Prostate CancerPhase 2NCT07635238
A Study of Lower Dose Radiation Therapy for People With Prostate Cancer
A Phase 2 study testing MR-guided Stereotactic Body Radiation Therapy in people with Prostate Cancer and Prostate Adenocarcinoma, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Prostate Adenocarcinoma
- What is being tested?
- MR-guided Stereotactic Body Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 7 sitesUnited States
- Study dates
- 28 May 2026to 28 May 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
None listed.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
Victoria Brennan, MBBCH BAO, 212-639-8904, brennanv@mskcc.org
- Recruiting
Memorial Sloan Kettering at Suffolk-Commack (Limited Protocol Activities)
Commack, New York, 11725
Victoria Brennan, MBBCH BAO, 212-639-8904, brennanv@mskcc.org
- Recruiting
Memorial Sloan Kettering at Westchester (Limited Protocol Activities)
Harrison, New York, 10604
Victoria Brennan, MBBCH BAO, 212-639-8904, brennanv@mskcc.org
- Recruiting
Memorial Sloan Kettering at Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748
Victoria Brennan, MBBCH BAO, 212-639-8904, brennanv@mskcc.org
- Recruiting
Memorial Sloan Kettering at Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645
Victoria Brennan, MBBCH BAO, 212-639-8904, brennanv@mskcc.org
- Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Victoria Brennan, MBBCH BAO, 212-639-8904
- Recruiting
Memorial Sloan Kettering at Nassau (Limited Protocol Activities)
Uniondale, New York, 11553
Victoria Brennan, MBBCH BAO, 212-639-8904, brennanv@mskcc.org
About this study
Official title: Dose dE-eScalaTion IN prostATe radIOtherapy usiNg an MR-Linac in 2 Fractions - A Randomized Trial (DESTINATION 2)
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
- Being tested
- MR-guided Stereotactic Body Radiation Therapy
- Keywords
- Prostate Cancer, Prostate Adenocarcinoma, DESTINATION 2, Memorial Sloan Kettering Cancer Center, 26-150
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR-guided Stereotactic Body Radiation TherapyRadiation
Also called MR-guided SBRT
MR-guided 2 fraction Stereotactic Body Radiation Therapy
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Uniform dose SBRT | Active comparator | Not described Receives: Radiation: MR-guided Stereotactic Body Radiation Therapy |
| Group 2: De-escalated dose SBRT | Experimental | Not described Receives: Radiation: MR-guided Stereotactic Body Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks from the start of radiation therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start28 May 2026
- Primary completion28 May 2030 (estimated)
- Study completion28 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Victoria Brennan, MBBCH BAO, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07635238
- Sponsor's protocol ID
- 26-150
- Status last verified
- Jun 2026
- First submitted
- 29 May 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose dE-eScalaTion IN prostATe radIOtherapy usiNg an MR-Linac in 2 Fractions - A Randomized Trial (DESTINATION 2)
- ClinicalTrials.gov ID
- NCT07635238
- Acronym / sponsor ID
- 26-150
- Conditions
- Prostate Cancer, Prostate Adenocarcinoma
- Keywords
- Prostate Cancer, Prostate Adenocarcinoma, DESTINATION 2, Memorial Sloan Kettering Cancer Center, 26-150
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 28 May 2026 (actual)
- Primary completion
- 28 May 2030 (estimated)
- Study completion
- 28 May 2030 (estimated)
- First posted
- 9 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (41 listed)
- Documentation of Disease
- o Patients must have pathologically confirmed prostate adenocarcinoma.
- Definition of 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MR-guided Stereotactic Body Radiation TherapyAlso: MR-guided SBRTMR-guided 2 fraction Stereotactic Body Radiation Therapy | Radiation | Group 1: Uniform dose SBRT, Group 2: De-escalated dose SBRT |
Primary outcome
Number of participants with acute GU toxicities
Time frame: 12 weeks from the start of radiation therapy
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Victoria Brennan, MBBCH BAO principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MR-guided Stereotactic Body Radiation Therapy in people with Prostate Cancer and Prostate Adenocarcinoma, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 41 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Victoria Brennan, MBBCH BAO (212-639-8904, brennanv@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with acute GU toxicities (time frame: 12 weeks from the start of radiation therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.