Prostate Cancer Clinical Trial
— BRP2Official title:
HDR Brachytherapy Used as Monotherapy for Low and Intermediate Risk Prostate Cancer: a Phase II Randomized Trial
Verified date | March 2022 |
Source | CR-CSSS Champlain-Charles-Le Moyne |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 199 |
Est. completion date | February 22, 2022 |
Est. primary completion date | June 22, 2019 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 85 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Canada | Hôpital Charles LeMoyne | Greenfield Park | Quebec |
Lead Sponsor | Collaborator |
---|---|
CR-CSSS Champlain-Charles-Le Moyne |
Canada,
Bachand 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. — View Citation
Barkati M, Williams SG, Foroudi F, Tai KH, Chander S, van Dyk S, See A, Duchesne GM. High-dose-rate brachytherapy as a monotherapy for favorable-risk prostate cancer: a Phase II trial. Int J Radiat Oncol Biol Phys. 2012 Apr 1;82(5):1889-96. doi: 10.1016/j.ijrobp.2010.09.006. Epub 2011 May 6. — View Citation
Cury FL, Duclos M, Aprikian A, Patrocinio H, Kassouf W, Shenouda G, Faria S, David M, Souhami L. Single-fraction high-dose-rate brachytherapy and hypofractionated external beam radiation therapy in the treatment of intermediate-risk prostate cancer - long term results. Int J Radiat Oncol Biol Phys. 2012 Mar 15;82(4):1417-23. doi: 10.1016/j.ijrobp.2011.05.025. Epub 2011 Jul 23. — View Citation
Davis 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. — View Citation
Demanes DJ, Martinez AA, Ghilezan M, Hill DR, Schour L, Brandt D, Gustafson G. High-dose-rate monotherapy: safe and effective brachytherapy for patients with localized prostate cancer. Int J Radiat Oncol Biol Phys. 2011 Dec 1;81(5):1286-92. doi: 10.1016/j.ijrobp.2010.10.015. Epub 2011 Feb 9. — View Citation
Deutsch 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. — View Citation
Ghilezan M, Martinez A, Gustason G, Krauss D, Antonucci JV, Chen P, Fontanesi J, Wallace M, Ye H, Casey A, Sebastian E, Kim L, Limbacher A. High-dose-rate brachytherapy as monotherapy delivered in two fractions within one day for favorable/intermediate-risk prostate cancer: preliminary toxicity data. Int J Radiat Oncol Biol Phys. 2012 Jul 1;83(3):927-32. doi: 10.1016/j.ijrobp.2011.05.001. Epub 2011 Dec 23. — View Citation
Herbert 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. — View Citation
Holly R, Morton GC, Sankreacha R, Law N, Cisecki T, Loblaw DA, Chung HT. Use of cone-beam imaging to correct for catheter displacement in high dose-rate prostate brachytherapy. Brachytherapy. 2011 Jul-Aug;10(4):299-305. doi: 10.1016/j.brachy.2010.11.007. Epub 2010 Dec 28. — View Citation
Hoskin P, Rojas A, Lowe G, Bryant L, Ostler P, Hughes R, Milner J, Cladd H. High-dose-rate brachytherapy alone for localized prostate cancer in patients at moderate or high risk of biochemical recurrence. Int J Radiat Oncol Biol Phys. 2012 Mar 15;82(4):1376-84. doi: 10.1016/j.ijrobp.2011.04.031. Epub 2011 Jun 15. — View Citation
Hoskin P, Rojas A, Ostler P, Hughes R, Alonzi R, Lowe G, Bryant L. High-dose-rate brachytherapy alone given as two or one fraction to patients for locally advanced prostate cancer: acute toxicity. Radiother Oncol. 2014 Feb;110(2):268-71. doi: 10.1016/j.radonc.2013.09.025. Epub 2013 Nov 11. — View Citation
Hoskin PJ, Rojas AM, Bownes PJ, Lowe GJ, Ostler PJ, Bryant L. Randomised trial of external beam radiotherapy alone or combined with high-dose-rate brachytherapy boost for localised prostate cancer. Radiother Oncol. 2012 May;103(2):217-22. doi: 10.1016/j.radonc.2012.01.007. Epub 2012 Feb 16. — View Citation
Jolicoeur, M., Derashodian, T., Last, J., Wakil, G., & Mondat, M. (2017). Multimodality Image Registrations for Combined MRI/CT HDR Prostate Brachytherapy: The Concept of the Iurethra. International Journal of Radiation Oncology*Biology*Physics, 99(2), E243-E244. https://doi.org/10.1016/J.IJROBP.2017.06.1185
Kolkman-Deurloo IK, Roos MA, Aluwini S. HDR monotherapy for prostate cancer: a simulation study to determine the effect of catheter displacement on target coverage and normal tissue irradiation. Radiother Oncol. 2011 Feb;98(2):192-7. doi: 10.1016/j.radonc.2010.12.009. Epub 2011 Feb 3. — View Citation
Martinez AA, Demanes J, Vargas C, Schour L, Ghilezan M, Gustafson GS. High-dose-rate prostate brachytherapy: an excellent accelerated-hypofractionated treatment for favorable prostate cancer. Am J Clin Oncol. 2010 Oct;33(5):481-8. doi: 10.1097/COC.0b013e3181b9cd2f. — View Citation
Martinez AA, Gonzalez J, Ye H, Ghilezan M, Shetty S, Kernen K, Gustafson G, Krauss D, Vicini F, Kestin L. Dose escalation improves cancer-related events at 10 years for intermediate- and high-risk prostate cancer patients treated with hypofractionated high-dose-rate boost and external beam radiotherapy. Int J Radiat Oncol Biol Phys. 2011 Feb 1;79(2):363-70. doi: 10.1016/j.ijrobp.2009.10.035. — View Citation
