High-Dose Brachytherapy in Treating Patients With Prostate Cancer

Not Recruiting

Trial ID: NCT02346253


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
Mark Buyyounouski, MD, MS, FASTRO

Professor of Radiation Oncology (Radiation Therapy)


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


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

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