Efficacy, Safety, and Pharmacokinetics of FP-[amount hidden] in Patients With Advanced Prostate Cancer

What Was Tested

The trial (phase 3) is built around Triptorelin.

This is a study in male patients with advanced prostate cancer who are eligible for androgen ablation therapy.

The study duration will be up to 48 weeks.

Eligibility will be assessed during a screening period of up to 28 days.

It had 1 arm (groups): FP-014 (experimental).

The registry classes the interventions as drug.

More on the Plan

The acute-on-chronic (surge) effect of serum testosterone and LH levels will also be monitored in all patients.

All treatment emergent adverse events (TEAEs), including adverse events of interest (AEoI), that occur during the study period and serious adverse events (SAEs) that occur during the study period will be recorded in the eCRFs and followed until they are resolved or considered stable.

In addition, all SAEs will be recorded and reported as required by local and international regulatory requirements.

Other safety assessments and their results including safety clinical laboratory parameters, vital signs, physical examination, resting 12-lead electrocardiogram (ECG), injection site reactions and bone pain (assessed using visual analog scale \[VAS\]) will also be recorded in the eCRF.

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: Males aged ≥ 18 years old at Screening. Histologically confirmed carcinoma of the prostate at the time of Screening. Metastatic or biochemically recurrent prostate cancer disease at Screening. Patient agrees to use male contraceptive methods during the study. Patients judged by the attending physician and/or Principal Investigator to be a candidate for androgen ablation therapy.

The full record lists 26 inclusion and 24 exclusion criteria; among the exclusions: receipt of chemotherapy, immunotherapy, cryotherapy, radiotherapy, or anti- androgen therapy within 8 weeks prior to screening, for treatment of carcinoma of the prostate; receipt of any luteinizing hormone-releasing hormone (lh-rh) suppressive therapy within 6 months of the screening visit; receipt of any vaccination (including influenza) within 2 weeks of the screening visit.

How the Study Was Run

Design: single-group and open-label.

Everyone knew when Triptorelin 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 2025-06-01 with completion listed for 2027-11-30.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Primary Endpoints. Primary Endpoints (time frame: from Week 4 (Day 28 ± 1 day) through Week 48 (Day 336 ± 5 days)).

It also tracked 7 secondary outcomes, for example Secondary Endpoints, Secondary Endpoints, Secondary Endpoints, Secondary Endpoints, Secondary Endpoints and Secondary Endpoints.

What This Means in Plain Language

Put simply, this is a phase 3 trial of Triptorelin in people.

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

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