High-Dose Brachytherapy in Treating Patients With Prostate Cancer

Trial ID or NCT#

NCT02346253

Status

not recruiting iconNOT RECRUITING

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

Sexes Eligible for Study: Male
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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
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Investigator(s)

Mark Buyyounouski, MD, MS, FASTRO
Mark Buyyounouski, MD, MS, FASTRO
Radiation oncologist, Genitourinary specialist
Professor of Radiation Oncology (Radiation Therapy)

Contact us to find out if this trial is right for you.

Contact

Matt Morales
650-721-4072

View on ClinicalTrials.gov