DNA test may help prostate cancer patients avoid radiation side effects
NCT ID NCT04624256
First seen Jun 27, 2026 · Last updated Jul 08, 2026 · Updated 2 times
Summary
This study explores whether a genetic test can identify prostate cancer patients at higher risk for urinary side effects from radiation therapy. Researchers will track side effects in 208 men with early-stage prostate cancer who receive stereotactic radiation. The goal is to see if sharing this genetic information helps doctors and patients choose safer radiation doses.
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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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208 people
The number who actually took part.
- Started
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Nov 2020
- Expected to finish
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Dec 2028
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.
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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: * Histologically confirmed, clinical localized adenocarcinoma of the prostate * No evidence of disease beyond the prostate and/or seminal vesicles (i.e., no suspicious pelvic lymph nodes or presence of metastatic disease outside the pelvis) * Staging workup as recommended by the National Comprehensive Cancer Network (NCCN) on the basis of risk grouping: * Low risk: No staging workup required * Favorable intermediate-risk: computed tomography (CT) abdomen/pelvis only if Memorial Sloan Kettering Cancer Center (MSKCC) nomogram predicts \> 10% probability of lymph node involvement (note: CT simulation scan will count as a CT abdomen/pelvis) * Unfavorable intermediate-risk: technetium bone scan, CT abdomen/pelvis if MSKCC nomogram predicts \> 10% probability of lymph node involvement (note: CT simulation scan will count as a CT abdomen/pelvis) * High-risk: technetium bone scan, CT abdomen/pelvis if MSKCC nomogram predicts \> 10% probability of lymph node involvement (note: CT simulation scan will count as a CT abdomen/pelvis) = * Advanced imaging studies (i.e. prostate specific membrane antigen \[PSMA\] positron emission tomography \[PET\] and Axumin scan) can supplant a bone scan if performed first * Ability to understand, and willingness to sign, the written informed consent Exclusion Criteria: * Patients with neuroendocrine or small cell carcinoma of the prostate * Patients with any evidence of distant metastases. Note, evidence of lymphadenopathy below the level of the renal arteries can be deemed loco regional per the discretion of the investigator * Prior whole-gland cryosurgery, high-intensity focused ultrasound (HIFU) or brachytherapy of the prostate * Prior pelvic radiotherapy * History of Crohn's disease, ulcerative colitis, or ataxia telangiectasia
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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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UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095, United States
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Other studies related to the condition(s) this trial covers.
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