Recruiting

Comparing short versus long hormone therapy with radiation for prostate cancer

Plain-English translation of NCT04242017 on ClinicalTrials.gov ↗ · Source last updated December 2023 · Translation generated June 2026 · How we translate trials

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Phase 3 — Testing in thousands of people, comparing the treatment against what doctors currently use. This is the last big step before approval.

What is this trial?

After prostate surgery, some men's cancer comes back as rising PSA levels. This trial is testing whether receiving radiation therapy combined with androgen deprivation therapy (ADT)—medication that blocks male hormones—for 24 months works better than receiving the same radiation with only 6 months of this medication. The goal is to see which approach prevents the cancer from spreading to distant parts of the body.

When prostate cancer returns after surgery, radiation therapy with hormone-blocking medication can help prevent it from spreading. However, doctors don't yet know whether giving this medication for six months or two years works better, so this trial will compare the two approaches.

Do you qualify?

You likely qualify if…

you have had prostate surgery with removal of pelvic lymph nodes, and those lymph nodes did not contain cancer
you have a rising PSA level after surgery (0.2 or higher, or 0.15 or higher if your cancer was very aggressive or the surgery margins were positive)
you have normal testosterone levels above 150 ng/dL
you are in good enough health to live at least 5 more years
you have signed informed consent to participate

You likely don't qualify if…

you have cancer in your pelvic lymph nodes from your original surgery
you have distant metastasis (cancer that has already spread beyond the prostate area)
you have had previous radiation therapy that would overlap with this treatment
you have certain bowel conditions like ulcerative colitis or Crohn's disease, which make radiation unsafe
you are already taking hormone-blocking medication or other drugs that affect PSA levels

What participation looks like

You will receive radiation therapy to the prostate bed at a dose of 70 Gray, given in small daily doses over several weeks. You will also be randomly assigned to receive hormone-blocking medication (ADT) for either 6 months or 24 months. You'll have regular visits to monitor your PSA levels, side effects, and overall health. The trial will follow you to see whether cancer spreads to distant parts of your body and compare outcomes between the two groups.

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

Trial locations(3 sites)

Belgium

AZ Maria Middelares, Ghent

UZ Gent, Ghent

UZ Leuven, Leuven