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

Contact

Matt Morales
650-721-4072

View on ClinicalTrials.gov