NCT07635238

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P50-P75 for phase_2 prostate-cancer

Timeline
48mo left

Started May 2026

Geographic Reach
1 country

7 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
May 2026May 2030

Study Start

First participant enrolled

May 28, 2026

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 29, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 9, 2026

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2030

Last Updated

June 9, 2026

Status Verified

May 1, 2026

Enrollment Period

4 years

First QC Date

May 29, 2026

Last Update Submit

June 4, 2026

Conditions

Keywords

Prostate CancerProstate AdenocarcinomaDESTINATION 2Memorial Sloan Kettering Cancer Center26-150

Outcome Measures

Primary Outcomes (1)

  • Number of participants with acute GU toxicities

    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.

    12 weeks from the start of radiation therapy

Study Arms (2)

Group 1: Uniform dose SBRT

ACTIVE COMPARATOR
Radiation: MR-guided Stereotactic Body Radiation Therapy

Group 2: De-escalated dose SBRT

EXPERIMENTAL
Radiation: MR-guided Stereotactic Body Radiation Therapy

Interventions

MR-guided 2 fraction Stereotactic Body Radiation Therapy

Also known as: MR-guided SBRT
Group 1: Uniform dose SBRTGroup 2: De-escalated dose SBRT

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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 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
  • +26 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920, United States

RECRUITING

Memorial Sloan Kettering at Monmouth (Limited Protocol Activities)

Middletown, New Jersey, 07748, United States

RECRUITING

Memorial Sloan Kettering at Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645, United States

RECRUITING

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

Commack, New York, 11725, United States

RECRUITING

Memorial Sloan Kettering at Westchester (Limited Protocol Activities)

Harrison, New York, 10604, United States

RECRUITING

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065, United States

RECRUITING

Memorial Sloan Kettering at Nassau (Limited Protocol Activities)

Uniondale, New York, 11553, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Victoria Brennan, MBBCH BAO

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Victoria Brennan, MBBCH BAO

CONTACT

Zachary Moore, MD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2026

First Posted

June 9, 2026

Study Start

May 28, 2026

Primary Completion (Estimated)

May 28, 2030

Study Completion (Estimated)

May 28, 2030

Last Updated

June 9, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Locations