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Study of High-dose Rate (HDR) Monotherapy for Low and Intermediate Risk Prostate Cancer

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ClinicalTrials.gov Identifier: NCT02077335
Recruitment Status : Active, not recruiting
First Posted : March 4, 2014
Last Update Posted : January 26, 2018
Sponsor:
Information provided by (Responsible Party):
Marc Gaudet, CSSS de Gatineau

Brief Summary:
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 or disease Intervention/treatment Phase
Prostate Cancer Radiation: HDR brachytherapy monotherapy Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
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
Study Start Date : April 2014
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
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.





Primary Outcome Measures :
  1. 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 :
  1. 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:
  1. Overall survival [ Time Frame: 5 years ]
  2. Gastro-Intestinal (GI) Toxicity [ Time Frame: 6 weeks, 2 years and 5 years post treatment ]
    Toxicity according to Expanded Prostate Index Composite (EPIC) questionnaires.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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

Responsible Party: Marc Gaudet, Radiation Oncologist, CSSS de Gatineau
ClinicalTrials.gov Identifier: NCT02077335     History of Changes
Other Study ID Numbers: CSSSG-001
First Posted: March 4, 2014    Key Record Dates
Last Update Posted: January 26, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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