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HDR Brachytherapy as Monotherapy for Low and Intermediate Risk Prostate Cancer (BRP2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03424694
Recruitment Status : Active, not recruiting
First Posted : February 7, 2018
Last Update Posted : July 26, 2019
Sponsor:
Information provided by (Responsible Party):
Marjory Jolicoeur, CR-CSSS Champlain-Charles-Le Moyne

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

Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: HDR brachytherapy as monotherapy Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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.

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: HDR Brachytherapy Used as Monotherapy for Low and Intermediate Risk Prostate Cancer: a Phase II Randomized Trial
Actual Study Start Date : June 22, 2015
Actual Primary Completion Date : June 22, 2019
Estimated Study Completion Date : June 22, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: 2 fractions of 14.5 Gy HDR Brachytherapy

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
Experimental: 1 fraction of 19.5 Gy HDR brachytherapy

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



Primary Outcome Measures :
  1. Acute and late genitourinary and gastrointestinal toxicity [ Time Frame: 10 years ]
    Acute and long-term genitourinary and gastrointestinal toxicities of HDR Brachytherapy will be graded using the Radiation Therapy Oncology Group (RTOG) Score at each follow up time point.


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 10 years ]

    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.


  2. Local - Progression free survival (PFS) [ Time Frame: 10 years ]
    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.

  3. Distant - Progression free survival (PFS) [ Time Frame: 10 years ]
    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.

  4. Evolution of the International Prostate Symptom Score (IPSS) and time to return to baseline [ Time Frame: 3 years ]
    IPSS scores will be measured at baseline, 1 week, 3 weeks, 6 weeks, 6 months, 12 months, 24 months and 36 months.

  5. Gastrointestinal toxicities changes measured by RTOG score [ Time Frame: 10 years ]
    Gastrointestinal toxicities changes measured by Radiation Therapy Oncology Group (RTOG) score.

  6. Biochemical failure [ Time Frame: 10 years ]
    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.

  7. Erectile dysfunction rates - IIEF5 score [ Time Frame: 3 years ]
    IIEF5 scores will be measured at baseline, 1 week, 3 weeks, 6 weeks, 6 months, 12 months, 24 months and 36 months.

  8. Associations between dosimetric parameters and toxicity [ Time Frame: 3 years ]
    Patients with symptomatic prostatitis will be identified

  9. Associations between iUrethra and toxicity [ Time Frame: 3 years ]

    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.


  10. Changes in the quality of life of patients - EORTC QLQ-C30 [ Time Frame: 5 years ]
    Scores will be evaluated at baseline, 1, 3, 6, 12, 24, 36 and 60 months



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03424694


Locations
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Canada, Quebec
Hôpital Charles LeMoyne
Greenfield Park, Quebec, Canada, J4V 2H1
Sponsors and Collaborators
CR-CSSS Champlain-Charles-Le Moyne
Investigators
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Principal Investigator: Marjory Jolicoeur, MD CSSS Champlain-Charles-Le Moyne

Publications:
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

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Responsible Party: Marjory Jolicoeur, MD, CR-CSSS Champlain-Charles-Le Moyne
ClinicalTrials.gov Identifier: NCT03424694     History of Changes
Other Study ID Numbers: AA-HCLM-14-034
First Posted: February 7, 2018    Key Record Dates
Last Update Posted: July 26, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marjory Jolicoeur, CR-CSSS Champlain-Charles-Le Moyne:
Brachytherapy
Monotherapy
HDR Brachytherapy
Toxicity
Quality of Life
Progression Free Survival
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases