Clinical trial · Interventional
Assessing the Potential for Reduced Toxicity Using Focal Brachytherapy in Early Stage, Low Volume Prostate Cancer
Phase II Study Assessing the Potential for Reduced Toxicity Using Focal Brachytherapy Early Stage, Low Volume in Prostate Cancer
NCT01354951CI-TRIAL-00035368terminatedPhase 2Results postedClinicalTrials.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): Lack of accrual
Summary
Brief summary (as posted)
The purpose of this study is to see what side effects a type of radiation treatment called focal brachytherapy has in treating early stage prostate cancer. The study is also looking at how useful focal brachytherapy will be in treating prostate cancer. Additionally, the investigators would like to see how this type of treatment impacts quality of life.
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 |
|---|---|---|---|
| Prostate Biopsy, Focal Brachytherapy , Assessment of QOL | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Prostate Biopsy, Focal Brachytherapy , Assessment of QOL
- description
- This is a non-randomized, Phase II study examining the tolerance profile (primary endpoint) as well as the secondary endpoints of QOL changes, efficacy and the correlation of post-treatment MRI findings with post-treatment biopsy outcomes in men with early stage low volume prostate cancer treated with focal brachytherapy.
- interventionNames
- Other: Prostate Biopsy, Focal Brachytherapy , Assessment of QOL
Primary outcomes (1)
- measure
- To Assess the Late Toxicity Outcomes
- timeFrame
- 6 months to 2 years
- description
- focal brachytherapy in patients with low risk prostate cancer This study will utilize the toxicity grading scale Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Secondary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Men ≥ 21 years of age with a life expectancy estimated to be \> 10-years. * Diagnosis of adenocarcinoma of the prostate confirmed by MSKCC or participating site pathology review. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Prostate cancer clinical stage T1c-T2a * PSA \< 10ng/mL (this will be the PSA level prompting the prostate biopsy) * MRI evidence of one-sided disease performed within 3 months of registration * Prostate size \<60 cc at time of treatment- if the prostate is larger, hormonal therapy is allowed to achieve the required size Screening biopsy parameters: * Minimum of 10 biopsy cores * Gleason grade 7 in two cores or less, with no primary Gleason grade 4 or 5 in any cores * Unilateral cancer (only right-sided or left-sided, not bilateral) * No more than 50 % cancer in any one biopsy core * No more than 25 % of cores containing cancer * Repeat transrectal or transperineal prostate biopsy that must meet the following parameters: * Minimum of 12 biopsy cores * Unilateral cancer (only right-sided or left-sided, not bilateral) * Gleason grade 7 in two cores or less, with no primary Gleason grade 4 or 5 in any cores * No more than 50 % cancer in any one biopsy core * No more than 25 % of cores containing cancer Subject Exclusion Criteria: * Medically unfit for anesthesia * Evidence or suspicion of extracapsular extension on MRI * IPSS score \> 18 * Unable to receive MRI * Prior radiotherapy for the current disease
References
Publications (0)
Data not yet available
No reference posted for this study.