diagnostic Test: Serum PSA and Testosterone
- type
- ACTIVE_COMPARATOR
- label
- Cohort B
- 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.
- interventionNames
- Diagnostic Test: flotufolastat F 18
- Drug: Relugolix 120 MG
- Diagnostic Test: Serum PSA and Testosterone
Primary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
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: \-
References
Publications (0)
Data not yet available