Can prostate cancer patients skip hormone therapy? new trial tests SBRT alone
NCT ID NCT06397703
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial is for men with unfavorable intermediate-risk prostate cancer. Participants choose between standard care (6 months of hormone therapy plus high-dose radiation) or radiation alone. The goal is to see if skipping hormone therapy still keeps cancer from returning. About 392 men will be followed for up to 5 years with regular biopsies and PSA tests.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Stereotactic body radiation therapy (SBRT) and androgen deprivation therapy (ADT) using leuprolide, degarelix, or relugolix
- What this could lead to
- If successful, this could show that SBRT alone is as effective as SBRT plus hormone therapy for controlling intermediate-risk prostate cancer, potentially sparing many men from hormone side effects.
- What could go wrong
- This is a phase 2 trial with 392 participants, so results are not definitive. The study relies on patient choice rather than random assignment, which may bias outcomes. Long-term follow-up is needed to confirm cancer control.
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
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 392 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Apr 2024
- Expected to finish
-
Apr 2031
An estimate. End dates often move.
- Lead sponsor
-
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
-
18 years and older
- Sex
-
Male participants only
- Healthy volunteers
-
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: * Biopsy proven unfavorable intermediate risk prostate cancer, which includes patients with any one of the following variables: Gleason 4+3 disease; Percent positive cores \> 50% of Gleason 7 disease; 2-3 intermediate risk factors (Gleason 7; PSA 10-20 ng/mL; or T2b-T2c) * Patients must have tissue available for Decipher score testing. Results must be available before start of treatment. * Serum testosterone ≥ 150 ng/dL determined within 2 months prior to enrollment * At least 4 weeks must have elapsed from major surgery * Karnofsky Performance Scale (KPS) ≥ 80% * Prostate size as determined on MRI to be \< 90 cc. Prostate size can be determined on CT scan if MRI is not available * IPSS ≤ 20 * Patient must be available for follow-up. After 2 years of follow-up, upon completion of post-treatment biopsy, telephone and chart review-based follow-up will be acceptable * Adequate hepatic function with serum bilirubin less than or equal to 1.5 times the upper institutional limits of normal (ULN), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) less than or equal to 2.5 x ULN. Patients with a history of Gilbert's syndrome may be enrolled if the total bilirubin is \< 3 mg/dL with a predominance of indirect bilirubin * Adequate renal function with serum creatinine less than or equal to 1.5 x ULN * Adequate hematologic function with absolute neutrophil counts of at least 1,500 cell/mm3 and platelets of at least 100,000 cells/mm3 and hemoglobin value \> 9 g/dL (Note: patients whose anemia has been corrected to a hemoglobin value \> 9 g/dL with blood transfusions are allowed). Exclusion Criteria: * CT or MRI or Positron Emission Tomography (PET) scan evidence of metastatic disease to the bone * Patients with one or more positive lymph nodes considered suspicious as determined by clinical assessment on MRI or CT or PET scan * Prior treatment for prostate cancer, including history of chemotherapy, hormonal therapy within 30 days of enrollment or surgery for prostate cancer (except for prior (transurethral resection of prostate) TURP or greenlight (photoselective vaporization of prostate) PVP which would be allowed) * History of another malignancy within the previous 2 years except for the following: adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, currently in complete remission, or any other cancer that has been in complete remission for at least 3 years * Patients with Crohn's disease or ulcerative colitis
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Prostate cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
-
NYU Langone Health
RECRUITINGNew York, New York, 10016, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Radioactive missile aims at prostate cancer that spread
- New PET tracer targets ACP3 to spot prostate cancer
- Can a One-Week radiation course match four weeks for prostate cancer?
- Can a new PET tracer spot hidden prostate cancer spread?
- Can a gel cushion shield the rectum during prostate radiation?
- A scanner in the operating room could show surgeons exactly where prostate cancer remains