High-Dose Brachytherapy in Treating Patients With Prostate Cancer
Trial ID or NCT#
Status
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
Eligibility 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
- - 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
Investigator(s)
Contact us to find out if this trial is right for you.
Contact
Matt Morales
650-721-4072
View on ClinicalTrials.gov