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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02077335
• Other study ID #: CSSSG-001
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: April 2014
• Est. completion date: March 2026

Study information

• Verified date: February 2024
• Source: CSSS de Gatineau
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: March 2026
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Canada	CSSS de Gatineau	Gatineau	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
CSSS de Gatineau

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Overall survival		5 years
Other	Gastro-Intestinal (GI) Toxicity	Toxicity according to Expanded Prostate Index Composite (EPIC) questionnaires.	6 weeks, 2 years and 5 years post treatment
Primary	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	Genito-urinary (GU) toxicity	Toxicity according to International prostate symptom score (IPSS) and Expanded Prostate Index Composite (EPIC) questionnaires.	6 weeks, 2 years and 5 years post treatment