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)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether giving less radiation to some parts of the prostate can reduce side effects compared with giving the same dose to the whole prostate. It is for adults with prostate cancer that can be seen on MRI scans and has not spread to lymph nodes or distant parts of the body.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 18 or older, able to care for yourself, and out of bed or a chair for at least half of waking hours.
- Have prostate adenocarcinoma confirmed by a tissue sample, with Grade Group 1, 2, or 3. Grade groups describe how abnormal the cancer cells look.
- Have a PSA blood test result below 20 ng/mL before starting hormone treatment, if used. Cancer stage must be TX, T1, or T2 on a rectal exam, and no higher than T3a on MRI.
- Have an MRI within 12 months before study group assignment. All visible tumors must have a PI-RADS score of 3–5, which rates how likely an area is to be cancer, and be clearly outlined on the scan.
- Have MRI-visible tumors confirmed as cancer by tissue samples, smaller than 2.5 cm, and safe to receive extra radiation. The prostate must be no larger than 90 mL.
- Meet the study’s blood count, kidney, liver, and heart health requirements.
- Understand and sign the consent form, and agree to complete study questionnaires.
- Agree to use birth control during treatment and for 1 year afterward, if this applies to you.
Who can't join
- Cancer has spread to lymph nodes or distant parts of the body, or Grade Group 3 cancer is found outside the tumor area seen on MRI.
- Need more than 6 months of hormone treatment to lower male hormones because of the cancer’s features.
- Cannot safely have an MRI, such as because of certain implants or a fear of enclosed spaces.
- Have had radiation to the prostate, prostate surgery, or another treatment aimed at cancer in the prostate.
- Have an active infection that needs antibiotics given by injection or through a vein.
- Have severe urinary symptoms that make the planned radiation unsafe, or a urinary symptom score called IPSS above 19.
- Have another illness, such as inflammatory bowel disease, that raises the risk of serious side effects or prevents long-term follow-up.
- Have another cancer whose course or treatment could affect the study’s safety or results.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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 sites (7)
NJ
- Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) · Basking Ridge, NJ 07920Victoria Brennan, MBBCH BAO · Study contact · 212-639-8904 · brennanv@mskcc.orgMore trials in Basking Ridge
- Memorial Sloan Kettering at Monmouth (Limited Protocol Activities) · Middletown, NJ 07748Victoria Brennan, MBBCH BAO · Study contact · 212-639-8904 · brennanv@mskcc.orgMore trials in Middletown
- Memorial Sloan Kettering at Bergen (Limited Protocol Activities) · Montvale, NJ 07645Victoria Brennan, MBBCH BAO · Study contact · 212-639-8904 · brennanv@mskcc.orgMore trials in Montvale
NY
- Memorial Sloan Kettering at Suffolk-Commack (Limited Protocol Activities) · Commack, NY 11725Victoria Brennan, MBBCH BAO · Study contact · 212-639-8904 · brennanv@mskcc.orgMore trials in Commack
- Memorial Sloan Kettering at Westchester (Limited Protocol Activities) · Harrison, NY 10604Victoria Brennan, MBBCH BAO · Study contact · 212-639-8904 · brennanv@mskcc.orgMore trials in Harrison
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) · New York, NY 10065Victoria Brennan, MBBCH BAO · Study contact · 212-639-8904More trials in New York
- Memorial Sloan Kettering at Nassau (Limited Protocol Activities) · Uniondale, NY 11553Victoria Brennan, MBBCH BAO · Study contact · 212-639-8904 · brennanv@mskcc.orgMore trials in Uniondale