Clinical trial · Interventional
HDR Brachytherapy as Monotherapy for Low and Intermediate Risk Prostate Cancer
HDR Brachytherapy Used as Monotherapy for Low and Intermediate Risk Prostate Cancer: a Phase II Randomized Trial
NCT03424694CI-TRIAL-00057193BRP2completedN/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)
The purpose of this study is to evaluate High-dose rate (HDR) brachytherapy (1 vs 2 fractions on single implant) 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 as monotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 2 fractions of 14.5 Gy HDR Brachytherapy
- description
- High Dose Rate (HDR) Brachytherapy as monotherapy at a dose of 29 Gy is delivered in 2 fractions of 14.5 Gy, minimum 6 hours a part, delivered on a single implant procedure with 2 MRI assisted plannings and dosimetries. HDR brachytherapy implant is done under anesthesia with ultrasound guidance as an out-patient procedure.
- interventionNames
- Radiation: HDR brachytherapy as monotherapy
- type
- EXPERIMENTAL
- label
- 1 fraction of 19.5 Gy HDR brachytherapy
- description
- HDR Brachytherapy as monotherapy at a dose 19.5 Gy is delivered in 1 fraction. Treatment is done on a single ultrasound guided implant, post implant MRI assisted planning and dosimetry. HDR brachytherapy implant is done under anesthesia with ultrasound guidance as an out-patient procedure.
- interventionNames
- Radiation: HDR brachytherapy as monotherapy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven prostate adenocarcinoma * Clinical Stage T1c - T2c * Gleason Score between 6 and 7 * PSA \< 15 ng / ml * Prostate volume \< 70 cc as determined by ultrasound or IRM * Signed informer consent * Clinical conditions for complete diagnosis checkup and treatment procedure * Should be able to complete IIEFS,IPSS and QLQ-C30 questionnaires * Bone and pelvic scan negative for metastasis Exclusion Criteria: * Prior pelvis radiation * Prior Transurethral resection of the prostate (TURP) (less than 6 months) * International Prostate Symptom Score: IPSS \> 16 * Contraindication to radiotherapy * No prior use of Androgen deprivation therapy (ADT) * Observation: 5 alpha-reductase (5AR) inhibitors is authorized.
References
Publications (26)
- BACKGROUNDWang Y, Sankreacha R, Al-Hebshi A, Loblaw A, Morton G. Comparative study of dosimetry between high-dose-rate and permanent prostate implant brachytherapies in patients with prostate adenocarcinoma. Brachytherapy. 2006 Oct-Dec;5(4):251-5. doi: 10.1016/j.brachy.2006.08.006. PMID 17118319
- BACKGROUNDDavis BJ, Horwitz EM, Lee WR, Crook JM, Stock RG, Merrick GS, Butler WM, Grimm PD, Stone NN, Potters L, Zietman AL, Zelefsky MJ; American Brachytherapy Society. American Brachytherapy Society consensus guidelines for transrectal ultrasound-guided permanent prostate brachytherapy. Brachytherapy. 2012 Jan-Feb;11(1):6-19. doi: 10.1016/j.brachy.2011.07.005. PMID 22265434
- BACKGROUNDHerbert C, Morris WJ, Keyes M, Hamm J, Lapointe V, McKenzie M, Pickles T, Spadinger I. Outcomes following iodine-125 brachytherapy in patients with Gleason 7, intermediate risk prostate cancer: a population-based cohort study. Radiother Oncol. 2012 May;103(2):228-32. doi: 10.1016/j.radonc.2012.01.006. Epub 2012 Feb 10. PMID 22326573
- BACKGROUNDMorton GC. The emerging role of high-dose-rate brachytherapy for prostate cancer. Clin Oncol (R Coll Radiol). 2005 Jun;17(4):219-27. doi: 10.1016/j.clon.2004.12.005. PMID 15997914
- BACKGROUNDYamada Y, Rogers L, Demanes DJ, Morton G, Prestidge BR, Pouliot J, Cohen GN, Zaider M, Ghilezan M, Hsu IC; American Brachytherapy Society. American Brachytherapy Society consensus guidelines for high-dose-rate prostate brachytherapy. Brachytherapy. 2012 Jan-Feb;11(1):20-32. doi: 10.1016/j.brachy.2011.09.008. PMID 22265435
- 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