Clinical trial · Interventional
Internal Radiation Therapy in Treating Patients With Low-Risk Prostate Cancer
A Phase II Study of Targeted Brachytherapy for Low Risk Prostate Cancer Patients
NCT01859689CI-TRIAL-00046190withdrawnPhase 2ClinicalTrials.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): no participants enrolled
Summary
Brief summary (as posted)
This phase II trial studies how well internal radiation therapy works in treating patients with low-risk prostate cancer. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma of the Prostate | Prostate Adenocarcinoma | ALIAS | 0.90 |
| Recurrent Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIA Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIB Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage I Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| brachytherapy | Radiation | — | UNRESOLVED |
| image-guided radiation therapy | Radiation | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (image-guided HDR brachytherapy)
- description
- Patients undergo 3 fractions of image-guided HDR brachytherapy over 2 days.
- interventionNames
- Radiation: brachytherapy
- Radiation: image-guided radiation therapy
- Other: laboratory biomarker analysis
Primary outcomes (1)
- measure
- Biochemical PSA control using the Phoenix definition of PSA nadir + 2
- timeFrame
- 5 years
Secondary outcomes (5)
- measure
- Grade 3-5 acute toxicity genitourinary (GU) and gastrointestinal (GI) toxicity, graded based on NCI CTCAE v4.0
- timeFrame
- 3 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed primary non-metastatic adenocarcinoma of the prostate * Unilateral prostate cancer as determined by prostate biopsy * Less than or equal to 3 positive biopsy cores * No biopsy core \>= 50% positive for cancer * Karnofsky performance status (KPS) \>= 70 * At least a 12 core prostate biopsy; if this was not performed then it will be repeated here at University of California at Los Angeles (UCLA) * Artemis guided biopsy of any suspicious target lesions as identified on multiparametric (mp)-magnetic resonance imaging (MRI) * Clinical stage T1c or T2a * PSA \< 10 ng/ml * Gleason score 3+3=6 Exclusion Criteria: * Patients who have previously received radiation therapy to the pelvis * Refusal to sign the informed consent * Patients who are participating in a concurrent treatment protocol
References
Publications (0)
Data not yet available
No reference posted for this study.