Prostate cancer radiation gets a boost: MR-Guided trial aims to halve recurrence
NCT ID NCT04997018
First seen Jun 25, 2026 · Last updated Sep 03, 2026 · Updated 3 times
Summary
This phase II study tests whether giving an extra-high radiation dose directly to the main prostate tumor, while treating the rest of the prostate with standard SBRT, can reduce the chance of cancer coming back. About 91 men with intermediate-risk prostate cancer will receive five MR-guided radiation sessions. The goal is to lower the 2-year recurrence rate from 20% to 10% with manageable side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- radiation therapy (SBRT with boost dose to the dominant tumor)
- What this could lead to
- If successful, this approach could lower the chance of prostate cancer returning after radiation therapy from 20% to about 10%.
- What could go wrong
- This is a small, early-phase study (91 participants) and the higher radiation dose may increase side effects. Results need confirmation in larger trials.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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91 people
The number who actually took part.
- Started
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Aug 2021
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Intermediate-risk prostate cancer patients will be eligible for this study. Risk groups will be assigned as per NCCN guidelines. Intermediate-risk patients will be defined as: * PSA 10-20 ng/ml or * Gleason score = 7 or * Clinical stage T2b/T2c or * Additionally, patients will be required to meet all of the following criteria: * Age ≥ 18 * Karnofsky Performance Status (KPS) ≥ 80 (Appendix 1) * Prostate size ≤ 80 cc * Presence of a T2-visible prostatic lesion with maximum dimension of ≥ 0.5 cm and no more than one additional disease focus * MRI findings: Lesion may contact the capsular edge, possible extracapsular extension (ECE) permitted * International Prostate Symptom Score ≤ 15 * Satisfy all MRI screening criteria and be willing to fill out the standard MRI screening form Exclusion Criteria: Patient will be excluded if they meet any one of the following criteria: * Gleason score \>7 * PSA \>20 * Prior or concurrent androgen deprivation therapy for prostate cancer MRI findings: suspicious for/probable ECE * MRI findings: \>2 disease foci identifiable * Evidence of metastatic disease on bone scan or MRI/CT * MRI ineligibility due to: the presence of a cardiac pacemaker, defibrillator, or other implanted metallic or electronic device which is considered MR unsafe; severe claustrophobia; inability to lie flat for the duration of the study; etc. * Metallic implant or device in the pelvis that might distort the local magnetic field and compromise quality of mp-MRI * Lateral pelvic separation greater than 50 cm and/or anterior-posterior separation greater than 35 cm which are incompatible with MRCAT reconstruction * Contra-indications to receiving gadolinium contrast * KPS \< 80 * Pelvic or prostate MRI or CT (MRI preferred) evidence of radiographic T3, T4, or N1 disease * Prior history of transurethral resection of the prostate * Prior history of urethral stricture * Prior history of pelvic irradiation * History of inflammatory bowel disease * Unable to give informed consent * Unable to complete quality of life questionnaires * Abnormal complete blood count, including any of the following: * Platelet count less than 75,000/ml * Hb level less than 10 gm/dl * WBC less than 3.5/ml * Abnormal renal function tests (creatinine \> 1.5)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065, United States
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Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920, United States
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Memorial Sloan Kettering at Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645, United States
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Memorial Sloan Kettering at Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748, United States
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Memorial Sloan Kettering at Nassau (Limited Protocol Activities)
Uniondale, New York, 11553, United States
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Memorial Sloan Kettering at Suffolk-Commack (Limited Protocol Activities)
Commack, New York, 11725, United States
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Memorial Sloan Kettering at Westchester (Limited Protocol Activities)
Harrison, New York, 10604, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A scanner in the operating room could show surgeons exactly where prostate cancer remains
- New PET tracer aims to light up hidden cancer targets
- Can daily adaptive radiotherapy spare healthy tissue in prostate cancer?
- Can a radioactive tracer and MRI reveal prostate Cancer's true extent?
- Five-Fraction radiation plus hormone therapy tested against High-Risk prostate cancer
- Can a 10-Hour eating window fight cancer fatigue?