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
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

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