Can a month of pills boost radiation for prostate cancer?
NCT ID NCT06111781
First seen Jun 26, 2026 · Last updated Sep 15, 2026 · Updated 5 times
Summary
This study tests whether adding a short, 30-day course of the oral hormone drug Relugolix to standard targeted radiation (SBRT) works better than radiation alone for men with intermediate-risk prostate cancer. About 60 men will be randomly assigned to one of the two treatments. The main goal is to see if the combination leads to a lower PSA level after treatment, while also tracking side effects and quality of life.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Relugolix (Orgovyx) and stereotactic body radiotherapy (SBRT)
- What this could lead to
- If successful, this could show that a short 30-day course of Relugolix plus SBRT controls prostate cancer better than SBRT alone, with fewer side effects than longer hormone therapy.
- What could go wrong
- This is a small Phase 2 trial with only 60 participants, so results may not apply to all patients. The short hormone course might not be enough to improve outcomes, and side effects from Relugolix or SBRT are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2024
- Expected to finish
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Feb 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Has histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate 4. Born assigned to Male gender, age 18 and above. Female identifying transgender or gender fluid are allowed on study provided they have not undergone testosterone suppressing therapy and were born with a prostate. 5. Has a serum testosterone at the Screening visit of \>100 ng/dL 6. Has a serum PSA concentration at the Screening visit of \> 0.2 ng/mL 7. Able to swallow pills and take medication orally (no documented inability to eat solids and swallow pills) and be willing to adhere to the daily regimen of medication (if assigned to the experimental arm). 8. For patients of reproductive potential: use of condoms or other methods (including abstinence) to ensure effective contraception with partner during radiotherapy and through 4 months after the last dose of the study drug or radiotherapy 9. Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration 10. Clinical favorable intermediate risk prostate cancer: Gleason score must be Gleason 3+4 with a PSA \< 20 ng/mL, or Gleason 6 (3+3) and PSA \> 10 ng/mL and \< 20 ng mL. 11. Decipher GC score of 0.6 or higher or higher indicating high genomic risk for most recent biopsy 12. Documented prostate volume (by MRI or ultrasound within 120 days or physician attestation within 120 days) \<= 80 cc Exclusion Criteria: 1. Current use of medications that cause QT prolongation 2. Known allergic reactions to relugolix 3. Treatment with another investigational drug or other intervention for prostate cancer within 30 days of enrollment 4. Ulcerative colitis or other inflammatory bowel disease history 5. Connective tissue disease such as lupus, scleroderma, or dermatomyositis 6. GNRH antagonist therapy or SBRT to the prostate are medically contraindicated or not tolerated 7. History of long QT syndrome documented in the medical record 8. The following ECG abnormalities are excluded: 1. Q-wave infarction unless identified 6 or more months before the Screening Visit 2. QT interval corrected for heart rate (QTc) \> 470 msec. If the QTc is prolonged in a patient with a pacemaker, the patient may be enrolled in the study upon discussion with the study PI 3. Congenital long QT syndromeQ 9. History of surgical castration 10. Prior treatment for prostate cancer with surgery or prostate directed radiotherapy
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Dartmouth-Hitchcock Medical Center
RECRUITINGLebanon, New Hampshire, 03756, United States
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Memorial Sloan Kettering Cancer Center
RECRUITINGNew York, New York, 10017, United States
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University of Washington
RECRUITINGSeattle, Washington, 98109, United States
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Yale Cancer Center
RECRUITINGNew Haven, Connecticut, 06520, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A scanner in the operating room could show surgeons exactly where prostate cancer remains
- New PET tracer aims to light up hidden cancer targets
- Can daily adaptive radiotherapy spare healthy tissue in prostate cancer?
- Can a radioactive tracer and MRI reveal prostate Cancer's true extent?
- Five-Fraction radiation plus hormone therapy tested against High-Risk prostate cancer
- Can a 10-Hour eating window fight cancer fatigue?