Study to Assess the Efficacy of Brachytherapy With or Without Hormone Therapy, Using Triptorelin [amount hidden] in Patients With Recurrence of Prostate Cancer

What Was Tested

The trial (phase 2) is built around Triptorelin.

It had two arms (groups): one (experimental) and Brachytherapy (active comparator).

The registry classes the interventions as drug and radiation.

More on the Plan

This was a proof-of-concept, prospective, parallel, multicentre, randomised and open-label trial, including a follow-up of all subjects conducted at 11 centres in Spain.

Study visits included an inclusion visit (Visit 1), a treatment administration visit (Visit 2), and 9 follow-up visits (Visit 3 to Visit 11) from 3 to 60 months after study treatment administration.

All of the procedures performed at these visits were in accordance with routine clinical practice.

Visit 2 included a review of the eligibility criteria, recording of concomitant medications and adverse events (AEs) and study drug administration.

Who Took Part

The registry lists 32 actual participants took part.

It was open to men only aged from 18 years up to 75 years.

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

Examples of who could join: A history of prostate cancer (T1-T2-T3 N0 M0), confirmed through histopathology and initially treated with radiotherapy. Age ≤ 75 years. Biochemical failure due to Phoenix criteria (nadir + 2) and local recurrence of the initial prostate cancer, confirmed by prostate biopsy, with neither regional involvement nor distant metastases. Late local recurrence of the initial prostate cancer. A recurrence is late when it appears after longer than 18 months post-radiotherapy. PSA \< 10 ng/mL at the time of recurrence.

The full record lists 16 inclusion and 11 exclusion criteria; among the exclusions: evidence of metastatic disease; previous evidence of hormone-resistant cancer; lack of availability for performing regular follow-up.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Triptorelin and who got the comparison, which limits bias.

The Triptorelin group and the comparison group ran side by side rather than switching.

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

It started in 2011-11 with completion listed for 2014-12.

It ran at 11 sites in Spain (11).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Biochemical Failure-free Survival (BFFS) (time frame: Up to 5 years).

It also tracked 6 secondary outcomes, for example Time to Progression, BFFS Percentage 5 Years From Treatment Initiation, Overall Survival, Number of Participants With Change in Total Serum Testosterone Levels From Baseline at 3, 6 and 12 Months and Number of Participants With Change in Total Serum PSA Levels From Baseline at 3, 6 and 12 Months.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Triptorelin in 32 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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