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A Trial Evaluating Toxicity of SBRT and LDRB in Localized Prostate Cancer.

Primary Purpose

Prostate Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Low-Dose Rate Brachytherapy to the prostate using Iodine-125 seed implant
Stereotactic Body Radiation Therapy to the prostate
Sponsored by
CHU de Quebec-Universite Laval
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Low-dose rate brachytherapy (LDRB), Stereotactic Body RadioTherapy (SBRT)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: 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]. Exclusion Criteria: Clinical or radiological evidence of metastatic disease or nodal involvement. Clinical stage ≥ T2b. Gleason score ≥ 4 + 3. Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, or other solid tumors curatively treated with no evidence of disease for ≥ 3 years. Prior radical surgery for carcinoma of the prostate, or prior TURP (Trans-Urethral Resection of the Prostate). Prior pelvic radiotherapy or prior radiotherapy that would result in overlap of radiation fields. Prior chemotherapy for prostate cancer, or prior chemotherapy within the last 3 years. Prior cryosurgery of the prostate. Prior or current bleeding diathesis making fiducial placement or brachytherapy procedure unsafe. Previous androgen deprivation therapy within 6 months of the registration. Bilateral hip prostheses Any severe active comorbidity, laboratory abnormality, psychiatric illnesses, active or uncontrolled infections, serious illnesses or medical conditions that would prevent the patient from participating or to be managed according to the protocol (according to investigator's decision). Such examples includes active inflammatory bowel disease, significant urinary symptoms,

Sites / Locations

  • Centre Intégré de Cancérologie, CHU de Québec-Université LavalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Low-Dose Rate Brachytherapy to the prostate using Iodine-125 seed implant

Stereotactic Body Radiation Therapy to the prostate

Arm Description

Low-Dose Rate Brachytherapy to the prostate using Iodine-125 seed implant to a total dose of 144 Gy.

Stereotactic Body Radiation Therapy to the prostate using 36.25 Gy in 5 fractions.

Outcomes

Primary Outcome Measures

Adverse Event Evaluation according to the CTCAE version 4 to assess non-inferiority of SBRT compared to LDRB.
Number of toxicities events assessed

Secondary Outcome Measures

Quality of life issues in patients with prostate cancer
Expanded Prostate Cancer Index Composite score (EPIC-26 questionnaire). In general terms, a higher score represents a better health-related quality of life.
Urinary function
International Prostate Symptom Score (IPSS score). The IPSS score is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms.
Absolute PSA nadir to evaluate biochemical disease free survival.
PSA measurements

Full Information

First Posted
September 8, 2023
Last Updated
September 21, 2023
Sponsor
CHU de Quebec-Universite Laval
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1. Study Identification

Unique Protocol Identification Number
NCT06052683
Brief Title
A Trial Evaluating Toxicity of SBRT and LDRB in Localized Prostate Cancer.
Official Title
A Randomized Trial Evaluating Toxicity of Stereotactic Body Radiotherapy (SBRT) and Low-dose Rate Brachytherapy (LDRB) in Localized Prostate Cancer.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 30, 2019 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
September 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHU de Quebec-Universite Laval

