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

Recruiting now · Phase 2

Conditions studied: Prostate Cancer, Prostate Adenocarcinoma

In brief

The purpose of this study is to see whether giving a lower (de-escalated) dose of radiation therapy to some parts of the prostate can reduce side effects compared to giving the same (uniform) dose of radiation therapy to the whole prostate.

Key facts

Study ID

NCT07635238

Run by

Memorial Sloan Kettering Cancer Center

People needed

54

Starts

2026-05-28

Expected to finish

2030-05-28

Last updated by the study team

2026-06-18

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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:

Where it is running

• Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) — Basking Ridge, New Jersey, United States (enrolling)
• Memorial Sloan Kettering at Monmouth (Limited Protocol Activities) — Middletown, New Jersey, United States (enrolling)
• Memorial Sloan Kettering at Bergen (Limited Protocol Activities) — Montvale, New Jersey, United States (enrolling)
• Memorial Sloan Kettering at Suffolk-Commack (Limited Protocol Activities) — Commack, New York, United States (enrolling)
• Memorial Sloan Kettering at Westchester (Limited Protocol Activities) — Harrison, New York, United States (enrolling)
• Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York, United States (enrolling)
• Memorial Sloan Kettering at Nassau (Limited Protocol Activities) — Uniondale, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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