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5 Fractions of Pelvic SABR With Intra Prostatic SABR Boost: (5STAR-PC)

Primary Purpose

Prostate Cancer

Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Stereotactic Ablative Body Radiotherapy (SABR) 35-50 Gy/5
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

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

Inclusion Criteria

  • Histologically confirmed prostate adenocarcinoma (centrally reviewed)
  • High-intermediate risk defined as two or more of: T2c, Gleason 7 OR PSA 10-20ng/ml,
  • High-risk prostate cancer, defined as at least one of: T3, Gleason 8-10, OR PSA > 20 ng/mL
  • Willing to give informed consent to participate in this clinical trial
  • Able and willing to complete EPIC, PORPUS and EQ-5D questionnaires

Exclusion Criteria

  • Prior pelvic radiotherapy
  • Contraindication to radical prostate radiotherapy e.g. connective tissue disease or inflammatory bowel disease
  • Anticoagulation medication (if unsafe to discontinue for fiducial insertion)
  • Diagnosis of bleeding diathesis
  • Poor baseline urinary function defined as International Prostate Symptom Score (IPSS) >20
  • Evidence of castrate resistance (defined as PSA < 3 ng/ml while testosterone is < 0.7nmol/l. Patients could have been on combined androgen blockade but are excluded if this was started due to PSA progression.
  • Definitive extrapelvic nodal or distant metastatic disease on staging investigations.
  • Hip prosthesis

Sites / Locations

  • Sunnybrook Health Sciences Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stereotactic Ablative Body Radiotherapy (SABR) 35-50 Gy/5

Arm Description

Stereotactic Ablative Body Radiotherapy (SABR) given in 5 weekly fractions. Simultaneously treating the pelvic lymph nodes, prostate and MRI-nodule to a total dose of 25 Gy, 35 Gy and up to 50 Gy, respectively. The radiation will be given with 6-18 months of ADT.

Outcomes

Primary Outcome Measures

Acute Toxicity
To document the acute urinary toxicity using the Common Terminology Criteria for Adverse Events (CTCAE v4.0) criteria
Acute Toxicity
To document the acute bowel toxicity using the Common Terminology Criteria for Adverse Events (CTCAE v4.0) criteria

Secondary Outcome Measures

Quality of Life outcome
Measuring quality of life using Expanded Prostate Index Composite (EPIC)
Biochemical disease-free survival
Biochemical disease-free survival
Quality of life outcome
Health utilities using the EQ-5D Quality of Life Questionnaire tool
Quality of life outcome
Health utilities using PORPUS-U Quality of Life Questionnaire tool
Economic analysis
Cost effectiveness of treatment.Quality of life and cost estimates will be captured for each patient from time of the initiation of treatment until death. The effectiveness endpoints will be biochemical disease free survival and quality-adjusted life years (QALYs). QALY will be calculated by survival (in years) multiplied by a utility weight associated with a certain condition.

Full Information

First Posted
January 27, 2020
Last Updated
September 27, 2022
Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Prostate Cure Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04245670
Brief Title
5 Fractions of Pelvic SABR With Intra Prostatic SABR Boost:
Acronym
5STAR-PC
Official Title
5 Fractions of Pelvic SABR With Intra Prostatic SABR Boost:A Phase II Study (5STAR-PC)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 31, 2018 (Actual)
Primary Completion Date
August 30, 2021 (Actual)
Study Completion Date
January 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Prostate Cure Foundation

