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Lower Dose Radiation Therapy for Prostate Cancer

This study is looking at a new way to give radiation therapy for prostate cancer. It's called MR-guided Stereotactic Body Radiation Therapy (SBRT), and it involves giving a lower dose of radiation to some parts of the prostate. The goal is to see if this approach can reduce side effects compared to giving the same dose to the whole prostate. You might be able to join if you are a man, 18 or older, with prostate adenocarcinoma (a type of prostate cancer) that meets specific criteria, including certain Grade Groups and PSA levels. The study will measure how many participants experience acute genitourinary (urinary and genital) side effects 12 weeks after starting radiation therapy. The current status of this study is unclear, and it plans to enroll 54 participants.

Study design
This is an interventional study that plans to enroll 54 participants. It is testing MR-guided Stereotactic Body Radiation Therapy.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint measures side effects at 12 weeks from the start of radiation therapy.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07635238

A Study of Lower Dose Radiation Therapy for People With Prostate Cancer

Recruiting
PHASE2Ages 18+InterventionalTreatment
Memorial Sloan Kettering Cancer Center
~54 participants
Updated 2026-06-18 on ClinicalTrials.gov
What's tested:MR-guided Stereotactic Body Radiation Therapy

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with acute GU toxicities
Measured over 12 weeks from the start of radiation therapy

Conditions

Prostate Cancer
Prostate Adenocarcinoma

Explore related trials

Prostate AdenocarcinomaProstate Carcinoma

Where it's being run

7 sites across 2 states
New York4
New Jersey3

Study leadership

  • Victoria Brennan, MBBCH BAO · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

Who to contact

Victoria Brennan, MBBCH BAO
[email protected]
212-639-8904
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Documentation of Disease
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
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:
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.

What this trial measures

  • Number of participants with acute GU toxicities12 weeks from the start of radiation therapy

    To estimate the absolute and relative risk of acute GU toxicity (CTCAE v5) when delivering dose de-escalated or uniform dose prostate SBRT, both using a 2-fraction regimen.