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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)

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07635238
Enrollment
54
Registered
2026-06-09
Start date
2026-05-28
Completion date
2030-05-28
Last updated
2026-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Adenocarcinoma, Prostate Cancer

Keywords

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

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.

Interventions

RADIATIONMR-guided Stereotactic Body Radiation Therapy

MR-guided 2 fraction Stereotactic Body Radiation Therapy

Sponsors

Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Number of participants with acute GU toxicities12 weeks from the start of radiation therapyTo 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.

Countries

United States

Contacts

CONTACTVictoria Brennan, MBBCH BAO
brennanv@mskcc.org212-639-8904
CONTACTZachary Moore, MD, PhD
MooreZ@mskcc.org212-639-5803
PRINCIPAL_INVESTIGATORVictoria Brennan, MBBCH BAO

Memorial Sloan Kettering Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 19, 2026