Morton G, Loblaw A, Cheung P, Szumacher E, Chahal M, Danjoux C, Chung HT, Deabreu A, Mamedov A, Zhang L, Sankreacha R, Vigneault E, Springer C. Is single fraction 15 Gy the preferred high dose-rate brachytherapy boost dose for prostate cancer? Radiother Oncol. 2011 Sep;100(3):463-7. doi: 10.1016/j.radonc.2011.08.022. Epub 2011 Sep 14. — View Citation
Morton 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. — View Citation
Morton GC, Loblaw DA, Sankreacha R, Deabreu A, Zhang L, Mamedov A, Cheung P, Keller B, Danjoux C, Szumacher E, Thomas G. Single-fraction high-dose-rate brachytherapy and hypofractionated external beam radiotherapy for men with intermediate-risk prostate cancer: analysis of short- and medium-term toxicity and quality of life. Int J Radiat Oncol Biol Phys. 2010 Jul 1;77(3):811-7. doi: 10.1016/j.ijrobp.2009.05.054. Epub 2009 Oct 14. — View Citation
Morton GC. The emerging role of high-dose-rate brachytherapy for prostate cancer. Clin Oncol (R Coll Radiol). 2005 Jun;17(4):219-27. Review. — View Citation
Prada PJ, Jimenez I, González-Suárez H, Fernández J, Cuervo-Arango C, Mendez L. High-dose-rate interstitial brachytherapy as monotherapy in one fraction and transperineal hyaluronic acid injection into the perirectal fat for the treatment of favorable stage prostate cancer: treatment description and preliminary results. Brachytherapy. 2012 Mar-Apr;11(2):105-10. doi: 10.1016/j.brachy.2011.05.003. Epub 2011 Sep 14. — View Citation
Rogers CL, Alder SC, Rogers RL, Hopkins SA, Platt ML, Childs LC, Crouch RH, Hansen RS, Hayes JK. High dose brachytherapy as monotherapy for intermediate risk prostate cancer. J Urol. 2012 Jan;187(1):109-16. doi: 10.1016/j.juro.2011.09.050. Epub 2011 Nov 16. — View Citation
Taira AV, Merrick GS, Galbreath RW, Wallner KE, Butler WM. Natural history of clinically staged low- and intermediate-risk prostate cancer treated with monotherapeutic permanent interstitial brachytherapy. Int J Radiat Oncol Biol Phys. 2010 Feb 1;76(2):349-54. doi: 10.1016/j.ijrobp.2009.02.021. Epub 2009 May 19. — View Citation
Wang 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. — View Citation
Yamada 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. — View Citation
Yoshioka Y, Konishi K, Oh RJ, Sumida I, Yamazaki H, Nakamura S, Nishimura K, Nonomura N, Okuyama A, Inoue T. High-dose-rate brachytherapy without external beam irradiation for locally advanced prostate cancer. Radiother Oncol. 2006 Jul;80(1):62-8. Epub 2006 Jul 25. — View Citation
* Note: There are 26 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Acute (early) genitourinary and gastrointestinal toxicity | Acute genitourinary and gastrointestinal toxicities of HDR Brachytherapy will be graded using the Radiation Therapy Oncology Group (RTOG) Score at each follow up time point. | 10 years | |
Secondary | Overall survival | The difference in median overall survival will be compared between the two arms. Overall survival (OS) measured in months from baseline to death from any cause. |
10 years | |
Secondary | Local - Progression free survival (PFS) | The difference in median PFS will be compared between the two arms. Progression free survival (PFS) measured in months from baseline to local disease relapse. | 10 years | |
Secondary | Distant - Progression free survival (PFS) | The difference in median PFS will be compared between the two arms. Progression free survival (PFS) measured in months from baseline to distant disease relapse. | 10 years | |
Secondary | Evolution of the International Prostate Symptom Score (IPSS) and time to return to baseline | IPSS scores will be measured at baseline, 1 week, 3 weeks, 6 weeks, 6 months, 12 months, 24 months and 36 months. | 3 years | |
Secondary | Late genitourinary and gastrointestinal toxicities changes | Late Late genitourinary and gastrointestinal toxicities measured measured by CTCAE v4 and RTOG score | 10 years | |
Secondary | Biochemical failure | PSA measure changes will be recorded every 3 months for the first 2 years, every 6 months to 5 years and then annually to 10 years. | 10 years | |
Secondary | Erectile dysfunction rates - IIEF5 score | IIEF5 scores will be measured at baseline, 1 week, 3 weeks, 6 weeks, 6 months, 12 months, 24 months and 36 months. | 3 years | |
Secondary | Associations between dosimetric parameters and toxicity | Patients with symptomatic prostatitis will be identified | 3 years | |
Secondary | Associations between iUrethra and toxicity | iUrethra is represented by urethra MRI imaging and draw upon the length of the previous targeted volume (1cm inferior and superior margins). iUrethra differs from the urethra measure, since it is not draw upon the urinary catheter. |
3 years | |
Secondary | Changes in the quality of life of patients - EORTC QLQ-C30 | Scores will be evaluated at baseline, 1, 3, 6, 12, 24, 36 and 60 months | 5 years |
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