HDR Brachytherapy as Monotherapy for Low and Intermediate Risk Prostate Cancer

NCT03424694 | Completed

• 1 other identifier: AA-HCLM-14-034
• Study Type: interventional
• Target: 199
• Locations: 1 country
• Sites: 1

Brief Summary

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

Prostate Cancer

Keywords

Brachytherapy; Monotherapy; HDR Brachytherapy; Toxicity; Quality of Life; Progression Free Survival

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Overall survival

  10 years

• Local - Progression free survival (PFS)

  10 years

• Distant - Progression free survival (PFS)

  10 years

• Evolution of the International Prostate Symptom Score (IPSS) and time to return to baseline

  3 years

• Late genitourinary and gastrointestinal toxicities changes

  10 years

Study Arms (2)

2 fractions of 14.5 Gy HDR Brachytherapy

EXPERIMENTAL

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.

Radiation: HDR brachytherapy as monotherapy

1 fraction of 19.5 Gy HDR brachytherapy

EXPERIMENTAL

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.

Radiation: HDR brachytherapy as monotherapy

Interventions

HDR brachytherapy as monotherapy RADIATION

1 fraction of 19.5 Gy HDR brachytherapy; 2 fractions of 14.5 Gy HDR Brachytherapy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• CR-CSSS Champlain-Charles-Le Moyne: lead

Study Sites (1)

Hôpital Charles LeMoyne

Greenfield Park, Quebec, J4V 2H1, Canada

Location

Related Publications (26)

• 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. doi: 10.1016/j.brachy.2006.08.006.

  PMID: 17118319 BACKGROUND

• 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.

  PMID: 22265434 BACKGROUND

• 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.

  PMID: 22326573 BACKGROUND

• Morton 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 BACKGROUND

• 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.

  PMID: 22265435 BACKGROUND

• 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.

  PMID: 18963537 BACKGROUND

• 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.

  PMID: 21195875 BACKGROUND

• 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.

  PMID: 20685176 BACKGROUND

• 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.

  PMID: 22341794 BACKGROUND

• 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.

  PMID: 19836166 BACKGROUND

• 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.

  PMID: 21784585 BACKGROUND

• 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.

  PMID: 21924511 BACKGROUND

• 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.

  PMID: 19467793 BACKGROUND

• 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.

  PMID: 21550182 BACKGROUND

• 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.

  PMID: 21310546 BACKGROUND

• 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.

  PMID: 22088340 BACKGROUND

• 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.

  PMID: 19952715 BACKGROUND

• 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.

  PMID: 21190903 BACKGROUND

• 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.

  PMID: 21295878 BACKGROUND

• 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.

  PMID: 22197086 BACKGROUND

• 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.

  PMID: 21680108 BACKGROUND

• Prada PJ, Jimenez I, Gonzalez-Suarez H, Fernandez 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.

  PMID: 21917528 BACKGROUND

• 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.

  PMID: 20708853 BACKGROUND

• 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. doi: 10.1016/j.radonc.2006.06.011. Epub 2006 Jul 25.

  PMID: 16870289 BACKGROUND

• 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.

  PMID: 24231242 BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Marjory Jolicoeur, MD

  CSSS Champlain-Charles-Le Moyne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Radiation: HDR brachytherapy monotherapy (1 vs 2 fractions on single implant) Brachytherapy in this study consists of treatment with a single interstitial HDR brachytherapy procedures with temporary interstitial catheters. The number of temporary interstitial catheters will be based on the size and shape of the prostate (at least 16 catheters will be implanted). In one arm patient will received a single fraction of 19.5 Gray (Gy), in the other arm patient will received 29 Gy/ 2 fractions of 14.5 Gy separated by 6 hours on a single implant. Implant will be done with transperineal insertion of interstitial catheters under sterile conditions guided by transrectal ultrasounds. Optimization of treatment plan will be done with Oncentra (Elekta) based on MRI imaging done post-implant.

Study Record Dates

• First Submitted: January 29, 2018
• First Posted: February 7, 2018
• Study Start: June 22, 2015
• Primary Completion: June 22, 2019
• Study Completion: February 22, 2022
• Last Updated: March 17, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)