Assessing Efficacy of Neoadjuvant ADT in Localized High-Risk Prostate Cancer Patients Utilizing 18F-Flotufolastat PSMA PET/CT

What Was Tested

The trial (phase 2) is built around Leuprolide and Triptorelin.

Follow up will be 48 months your prostate removal to do a blood test and log if any new or worsening symptoms have occurred as a part of your standard-of-care (SOC).

It had 1 arm (groups): Neoadjuvant androgen deprivation therapy (ADT) followed by radical prostatectomy (RP) (experimental).

The registry classes the interventions as diagnostic test, drug and procedure.

More on the Plan

This is a single-arm, phase II, open label study in patients with localized high- risk prostate cancer (LHRPC) treated with neoadjuvant ADT (leuprolide, degarelix, relugolix, or triptorelin) followed by radical prostatectomy (RP).

Additionally, it will investigate the prognostic value of SUVmax changes in predicting biochemical recurrence-free survival.

Who Took Part

The registry lists 50 planned participants were the target.

It was open to men only aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Signed informed consent must be obtained prior to participation in the study. Males aged ≥18 years. ECOG performance status ≤ 1. Histologically confirmed adenocarcinoma of the prostate in a patient amenable to radical prostatectomy. Pathologically proven prostate adenocarcinoma with ≥ 1 High-risk feature based on NCCN guidelines.

The full record lists 14 inclusion and 13 exclusion criteria; among the exclusions: known allergies, hypersensitivity, or intolerance to 18f-flotufolastat; unable to receive androgen deprivation therapy; history of prior radiation therapy for prostate cancer.

How the Study Was Run

The set-up was single-group and open-label.

Everyone knew when Leuprolide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2026-07-29 with completion listed for 2030-02.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Objective response rate (ORR) based on PSMA PET (time frame: 6 Months). ORR based on Response Evaluation Criteria in PSMA Imaging (RECIP 1.0) (time frame: 6 Months).

It also tracked 2 secondary outcomes, for example Prostate-Specific Antigen (PSA) response rate and Biochemical recurrence-free survival (BCR) with testosterone recovery.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Leuprolide and Triptorelin in 50 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Leuprolide compound page and the Triptorelin compound page, all human trials.