Clinical trial · Interventional
Brachytherapy for Prostatic Carcinoma Patients
Transperineal Interstitial Permanent Brachytherapy Alone for Selected Patients With Intermediate Risk Prostatic Carcinoma
NCT00525720CI-TRIAL-00105046active not recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 15, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260915-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Brachytherapy | Drug | — | UNRESOLVED |
| Questionnaire | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Brachytherapy - Participants with < 35% biopsy core
- description
- Brachytherapy implant procedure lasting 1-2 hours. Questionnaires taking 30 total minutes.
- interventionNames
- Drug: Brachytherapy
- Behavioral: Questionnaire
- type
- EXPERIMENTAL
- label
- Brachytherapy - Participants with > 35% biopsy core
- description
- Brachytherapy implant procedure lasting 1-2 hours. Questionnaires taking 30 total minutes.
- interventionNames
- Drug: Brachytherapy
- Behavioral: Questionnaire
Primary outcomes (1)
- measure
- Biochemical prostate specific antigen (PSA) progression
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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 \</= 15 (alpha blockers allowed); this is completed by the 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.
References
Publications (0)
Data not yet available
No reference posted for this study.