Clinical trial · Observational
Observation of Outcomes and Side Effects of Cesium-131 in Combination With External Beam Radiation for the Treatment of Intermediate to High Risk Prostate Cancer
Dosimetric and Morbidity Outcomes of Cs-131 Brachytherapy in Combination With External Beam Radiation Therapy in Subjects With Intermediate to High Risk Adenocarcinoma of the Prostate: An Observational Study
NCT00621413CI-TRIAL-00051308withdrawnClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study never moved forward due to no accrual
Summary
Brief summary (as posted)
The purpose of this study is to observe PSA response and incidence of side effects in patients diagnosed with intermediate to high risk prostate cancer and treated with Cesium-131 in combination of external beam 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 (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- The analysis of dosimetric data resultant from Cs-131 permanent prostate brachytherapy in combination with external beam radiation therapy in the setting of intermediate to high risk cancer of the prostate.
- timeFrame
- 5 years
- description
- Data collected for analysis will be total therapeutic dose delivered to the prostate by the Cs-131 brachytherapy implant treatment in units of Gy.
Secondary outcomes (2)
- measure
- The analysis of treatment related morbidities following Cs-131 prostate brachytherapy in combination with external beam therapy for intermediate to high risk cancer of the prostate.
- timeFrame
- 5 years
- description
- Data collected for analysis will be the EPIC prostate cancer quality of life questionnaire.
- measure
- The analysis of PSA control rates following Cs-131 prostate brachytherapy in combination with external beam therapy for intermediate to high risk cancer of the prostate.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed adenocarcinoma of the prostate * Clinical stage T1c - T2c (AJCC 6th Edition), NX/N0, M0 * Karnofsky Performance Score of 90 to 100 * Greater than or equal to 18 years of age * Prostate volumes by TRUS ≤ 60 cc * I-PSS score \< 15 (alpha blockers allowed) * Signed study-specific informed consent form prior to study entry Intermediate Risk prostate cancer as determined by the following: * Gleason sum of 7; PSA less than 10.1 ng/ml; Stage T2a or less * Gleason sum 6 or less; PSA \>10.0 and \< 20.1ng/ml; Stage T2a or less * Gleason sum 6 or less; PSA \< 10.1; Stage T2b High risk prostate cancer as determined by the following: * Any Gleason Sum; PSA greater than 20 ng/ml; Stage T2c or less * Gleason Sum \> 7; Any PSA; Stage T2c or less * Any Gleason Sum; Any PSA; Stage T2c * Any two or three intermediate risk factor Exclusion Criteria: * Lymph node involvement (N1) * Evidence of distant metastases (M1) * Any hormonal blockade or therapy that: * Has persisted for more than 6 months by time of protocol screening; OR * Is ongoing within 3 months of study enrollment * Radical surgery for carcinoma of the prostate * Prior pelvic radiation * Previous or concurrent cancers other than basal, in situ, or squamous cell skin cancers unless disease-free for ≥ 5 years * Major medical or psychiatric illness, which in the investigator's opinion, would prevent completion of treatment and would interfere with follow-up * Hip prosthesis * Inability or refusal to provide informed consent
References
Publications (0)
Data not yet available
No reference posted for this study.