NCT02346253Completed
High-Dose Brachytherapy in Treating Patients With Prostate Cancer
A Phase I/II Study of High-Dose-Rate Brachytherapy as Monotherapy for Prostate Cancer
Source: ClinicalTrials.gov · Last updated 2 Jul 2026
Brief summary (registry, in English)
This trial studies the side effects and how well high-dose brachytherapy works in treating patients with prostate cancer that has not spread to other parts of the body. Brachytherapy is a type of radiation therapy in which radioactive material sealed in needles, seeds, wires, or catheters is placed directly into or near a tumor and may be a better treatment in patients with prostate cancer.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 146 (actual)
- First submitted
- 20 Jan 2015
- Start date
- 13 Jan 2015
- Primary completion date
- 14 Dec 2021
- Lead sponsor
- Stanford University
- Diseases
- Prostate cancer, Childhood cancers
- NCT number
- NCT02346253
What you commit to
- Study type: Interventional
- Participants enrolled: 146
- From 13 Jan 2015 to the primary completion date, 14 Dec 2021
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous chemotherapy for any malignancy, if given within three years of registration
Other illness
- Clinical T4 disease
- History of radical prostatectomy, external beam radiotherapy (EBRT), or BT for prostate cancer
- 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
Other
- PSA \>= 150 ng/mL
- AUA SI \> 20
Who the study is looking for
- 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
Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Stanford University School of Medicine Coordinator of this site? Confirm its status | Stanford | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.