High-Dose Brachytherapy in Treating Patients With Prostate Cancer

• Status: Suspended
• Trial end date: 2026-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

This phase I/II 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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Collaborator: National Cancer Institute (NCI)
• Treatments: Bicalutamide; Goserelin; Leuprolide; Triptorelin Pamoate

Criteria

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