Take hormone therapy combined with radiation treatment for prostate cancer

What is this trial?

This trial is testing whether men with prostate cancer that has returned after surgery benefit more from 6 months or 24 months of hormone-blocking therapy (using LHRH analogues and bicalutamide) combined with radiation treatment to the pelvis. Right now, doctors don't have clear evidence about which duration of this medication is best, so this study will compare the two approaches in nearly 550 patients across multiple hospitals.

After prostate surgery, some men's cancer comes back (detected by rising PSA blood levels), but doctors aren't sure whether shorter or longer courses of hormone-blocking medication work better alongside radiation. This trial aims to settle that question so all patients get the most effective treatment.

Do you qualify?

You likely qualify if…

you have been diagnosed with prostate cancer and had surgery to remove your prostate
your PSA blood level has risen after surgery (signs of cancer returning), confirmed by at least two tests
you are classified as intermediate or high-risk based on factors like PSA doubling time, Gleason score, and stage
you have normal testosterone levels (above 150 ng/dL)
you have a life expectancy of at least 5 years and are in generally good health

You likely don't qualify if…

you have cancer spread to your lymph nodes at the time of surgery
imaging scans show cancer has spread to distant parts of your body
you have already received radiation to your pelvis
you are currently taking hormone-blocking drugs or other medications that affect PSA levels
you are unable to understand the treatment plan or provide informed consent

What participation looks like

You will be randomly assigned to receive either 6 months or 24 months of hormone-blocking injections (plus a short course of a tablet) combined with radiation therapy to your pelvis. You'll visit the hospital regularly for injections, radiation sessions, and blood tests to monitor your PSA levels and overall health. The study will follow you over time to see which treatment approach works better at preventing cancer from returning.

AI-generated summary from trial data · Jul 12, 2026 · Not medical advice

Key details

Phase

Large-scale testing

Sponsor

Instituto de Investigación en Oncología Radioterápica - Fundación Española de Oncología Radioterápic

Enrollment target

~534 participants

Started

March 2023

Primary completion

December 2023

This trial's estimated completion date has passed — the record may not be fully up to date.

Age range

18 Years and older

Last updated on clinicaltrials.gov in November 2023.

Contact the research team directly

Reach out to the team running this trial. Response times vary — some teams are faster than others.

Central contact

Pablo Raña, PhD

Instituto de Investigación en Oncología Radioterápica - Fundación Española de Oncología Radioterápic

Interested in joining?

Tell us you're interested and we'll help connect you with the research team. We'll walk you through what to expect first — no email needed to get started.

Short versus long-term hormone therapy with radiation for prostate cancer recurrence

What is this trial?

Do you qualify?

What participation looks like

Trial locations(17 sites)