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

NCT02077335 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: CSSSG-001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Brachytherapy; Monotherapy; HDR

Outcome Measures

Primary Outcomes (1)

• Disease-free survival

  Disease free survival as evaluated by absence of biochemical recurrence (Phoenix criteria) and absence of clinically/radiologically diagnosed local, regional or distant recurrence.

  5 years

Secondary Outcomes (1)

• Genito-urinary (GU) toxicity

  6 weeks, 2 years and 5 years post treatment

Other Outcomes (2)

• Overall survival

  5 years

• Gastro-Intestinal (GI) Toxicity

  6 weeks, 2 years and 5 years post treatment

Study Arms (1)

HDR brachytherapy monotherapy

EXPERIMENTAL

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

Interventions

HDR brachytherapy monotherapy RADIATION

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.

HDR brachytherapy monotherapy

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• CSSS de Gatineau: lead

Study Sites (1)

CSSS de Gatineau

Gatineau, Quebec, J8P 7H2, Canada

Location

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 Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiation Oncologist

Study Record Dates

• First Submitted: February 23, 2014
• First Posted: March 4, 2014
• Study Start: April 1, 2014
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: February 21, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)