A Study of Lower Dose Radiation Therapy for People With Prostate Cancer
Dose dE-eScalaTion IN prostATe radIOtherapy usiNg an MR-Linac in 2 Fractions - A Randomized Trial (DESTINATION 2)
1 other identifier
interventional
54
1 country
7
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 prostate-cancer
Started May 2026
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 28, 2026
CompletedFirst Submitted
Initial submission to the registry
May 29, 2026
CompletedFirst Posted
Study publicly available on registry
June 9, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 28, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 28, 2030
June 9, 2026
May 1, 2026
4 years
May 29, 2026
June 4, 2026
Conditions
Keywords
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 COMPARATORGroup 2: De-escalated dose SBRT
EXPERIMENTALInterventions
MR-guided 2 fraction Stereotactic Body Radiation Therapy
Eligibility Criteria
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
Memorial Sloan Kettering at Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering at Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering at Suffolk-Commack (Limited Protocol Activities)
Commack, New York, 11725, United States
Memorial Sloan Kettering at Westchester (Limited Protocol Activities)
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065, United States
Memorial Sloan Kettering at Nassau (Limited Protocol Activities)
Uniondale, New York, 11553, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Victoria Brennan, MBBCH BAO
Memorial Sloan Kettering Cancer Center
Central Study Contacts
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.