Overview
Brachytherapy for Prostatic Carcinoma Patients
Status:
Active, not recruiting
Active, not recruiting
Trial end date:
2027-09-30
2027-09-30
Target enrollment:
0
0
Participant gender:
Male
Male
Summary
The goal of this clinical research study is to learn if a prostate implant (brachytherapy) can help to control intermediate risk prostate cancer. The safety of this procedure will also be studied. Prostate brachytherapy is performed by inserting permanent seeds (which are radioactive pellets) into your prostate in order to treat the prostate cancer with radiation therapy.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
M.D. Anderson Cancer Center
Criteria
Inclusion Criteria:1. Histologically confirmed adenocarcinoma of the prostate, clinical stage T1c - T2b
(AJCC 6th Edition), N0, M0. Lymph node evaluation by either CT or MRI.
2. Zubrod performance status 0-1.
3. Patient must be greater than or equal to 18 years of age.
4. Patients with intermediate risk prostate cancer as determined by one of the following
combinations: Gleason < 7, PSA 10-15; Gleason 7, PSA must be < 10.
5. Prostate specific antigen (PSA) prior to study entry must be less than or equal to 15
ng/ml.
6. Hormone naive.
7. Prostate volumes by TRUS less than or equal to 60 cc.
8. AUA voiding symptom scores patient.
9. Patients must sign a study-specific informed consent form prior to study entry.
Exclusion Criteria:
1. Stage < T1c, T2c, T3 or T4 disease (AJCC 6th Edition).
2. Lymph node involvement (N1).
3. Evidence of distant metastases (M1).
4. Radical surgery for carcinoma of the prostate, prior pelvic radiation, prior
chemotherapy for prostate cancer, prior TURP, prior cryosurgery, TUNA, TUMT of the
prostate.
5. Active prostatitis.