Recruiting
Phase 2

Radiation Therapy

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT07635238

Conditions

Prostate Cancer

Prostate Adenocarcinoma

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MR-guided Stereotactic Body Radiation Therapy

Study Details

Brief summary:

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.

Conditions

Prostate Cancer

Prostate Adenocarcinoma

Study ID

NCT07635238

Start date

May 28, 2026

Status verified date

Jun, 2026

Completion date

May 28, 2030

Anticipated

Primary completion date

May 28, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

54 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Group 1: Uniform dose SBRT

experimental: Group 2: De-escalated dose SBRT

Interventions

MR-guided Stereotactic Body Radiation Therapy

MR-guided 2 fraction Stereotactic Body Radiation Therapy

Primary outcome measure

  • Number of participants with acute GU toxicities [ Time Frame: 12 weeks from the start of radiation therapy ]

Central Contacts and Locations

Central contacts

Victoria Brennan, MBBCH BAO

212-639-8904brennanv@mskcc.org

Zachary Moore, MD, PhD

212-639-5803MooreZ@mskcc.org

Locations

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Victoria Brennan, MBBCH BAO

212-639-8904brennanv@mskcc.org

Memorial Sloan Kettering at Monmouth (Limited Protocol Activities)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Victoria Brennan, MBBCH BAO

212-639-8904brennanv@mskcc.org

Memorial Sloan Kettering at Bergen (Limited Protocol Activities)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Victoria Brennan, MBBCH BAO

212-639-8904brennanv@mskcc.org

Memorial Sloan Kettering at Suffolk-Commack (Limited Protocol Activities)

Recruiting

Commack, New York, United States, 11725

Contacts

Victoria Brennan, MBBCH BAO

212-639-8904brennanv@mskcc.org

Memorial Sloan Kettering at Westchester (Limited Protocol Activities)

Recruiting

Harrison, New York, United States, 10604

Contacts

Victoria Brennan, MBBCH BAO

212-639-8904brennanv@mskcc.org

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

Recruiting

New York, New York, United States, 10065

Contacts

Victoria Brennan, MBBCH BAO

212-639-8904

Memorial Sloan Kettering at Nassau (Limited Protocol Activities)

Recruiting

Uniondale, New York, United States, 11553

Contacts

Victoria Brennan, MBBCH BAO

212-639-8904brennanv@mskcc.org

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Jun 18, 2026

Last verified

Jun, 2026

Keywords

  • Prostate Cancer
  • Prostate Adenocarcinoma
  • DESTINATION 2
  • Memorial Sloan Kettering Cancer Center
  • 26-150

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-06-18.