Clinical trial · Interventional
LDR vs. HDR Brachytherapy for Prostate Cancer
A Phase III Randomized Study of Low Dose Rate Compared to High Dose Rate Prostate Brachytherapy for Favorable Risk and Low Tier Intermediate Risk Prostate Cancer
NCT03426748CI-TRIAL-00101907LDR/HDRmonoactive not recruitingN/AClinicalTrials.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)
H17-02904 is a randomized comparison of low dose rate vs. high dose rate prostate brachytherapy for favorable and intermediate risk prostate cancer suitable for brachytherapy as monotherapy. This is a continuation with expanded accrual of the randomized Pilot study H15-02103
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 |
|---|---|---|---|
| High dose rate prostate brachytherapy | Radiation | — | UNRESOLVED |
| Low dose rate prostate brachytherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Low dose rate brachytherapy
- description
- Device: Radiation. Low dose rate prostate brachytherapy is delivered under anesthesia in a single 1.5-2 hour procedure as an out-patient. The men return 4 weeks later for detailed imaging to assess implant quality.
- interventionNames
- Radiation: Low dose rate prostate brachytherapy
- type
- EXPERIMENTAL
- label
- High dose rate brachytherapy
- description
- Device: Radiation. High dose rate prostate brachytherapy is delivered in 2 procedures, 2 weeks apart, also under anesthesia, but no follow-up imaging visit is required. HDR brachytherapy is also accomplished as an out-patient.
- interventionNames
- Radiation: High dose rate prostate brachytherapy
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: Favorable risk and low-tier intermediate-risk prostate cancer with estimated life expectancy of at least 10 years. * Clinical stage T1c-T2b, PSA \< 20, Gleason \< 8 * ECOG 0-1 * Low tier intermediate-risk prostate cancer is defined by a single NCCN intermediate risk factor * Extensive favorable-risk disease is defined as: * clinical stage T1c-T2a * PSA \< 10 * Gleason 6 * ≥ 50% of biopsy cores containing cancer * PSA density \> 0.2 ng/cc * Selected intermediate risk patients not defined above * \- T1c/T2a * \- PSA \< 10 * -Gleason 4+3 * PSA \> 10 and Gleason 3+4 * PSA 10-15 ng/ml and Gleason 4+3 * -\< 33% of cores involved * -Max tumor length in any core 10 mm * No androgen deprivation therapy (ADT) * Prostate volume by TRUS ≤ 60 cc. * Not eligible for, or accepting of, active surveillance according to NCCN guidelines. * Signed study specific informed consent. Exclusion Criteria: * Prior radical surgery for carcinoma of the prostate, * Prior pelvic radiation * Prior chemotherapy for prostate cancer, * Prior TURP or cryosurgery of the prostate * Claustrophobic or unable to undergo MRI
References
Publications (3)
- BACKGROUNDCrook J, Ots A, Gaztanaga M, Schmid M, Araujo C, Hilts M, Batchelar D, Parker B, Bachand F, Milette MP. Ultrasound-planned high-dose-rate prostate brachytherapy: dose painting to the dominant intraprostatic lesion. Brachytherapy. 2014 Sep-Oct;13(5):433-41. doi: 10.1016/j.brachy.2014.05.006. Epub 2014 Jun 20. PMID 24958556
- BACKGROUNDBatchelar D, Gaztanaga M, Schmid M, Araujo C, Bachand F, Crook J. Validation study of ultrasound-based high-dose-rate prostate brachytherapy planning compared with CT-based planning. Brachytherapy. 2014 Jan-Feb;13(1):75-9. doi: 10.1016/j.brachy.2013.08.004. Epub 2013 Sep 27. PMID 24080299
- BACKGROUNDSchmid M, Crook JM, Batchelar D, Araujo C, Petrik D, Kim D, Halperin R. A phantom study to assess accuracy of needle identification in real-time planning of ultrasound-guided high-dose-rate prostate implants. Brachytherapy. 2013 Jan-Feb;12(1):56-64. doi: 10.1016/j.brachy.2012.03.002. Epub 2012 Apr 17. PMID 22513104