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 : 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)? 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.
Detailed Description
Low-dose rate brachytherapy (LDRB) using Iodine-125 seed implant is known to be an effective definitive treatment for patients with low and favourable intermediate-risk prostate cancer. Mature data from Canadian institutions reported a biochemical progression-free survival as high as 90-95% at 5-10 years for patients with low and intermediate risk disease. Prostate Stereotactic Body Radiotherapy (SBRT) as a single modality is a promising alternative to LDRB in low and favourable intermediate-risk prostate cancer. Some studies have shown the feasibility and efficacy of SBRT with low to intermediate risk-prostate cancer with 5-7 years PSA-progression-free survival really high (89,8% to 97,1% at a median follow-up of 5-7 years) [PSA: Prostate-Specific Antigen]. No randomized trial has yet compared LDRB to SBRT head to head. Acute urinary toxicity is not trivial: a few studies have shown correlation between late urinary toxicity and the presence of acute urinary toxicity in patients treated with LDRB. Our research hypothesis is that SBRT for low and intermediate risk will result in fewer toxicities at the genito-urinary and the gastro-intestinal levels after 3 months of treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Low-dose rate brachytherapy (LDRB), Stereotactic Body RadioTherapy (SBRT)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
For the pilot study, patients will be randomized to receive one of the following treatments to a planned sample size of 48 patients. 24 patients will be randomized in each treatment arms. Once the pilot study will be completed, the investigators will conduct the large-scale research study enrolling 208 patients
Masking
None (Open Label)
Allocation
Randomized
Enrollment
208 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low-Dose Rate Brachytherapy to the prostate using Iodine-125 seed implant
Arm Type
Active Comparator
Arm Description
Low-Dose Rate Brachytherapy to the prostate using Iodine-125 seed implant to a total dose of 144 Gy.
Arm Title
Stereotactic Body Radiation Therapy to the prostate
Arm Type
Experimental
Arm Description
Stereotactic Body Radiation Therapy to the prostate using 36.25 Gy in 5 fractions.
Intervention Type
Radiation
Intervention Name(s)
Low-Dose Rate Brachytherapy to the prostate using Iodine-125 seed implant
Intervention Description
Low-dose rate brachytherapy with Iodine-125 to a total dose of 144 Gy
Intervention Type
Radiation
Intervention Name(s)
Stereotactic Body Radiation Therapy to the prostate
Intervention Description
Prostate Stereotactic Body Radiation Therapy using 36.25 Gy in 5 fractions
Primary Outcome Measure Information:
Title
Adverse Event Evaluation according to the CTCAE version 4 to assess non-inferiority of SBRT compared to LDRB.
Description
Number of toxicities events assessed
Time Frame
1, 3, 6, 9, 12, 18, 24 months after end of treatment and yearly after, up to 5 years.
Secondary Outcome Measure Information:
Title
Quality of life issues in patients with prostate cancer
Description
Expanded Prostate Cancer Index Composite score (EPIC-26 questionnaire). In general terms, a higher score represents a better health-related quality of life.
Time Frame
At baseline, 3, 6, 9, 12, 18 and 24 months and then yearly after, up to 5 years.
Title
Urinary function
Description
International Prostate Symptom Score (IPSS score). The IPSS score is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms.
Time Frame
At baseline, 1, 3, 6. 9, 12, 18, 24 and 36 months after the procedure
Title
Absolute PSA nadir to evaluate biochemical disease free survival.
Description
PSA measurements
Time Frame
PSA measurement every 3 months after the procedure, during the first 3 years and then every 6 months, up to 5 years

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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]. Exclusion Criteria: Clinical or radiological evidence of metastatic disease or nodal involvement. Clinical stage ≥ T2b. Gleason score ≥ 4 + 3. Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, or other solid tumors curatively treated with no evidence of disease for ≥ 3 years. Prior radical surgery for carcinoma of the prostate, or prior TURP (Trans-Urethral Resection of the Prostate). Prior pelvic radiotherapy or prior radiotherapy that would result in overlap of radiation fields. Prior chemotherapy for prostate cancer, or prior chemotherapy within the last 3 years. Prior cryosurgery of the prostate. Prior or current bleeding diathesis making fiducial placement or brachytherapy procedure unsafe. Previous androgen deprivation therapy within 6 months of the registration. Bilateral hip prostheses Any severe active comorbidity, laboratory abnormality, psychiatric illnesses, active or uncontrolled infections, serious illnesses or medical conditions that would prevent the patient from participating or to be managed according to the protocol (according to investigator's decision). Such examples includes active inflammatory bowel disease, significant urinary symptoms,
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Isabelle Thibault, MD, FRCPC
Phone
418-525-4444
Ext
67296
Email
isabelle.thibault.med@ssss.gouv.qc.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Eric Vigneault, MD, FRCPC
Phone
418-525-4444
Ext
67296
Email
eric.vigneault.med@ssss.gouv.qc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabelle Thibault, MD, FRCPC
Organizational Affiliation
CHU de Québec-Université Laval
Official's Role
Study Chair
Facility Information:
Facility Name
Centre Intégré de Cancérologie, CHU de Québec-Université Laval
City
Québec
ZIP/Postal Code
G1J 1Z4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabelle Thibault, MD, FRCPC
Phone
418-525-4444
Ext
67296
Email
isabelle.thibault.med@ssss.gouv.qc.ca

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Trial Evaluating Toxicity of SBRT and LDRB in Localized Prostate Cancer.

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