Clinical trial · Interventional
Study of High-dose Rate (HDR) Monotherapy for Low and Intermediate Risk Prostate Cancer
Phase II Study of High-dose Rate (HDR) Monotherapy for the Treatment of Low and Intermediate Risk Prostate Cancer
NCT02077335CI-TRIAL-00074190unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine the clinical efficacy and toxicity of High-dose rate (HDR) brachytherapy as monotherapy for the treatment of low risk and intermediate risk prostate cancer.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HDR brachytherapy monotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HDR brachytherapy monotherapy
- description
- Radiation therapy: Treatment with 2 separate HDR brachytherapy implants, each with one fraction of 13.5 Gray (Gy) with an interval of 7-14 days between treatments.
- interventionNames
- Radiation: HDR brachytherapy monotherapy
Primary outcomes (1)
- measure
- Disease-free survival
- timeFrame
- 5 years
- description
- Disease free survival as evaluated by absence of biochemical recurrence (Phoenix criteria) and absence of clinically/radiologically diagnosed local, regional or distant recurrence.
Secondary outcomes (1)
- measure
- Genito-urinary (GU) toxicity
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Biopsy proven Adenocarcinoma of the Prostate * Clinical stage T1c, T2a or T2b * PSA less than 20 ng/ml * Gleason Score 6 or 7 Exclusion Criteria: * Age less than 18 years * Clinical stage T2c, T3 ou T4 * Clinical Stage N1 * Clinical Stage M1 * Prostate Specific Antigen (PSA) more than 20 ng/ml * Gleason score 8 or higher * IPSS score 19 or higher with alpha-blockers * Past radiation therapy to the pelvis * History of Collagen Vascular Disease * History of Inflammatory Bowel Disease * Bilateral Hip Prosthesis
References
Publications (0)
Data not yet available
No reference posted for this study.