4. Oversight

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

5. Study Description

Brief Summary
Stereotactic Ablative Body Radiotherapy (SABR) given in 5 weekly fractions. Simultaneously treating the pelvic lymph nodes, prostate and MRI-nodule to a total dose of 25 Gy, 35 Gy and up to 50 Gy, respectively. The radiation will be given with 6-18 months of ADT. 5-fraction SABR is a feasible, well-tolerated, effective and cost effective treatment for high-intermediate and high risk prostate cancer with/without an image-guided intraprostatic boost.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stereotactic Ablative Body Radiotherapy (SABR) 35-50 Gy/5
Arm Type
Experimental
Arm Description
Stereotactic Ablative Body Radiotherapy (SABR) given in 5 weekly fractions. Simultaneously treating the pelvic lymph nodes, prostate and MRI-nodule to a total dose of 25 Gy, 35 Gy and up to 50 Gy, respectively. The radiation will be given with 6-18 months of ADT.
Intervention Type
Radiation
Intervention Name(s)
Stereotactic Ablative Body Radiotherapy (SABR) 35-50 Gy/5
Intervention Description
Stereotactic Ablative Body Radiotherapy (SABR) given in 5 weekly fractions. Simultaneously treating the pelvic lymph nodes, prostate and MRI-nodule to a total dose of 25 Gy, 35 Gy and up to 50 Gy, respectively. The radiation will be given with 6-18 months of ADT.
Primary Outcome Measure Information:
Title
Acute Toxicity
Description
To document the acute urinary toxicity using the Common Terminology Criteria for Adverse Events (CTCAE v4.0) criteria
Time Frame
Baseline to 3 months post completion of treatment
Title
Acute Toxicity
Description
To document the acute bowel toxicity using the Common Terminology Criteria for Adverse Events (CTCAE v4.0) criteria
Time Frame
Baseline to 3 months post completion of treatment
Secondary Outcome Measure Information:
Title
Quality of Life outcome
Description
Measuring quality of life using Expanded Prostate Index Composite (EPIC)
Time Frame
Baseline to end of 5 year follow up
Title
Biochemical disease-free survival
Description
Biochemical disease-free survival
Time Frame
Baseline to end of 5 year follow up
Title
Quality of life outcome
Description
Health utilities using the EQ-5D Quality of Life Questionnaire tool
Time Frame
Baseline to end of 5 year follow up
Title
Quality of life outcome
Description
Health utilities using PORPUS-U Quality of Life Questionnaire tool
Time Frame
Baseline to end of 5 year follow up
Title
Economic analysis
Description
Cost effectiveness of treatment.Quality of life and cost estimates will be captured for each patient from time of the initiation of treatment until death. The effectiveness endpoints will be biochemical disease free survival and quality-adjusted life years (QALYs). QALY will be calculated by survival (in years) multiplied by a utility weight associated with a certain condition.
Time Frame
Baseline to end of 5 year follow up

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Male patients with Prostate cancer
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Histologically confirmed prostate adenocarcinoma (centrally reviewed) High-intermediate risk defined as two or more of: T2c, Gleason 7 OR PSA 10-20ng/ml, High-risk prostate cancer, defined as at least one of: T3, Gleason 8-10, OR PSA > 20 ng/mL Willing to give informed consent to participate in this clinical trial Able and willing to complete EPIC, PORPUS and EQ-5D questionnaires Exclusion Criteria Prior pelvic radiotherapy Contraindication to radical prostate radiotherapy e.g. connective tissue disease or inflammatory bowel disease Anticoagulation medication (if unsafe to discontinue for fiducial insertion) Diagnosis of bleeding diathesis Poor baseline urinary function defined as International Prostate Symptom Score (IPSS) >20 Evidence of castrate resistance (defined as PSA < 3 ng/ml while testosterone is < 0.7nmol/l. Patients could have been on combined androgen blockade but are excluded if this was started due to PSA progression. Definitive extrapelvic nodal or distant metastatic disease on staging investigations. Hip prosthesis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Loblaw, MD
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Health Sciences Center
City
Toronto
State/Province
Ontairo
ZIP/Postal Code
M4N 3M5
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
Analysis of acute toxicity will be performed approximately 6 months after the last patient has been accrued, in August 2020. The final analysis will be performed when all patients have completed 5 years of follow-up, in early 2025.
IPD Sharing Access Criteria
The primary endpoint analysis will be shared thru publications

Learn more about this trial

5 Fractions of Pelvic SABR With Intra Prostatic SABR Boost:

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