New radiation approach aims to tame prostate cancer with fewer side effects
NCT ID NCT02346253
First seen Jun 27, 2026 · Last updated Jul 02, 2026 · Updated 1 time
Summary
This study tests a type of radiation called high-dose brachytherapy for men with prostate cancer that hasn't spread. Doctors place tiny radioactive sources directly into the prostate to deliver a strong dose to the tumor while sparing nearby healthy tissue. The goal is to control the cancer and reduce side effects. About 146 men with early to moderate-stage prostate cancer are taking part.
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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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146 people
The number who actually took part.
- Started
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Jan 2015
- Finished
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May 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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Children (under 18), adults (18 to 64) and older adults (65 and over)
- 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: * Documented pathologic confirmation of prostate adenocarcinoma * Clinical T-classification T1-3 * PSA \< 150 ng/mL * Gleason score 6-10 * Clinically negative lymph nodes as established by abdomino-pelvic CT. CT only for clinical classification of T3 (with contrast if renal function is acceptable; a non-contrast CT is permitted if the patient is not a candidate for contrast), magnetic resonance imaging (MRI), nodal sampling, or dissection. Patients with lymph nodes equivocal or questionable by imaging are eligible if those nodes are \<1 cm in short axis diameter. \[56\] * No evidence of bone metastases (M0) on bone scan, only for PSA \>20 ng/mLor Gleason ≥8, (NaF PET/CT is an acceptable substitute). Equivocal bone scan findings are allowed if plain films and/or MRI are negative for definite metastases. * American Urological Association Symptom Index (AUA SI) =\< 20 Exclusion Criteria: * Clinical T4 disease * PSA \>= 150 ng/mL * AUA SI \> 20 * History of radical prostatectomy, external beam radiotherapy (EBRT), or BT for prostate cancer * Previous chemotherapy for any malignancy, if given within three years of registration * History of rectal surgery * History of rectal fistula * History of inflammatory bowel disease * Severe, active co-morbidity, defined as follows: * Unstable angina and/or congestive heart failure requiring hospitalization within the last six months * Transmural myocardial infarction within the last six months
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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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Stanford University, School of Medicine
Stanford, California, 94305, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a High-Tech radiation beam hit prostate tumors without harming healthy tissue?
- Can 3D imaging make prostate radiation more precise and worth the cost?