Overview

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