A Neoadjuvant Study of Abiraterone Acetate, Leuprolide Acetate, and Belzutifan in Men With Regional Prostate Cancer

What Was Tested

In this phase 2 trial, researchers set out to test Leuprolide.

Many men undergo radical prostatectomy (total removal of the prostate) along with the removal of nearby lymph nodes.

Other men may opt for androgen deprivation therapy (ADT, a therapy that blocks testosterone) using the two drugs leuprolide and abiraterone - with or without radiation.

It had 1 arm (groups): Open-Label Treatment Group (experimental).

Participants will be treated with neoadjuvant therapy for a total of 3 months (12 weeks) prior to prostatectomy. Therapy will consist of leuprolide acetate, abiraterone acetate, and belzutifan.

The registry classes the interventions as drug.

More on the Plan

Participants will have PSA checked 1 year and 2 years after surgery.

Who Took Part

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: Willing and able to provide written informed consent. Age ≥ 18 years. Eastern cooperative group (ECOG) performance status ≤2. Documented histologically confirmed adenocarcinoma of the prostate. Serum testosterone ≥150 ng/dL.

The full record lists 10 inclusion and 16 exclusion criteria; among the exclusions: prior use of enzalutamide, apalutamide, darolutamide or abiraterone acetate; androgen deprivation therapy (e.g. leuprolide, goserelin, triptorelin, degarelix); cytochrome cyp-17 inhibitors (e.g. ketoconazole).

How the Study Was Run

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

Nothing was hidden in this open-label Leuprolide study: the participants and staff both knew the treatment.

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

It started in 2024-01-01 with completion listed for 2025-01.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Rate of near pathological complete response (pCR) (time frame: 12 weeks).

It also tracked 5 secondary outcomes, for example Negative Margin Rate, Rate of Pathologic T3 disease, Rate of radiographic disappearance of prostate nodules, Proportion of participants receiving adjuvant radiation therapy and Biochemical progression measured by Prostate Specific Antigen (PSA).

What This Means in Plain Language

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

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

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