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High-Dose Brachytherapy in Treating Patients With Prostate Cancer
Not Recruiting
Trial ID: NCT02346253
Purpose
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.
Official Title
A Phase I/II Study of High-Dose-Rate Brachytherapy as Monotherapy for Prostate Cancer
Stanford Investigator(s)
Mark Buyyounouski, MD, MS, FASTRO
Professor of Radiation Oncology (Radiation Therapy)
Eligibility
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
Intervention(s):
radiation: Internal Radiation Therapy
drug: Bicalutamide
drug: Leuprolide Acetate
drug: Goserelin Acetate
drug: Triptorelin Pamoate
drug: Degarelix
other: Laboratory Biomarker Analysis
other: Quality-of-Life Assessment
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Matt Morales
650-721-4072