Clinical trial · Interventional
Improving Quality of Life After Prostate Brachytherapy: a Comparison of HDR and LDR Brachytherapy
IMPROVING QUALITY OF LIFE AFTER OPTIMAL RADIOTHERAPY FOR INTERMEDIATE AND HIGH RISK PROSTATE CANCER: A Randomized Comparison of HDR Versus LDR BRACHYTHERAPY BOOST
- 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)
Optimal non surgical treatment of prostate cancer requires dose escalation which is frequently provided by adding a brachytherapy "boost" to a short course of external beam radiotherapy. The hypothesis in this randomized study is that a High Dose Rate (HDR) brachytherapy boost leads to equivalent or better Prostate Specific Antigen (PSA) recurrence-free survival when compared to a Low Dose Rate (LDR) brachytherapy boost and that it is associated with a more favorable toxicity profile and improved 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HDR | Radiation | — | UNRESOLVED |
| LDR | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- LDR boost
- description
- After completion of 46 Gy of external beam radiotherapy subjects will undergo a permanent seed radioactive implant to the prostate using iodine-125 seeds to deliver a dose of 110 Gy
- interventionNames
- Radiation: LDR
- type
- ACTIVE_COMPARATOR
- label
- HDR boost
- description
- Subjects in this arm will undergo an HDR implant to deliver 15 Gy to the prostate prior to commencing the external beam component of their treatment.
- interventionNames
- Radiation: HDR
Primary outcomes (1)
- measure
- Compare Quality of Life between two arms as measured by EPIC questionnaire
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 45 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Upper tier intermediate risk with at least 2 of the following factors 1. Tumor-Nodes-Metastases Tumor stage T2B or greater 2. Gleason Score 7 3. PSA \> 10 4. \> 50% of the biopsies positive * OR High risk prostate cancer with one of the following factors 1. T3a 2. Gleason Score8-10 3. PSA \>20 * Positive prostate biopsy within 12 months (reviewed centrally) * International Prostate Symptom Score \< 16 * Prostate volume \< 60 cc * Negative staging CT and Bone scan within 3 months prior to registration * History and physical examination within 90 days prior to registration * European Cooperative Oncology Group performance status 0-1 prior to registration * Age \>45 * Patient suitable for procedure under anesthesia Exclusion Criteria: * Prior invasive malignancy (except non melanoma skin cancer) unless disease-free for at least 3 years prior to registration * Previous prostatectomy, cryotherapy or High Intensity Focussed Ultrasound for prostate cancer * Previous pelvic irradiation or prostate brachytherapy
References
Publications (7)
- BACKGROUNDBachand F, Martin AG, Beaulieu L, Harel F, Vigneault E. An eight-year experience of HDR brachytherapy boost for localized prostate cancer: biopsy and PSA outcome. Int J Radiat Oncol Biol Phys. 2009 Mar 1;73(3):679-84. doi: 10.1016/j.ijrobp.2008.05.003. Epub 2008 Oct 27. PMID 18963537
- 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
- BACKGROUNDMorton GC, Loblaw DA, Chung H, Tsang G, Sankreacha R, Deabreu A, Zhang L, Mamedov A, Cheung P, Batchelar D, Danjoux C, Szumacher E. Health-related quality of life after single-fraction high-dose-rate brachytherapy and hypofractionated external beam radiotherapy for prostate cancer. Int J Radiat Oncol Biol Phys. 2011 Aug 1;80(5):1299-305. doi: 10.1016/j.ijrobp.2010.04.046. Epub 2010 Aug 12. PMID 20708853
- BACKGROUNDPieters BR, de Back DZ, Koning CC, Zwinderman AH. Comparison of three radiotherapy modalities on biochemical control and overall survival for the treatment of prostate cancer: a systematic review. Radiother Oncol. 2009 Nov;93(2):168-73. doi: 10.1016/j.radonc.2009.08.033. Epub 2009 Sep 11. PMID 19748692
- BACKGROUNDDeutsch I, Zelefsky MJ, Zhang Z, Mo Q, Zaider M, Cohen G, Cahlon O, Yamada Y. Comparison of PSA relapse-free survival in patients treated with ultra-high-dose IMRT versus combination HDR brachytherapy and IMRT. Brachytherapy. 2010 Oct-Dec;9(4):313-8. doi: 10.1016/j.brachy.2010.02.196. Epub 2010 Aug 4. PMID 20685176
- BACKGROUNDStock RG, Stone NN, Cesaretti JA, Rosenstein BS. Biologically effective dose values for prostate brachytherapy: effects on PSA failure and posttreatment biopsy results. Int J Radiat Oncol Biol Phys. 2006 Feb 1;64(2):527-33. doi: 10.1016/j.ijrobp.2005.07.981. Epub 2005 Oct 19.