Shorter radiation blasts prostate tumors in early trial
NCT ID NCT03269422
First seen Jun 27, 2026 · Last updated Jul 31, 2026 · Updated 1 time
Summary
This early-phase study tests a new, ultra-short course of radiation therapy for men with intermediate-risk prostate cancer. The treatment uses MRI guidance to precisely target the prostate and the main tumor inside it. The goal is to see if this approach is safe and practical, with a focus on limiting side effects.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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35 people
The number who actually took part.
- Started
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Aug 2017
- Finished
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Jul 2026
- 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.
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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 * Additionally, patients will be required to meet the following criteria: * Age \>18 * KPS \> 80 * Prostate size \< 60cc * Presence of a prostatic lesion with maximum dimension of \>/= 0.5cm and no more than two additional disease foci, each with a maximum dimension less than that of the dominant lesion. * International Prostrate Symptom Score \< 15 * Subjects must fill out the standard MRI screening form and satisfy all MRI screening criteria Exclusion Criteria: * Prior androgen deprivation therapy for prostate cancer * 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 or inability to lie flat for the duration of the study, etc. * Metallic hip implant, 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 MRI or CT (MRI preferred) evidence of radiographic T3, T4 or N1 disease. * Prior history of transurethral resection of the prostate * Prior history of chronic prostatitis * 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. 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 Basking Ridge (Consent only and follow up)
Basking Ridge, New Jersey, 07920, United States
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Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645, United States
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Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
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Memorial Sloan Kettering Commack
Commack, New York, 11725, United States
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Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748, United States
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Memorial Sloan Kettering Nassau (Consent and follow up)
Uniondale, New York, 11553, United States
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Memorial Sloan Kettering Westchester
East White Plains, 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?