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Trial record 1 of 1 for:    CSSSG
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Study of High-dose Rate (HDR) Monotherapy for Low and Intermediate Risk Prostate Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02077335
First Posted: March 4, 2014
Last Update Posted: December 21, 2016
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.
Information provided by (Responsible Party):
Marc Gaudet, CSSS de Gatineau
  Purpose
The purpose of this study is to determine the clinical efficacy and toxicity of High-dose rate (HDR) brachytherapy as monotherapy for the treatment of low risk and intermediate risk prostate cancer.

Condition Intervention Phase
Prostate Cancer Radiation: HDR brachytherapy monotherapy Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of High-dose Rate (HDR) Monotherapy for the Treatment of Low and Intermediate Risk Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Marc Gaudet, CSSS de Gatineau:

Primary Outcome Measures:
  • Disease-free survival [ Time Frame: 5 years ]
    Disease free survival as evaluated by absence of biochemical recurrence (Phoenix criteria) and absence of clinically/radiologically diagnosed local, regional or distant recurrence.


Secondary Outcome Measures:
  • Genito-urinary (GU) toxicity [ Time Frame: 6 weeks, 2 years and 5 years post treatment ]
    Toxicity according to International prostate symptom score (IPSS) and Expanded Prostate Index Composite (EPIC) questionnaires.


Other Outcome Measures:
  • Overall survival [ Time Frame: 5 years ]
  • Gastro-Intestinal (GI) Toxicity [ Time Frame: 6 weeks, 2 years and 5 years post treatment ]
    Toxicity according to Expanded Prostate Index Composite (EPIC) questionnaires.


Estimated Enrollment: 50
Study Start Date: April 2014
Estimated Study Completion Date: September 2022
Estimated Primary Completion Date: September 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HDR brachytherapy monotherapy
Radiation therapy: Treatment with 2 separate HDR brachytherapy implants, each with one fraction of 13.5 Gray (Gy) with an interval of 7-14 days between treatments.
Radiation: HDR brachytherapy monotherapy

Radiation therapy in the study consists of treatment with 2 separate interstitial HDR brachytherapy procedures with temporary interstitial catheters, each with one fraction of 13.5 Gray (Gy). Both procedures will be done in an identical manner. The 2 procedures will be separated by an interval of 7-14 days Treatments will be done with interstitial catheters inserted transperineally with transrectal ultrasound guidance under sterile conditions. Optimization of treatment plan will be done with Brachyvision software (Varian, Palo Alto CA) based on CT-scan imaging done post-implant. Optimization parameters will be the following:

Prostate :

  • V100 > 95%
  • V150 30-35%
  • V200 < 15%
  • D90 > 90% (12,15Gy)

Bladder

• V75 < 1cc

Rectum

• V75 < 1cc

Urethra

V125 = 0cc D10 < 120%

Treatments will be carried out with an Iridium-192 afterloader. Source and all catheters will be removed from the patient at the end of the procedure.


  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Biopsy proven Adenocarcinoma of the Prostate
  • Clinical stage T1c, T2a or T2b
  • PSA less than 20 ng/ml
  • Gleason Score 6 or 7

Exclusion Criteria:

  • Age less than 18 years
  • Clinical stage T2c, T3 ou T4
  • Clinical Stage N1
  • Clinical Stage M1
  • Prostate Specific Antigen (PSA) more than 20 ng/ml
  • Gleason score 8 or higher
  • IPSS score 19 or higher with alpha-blockers
  • Past radiation therapy to the pelvis
  • History of Collagen Vascular Disease
  • History of Inflammatory Bowel Disease
  • Bilateral Hip Prosthesis
  Contacts and Locations
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): NCT02077335


Locations
Canada, Quebec
CSSS de Gatineau
Gatineau, Quebec, Canada, J8P 7H2
Sponsors and Collaborators
CSSS de Gatineau
  More Information

Responsible Party: Marc Gaudet, Radiation Oncologist, CSSS de Gatineau
ClinicalTrials.gov Identifier: NCT02077335     History of Changes
Other Study ID Numbers: CSSSG-001
First Submitted: February 23, 2014
First Posted: March 4, 2014
Last Update Posted: December 21, 2016
Last Verified: December 2016

Keywords provided by Marc Gaudet, CSSS de Gatineau:
Brachytherapy
Monotherapy
HDR

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases


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