Could less radiation be better for prostate cancer?
NCT ID NCT07635238
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is for men with low- to intermediate-risk prostate cancer. It compares giving a lower radiation dose to some parts of the prostate versus the same dose to the whole prostate. The goal is to see if the lower dose reduces short-term urinary side effects. About 54 people will take part.
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 54 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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May 2030
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: * Documentation of Disease o Patients must have pathologically confirmed prostate adenocarcinoma. * Definition of Disease * Grade Group (GG) 1, 2, or 3. * PSA less than 20 ng/mL prior to starting ADT, if used. * Clinical stage of TX, T1 or T2 on digital rectal examination. May have up to radiological stage T3a on MRI. MRI must be performed within 12 months of randomization. * MRI-visible tumor(s), all having PIRADS v2.1 scores of 3, 4, or 5. Each tumor should be able to be delineated on T2 and diffusion-weighted imaging (DWI) +/- dynamic contrast-enhanced imaging (DCE). * Tumor nodule visible on MRI should be considered able to be boosted by treating clinician (ie meet urethral constraints while maintaining mandatory GTV coverage) and \<2.5cm in maximal dimension. * The MRI-defined lesion must be confirmed as malignant on biopsies (Grade group 1, 2, or 3). * Patients can be concurrently treated with androgen deprivation therapy (ADT) if this would be standard of care. LHRH analogues, LHRH agonists or Bicalutamide are permitted. ADT is not mandatory where this would usually be omitted. Patients needing greater than 6 months of ADT due to disease parameters should be excluded. * No high grade disease (GG3) occult to MRI-defined lesion. As a guide, any pathology for which you would consider surveillance (e.g. GG1, low volume GG2) is allowed outside of the MRI-defined area. * No contraindications to MRI (e.g. pacemaker, potentially mobile metal implant, claustrophobia). * Prostate volume less than or equal to 90mL. * No evidence of nodal or distant metastatic disease. * Prior Treatment o No history of previous radiation to the prostate, prostate surgery (including transurethral resection of the prostate (TURP)), or other local prostate cancer treatments. * Age ≥ 18 * ECOG Performance Status of ≤ 2 (See Appendix I for performance status criteria) * Required Organ Function * Adequate hematologic function defined as follows: * Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3 * Platelets ≥ 100,000 cells/mm3 * Hemoglobin ≥ 8 g/dl * Adequate renal function defined as follows: * Creatinine clearance (CrCL) of ≥30 mL/min by the Cockcroft-Gault formula: CrCl (mL/min) = \[140 - age (years)\] x weight (kg) / 72 x creatinine (mg / dL) {x 0.85 for female patients} * Adequate hepatic function defined as follows: * Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (patients with known Gilbert's disease who have bilirubin level ≤ 3 x ULN may be enrolled) * AST and ALT ≤3 x institutional ULN * Adequate cardiac function defined as follows: * Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. * To be eligible for this trial, patients should be class 2B or better (see Appendix II: New York Heart Association (NYHA) Functional Classification). * Comorbid Conditions * No active infection requiring parenteral antibiotic(s). * Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. * No severe GU symptoms that would preclude extreme hypofractionation per the discretion of the treating physician. * No IPSS Score greater than 19. * No comorbidities which predispose to significant toxicity (e.g. inflammatory bowel disease) or preclude long term follow up. * Ability of the participant to understand and the willingness to sign a written informed consent form. * Willing to consent to contraception during and for 1 year after treatment when applicable. * Ability/willingness to comply with the patient reported outcome questionnaires schedule throughout the study.
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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
7 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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Memorial Sloan Kettering Cancer Center (All Protocol Activities)
RECRUITINGNew York, New York, 10065, United States
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Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
RECRUITINGBasking Ridge, New Jersey, 07920, United States
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Memorial Sloan Kettering at Bergen (Limited Protocol Activities)
RECRUITINGMontvale, New Jersey, 07645, United States
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Memorial Sloan Kettering at Monmouth (Limited Protocol Activities)
RECRUITINGMiddletown, New Jersey, 07748, United States
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Memorial Sloan Kettering at Nassau (Limited Protocol Activities)
RECRUITINGUniondale, New York, 11553, United States
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Memorial Sloan Kettering at Suffolk-Commack (Limited Protocol Activities)
RECRUITINGCommack, New York, 11725, United States
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Memorial Sloan Kettering at Westchester (Limited Protocol Activities)
RECRUITINGHarrison, New York, 10604, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New PET tracer targets ACP3 to spot prostate cancer
- Can a One-Week radiation course match four weeks for prostate cancer?
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- Can a gel cushion shield the rectum during prostate radiation?
- A scanner in the operating room could show surgeons exactly where prostate cancer remains