A Randomized Trial Evaluating Toxicity of Stereotactic Body Radiotherapy (SBRT) and Low-dose Rate Brachytherapy (LDRB) in Localized Prostate Cancer.

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this clinical trial is to compare SBRT (Stereotactic Body RadioTherapy) to LDRB (Low-Dose Rate Brachytherapy with Iodine-125 seed implant) in patients with low and favourable intermediate-risk prostate cancer. The two main questions it aims to answer are : 1. Does SBRT (Stereotactic Body RadioTherapy) for low and intermediate risk prostate cancer patients will result in less genito-urinary (GU) and gastro-intestinal (GI) toxicities than LDRB (Low-Dose Rate Brachytherapy)? 2. Does prostate cancer patients treated by SBRT have a better quality of life than patients treated by LDRB No randomized trial has yet compared LDRB to SBRT head to head.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• Histologically confirmed adenocarcinoma of the prostate diagnosed within the last 8 months. Patients on active surveillance with evidence of disease progression are eligible to the protocol as long as they meet the eligibility criteria and have a recent prostate biopsy (within 8 months).

• Low-risk and favourable intermediate-risk prostate cancer patients are eligible according to the following definitions:

‣ Low-risk disease defined as: Clinical stage T1-T2a and Gleason 6 and PSA ≤ 10 ng/mL

‣ Favourable intermediate-risk cancer defined by a single NCCN intermediate risk factor:

‣ \[NCCN : National Comprehensive Cancer Network\]

⁃ Clinical stage T2b

⁃ PSA \> 10 but ≤ 20 ng/mL

⁃ Gleason 7 (3+4)

‣ Lymph node evaluation by either computed tomography (CT) or magnetic resonance imaging (MRI) is optional and is left at the discretion of the treating physician.

• Age ≥ 18 years

• Eastern Cooperative Oncology Group performance status 0-1

• Patient considered medically fit for LDR brachytherapy

• Prostate volume ≤ 60 cc, measured by Trans-Rectal UltraSound (TRUS), CT or MRI, within the last 6 months.

• International Prostate Symptom Score (IPSS) ≤ 20 (alpha blockers allowed)

• No alpha reductase inhibitors use within two weeks of randomization

• No hormonal therapy is accepted

• Patients must provide a study-specified informed consent form prior to study entry.

• Patients must be willing and able to complete the EPIC-26, IPSS and SHIM questionnaires.

‣ \[EPIC-26: Expanded Prostate Cancer Index Composite score ; SHIM: Sexual Health Inventory for Men questionnaire\].

Locations
Other Locations
Canada
Centre Intégré de Cancérologie, CHU de Québec-Université Laval
RECRUITING
Québec
Contact Information
Primary
Isabelle Thibault, MD, FRCPC
isabelle.thibault.med@ssss.gouv.qc.ca
418-525-4444
Backup
Eric Vigneault, MD, FRCPC
eric.vigneault.med@ssss.gouv.qc.ca
418-525-4444
Time Frame
Start Date: 2019-09-30
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 208
Treatments
Active_comparator: Low-Dose Rate Brachytherapy to the prostate using Iodine-125 seed implant
Low-Dose Rate Brachytherapy to the prostate using Iodine-125 seed implant to a total dose of 144 Gy.
Experimental: Stereotactic Body Radiation Therapy to the prostate
Stereotactic Body Radiation Therapy to the prostate using 36.25 Gy in 5 fractions.
Related Therapeutic Areas
Sponsors
Leads: CHU de Quebec-Universite Laval

This content was sourced from clinicaltrials.gov