Precision radiation boost aims to zap prostate tumors while sparing healthy tissue
NCT ID NCT02307058
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether giving an extra-high dose of radiation to the most aggressive parts of prostate tumors, guided by MRI, can better control cancer while reducing side effects. About 164 men with prostate cancer will receive either the standard radiation or the standard plus a targeted boost. The goal is to improve tumor response and preserve quality of life by protecting nearby organs.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 164 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2015
- Expected to finish
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Jul 2031
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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35 to 85 years
- 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.
Eligibility Criteria: * A. Biopsy confirmed adenocarcinoma (including ductal) of the prostate. * B. T1-T3 disease based on digital rectal exam. * C. No evidence of metastasis by any clinical criteria or available radiographic tests (N0M0 by clinical or imaging criteria). * D. Gleason score 6-10. * E. Androgen deprivation therapy (ADT) is at the discretion of the treating physician; but, must be decided (none, short-term or long-term as counted from the luteinizing hormone-releasing hormone (LHRH) agonist or antagonist injection) prior to enrollment. An anti-androgen (e.g., bicalutamide at 50 mg per day po) is recommended to start prior to LHRH agonist injection (not recommended for LHRH antagonist injection) and is recommended to not be administered for more than 4 months. If ADT is planned, the following restrictions apply: * i. It may be initiated no more than 3 months prior to the signing of consent * ii. It must be started prior to the start of radiotherapy and * iii. The total length planned must be ≤ 30 months * F. Prostate-specific Antigen (PSA) ≤ 100 ng/mL within (+/-) 4 months of signing of consent. If PSA was above 100 and drops to ≤ 100 with antibiotics, this is acceptable for enrollment. * G. Subjects with T3 disease based on digital rectal exam (DRE), Gleason 8-10 or a PSA of \>15 ng/ml, should have a bone scan within (+/-) 4 months of signing of consent that is without evidence of metastasis. A questionable bone scan is acceptable if additional imaging studies (e.g., plain x-rays, CT, or MRI) do not confirm for metastasis. * H. Suspicious peripheral zone or central gland lesion on MP-MRI * i. Peripheral zone: Distinct lesion on dynamic contrast-enhanced MRI (DCE-MRI) with early enhancement and later washout (Note: contrast not required for enrollment), and/or distinct lesion on the ADC map (Value \<1000). * ii. Central gland: A suspicious central gland lesion on MP-MRI must have a distinct lesion on the apparent diffusion coefficient (ADC) map (Value \<1000) * I. No previous pelvic radiotherapy. * J. No previous history of radical/total prostatectomy (suprapubic prostatectomy is acceptable). * K. No concurrent, active malignancy, other than nonmetastatic skin cancer or early stage chronic lymphocytic leukemia (well-differentiated small cell lymphocytic lymphoma). If a prior malignancy is in remission for ≥ 5 years then the patient is eligible. * L. Ability to understand and the willingness to sign a written informed consent document. * M. Zubrod performance status ≤ 2. (Karnofsky or Eastern Cooperative Oncology Group (ECOG) performance status may be used to estimate Zubrod). * N. Willingness to fill out quality of life/psychosocial forms. * O. Age ≥ 35 and ≤ 85 years at signing of consent.
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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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University of Miami
Miami, Florida, 33136, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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