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

CSSS de Gatineau

Status and phase: Active, not recruiting; Phase 2

Conditions: Prostate Cancer

Treatments: Radiation: HDR brachytherapy monotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02077335

CSSSG-001

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

HDR brachytherapy monotherapy

Experimental group

Description:

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.

Treatment:

Radiation: HDR brachytherapy monotherapy