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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04245670
Recruitment Status : Recruiting
First Posted : January 29, 2020
Last Update Posted : January 29, 2020
Sponsor:
Collaborator:
Prostate Cure Foundation
Information provided by (Responsible Party):
Sunnybrook Health Sciences Centre

Study Description
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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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: Stereotactic Ablative Body Radiotherapy (SABR) 35-50 Gy/5 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 5 Fractions of Pelvic SABR With Intra Prostatic SABR Boost:A Phase II Study (5STAR-PC)
Actual Study Start Date : May 31, 2018
Estimated Primary Completion Date : August 30, 2020
Estimated Study Completion Date : January 31, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Stereotactic Ablative Body Radiotherapy (SABR) 35-50 Gy/5
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.
 Radiation: Stereotactic Ablative Body Radiotherapy (SABR) 35-50 Gy/5
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.


Outcome Measures
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Primary Outcome Measures :
  1. Acute Toxicity [ Time Frame: Baseline to 3 months post completion of treatment ]
    To document the acute urinary toxicity using the Common Terminology Criteria for Adverse Events (CTCAE v4.0) criteria

  2. Acute Toxicity [ Time Frame: Baseline to 3 months post completion of treatment ]
    To document the acute bowel toxicity using the Common Terminology Criteria for Adverse Events (CTCAE v4.0) criteria


Secondary Outcome Measures :
  1. Quality of Life outcome [ Time Frame: Baseline to end of 5 year follow up ]
    Measuring quality of life using Expanded Prostate Index Composite (EPIC)

  2. Biochemical disease-free survival [ Time Frame: Baseline to end of 5 year follow up ]
    Biochemical disease-free survival

  3. Quality of life outcome [ Time Frame: Baseline to end of 5 year follow up ]
    Health utilities using the EQ-5D Quality of Life Questionnaire tool

  4. Quality of life outcome [ Time Frame: Baseline to end of 5 year follow up ]
    Health utilities using PORPUS-U Quality of Life Questionnaire tool

  5. Economic analysis [ Time Frame: Baseline to end of 5 year follow up ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Male patients with Prostate cancer
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04245670


Contacts
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Contact: Andrew Loblaw, MD 416-480-5000 ext 4806 andrew.loblaw@sunnybrook.ca
Contact: Andrea DeAbreu 416-480-5000 ext 1058 andrea.deabreu@sunnybrook.ca

Locations
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Canada, Ontairo
Sunnybrook Health Sciences Center Recruiting
Toronto, Ontairo, Canada, M4N 3M5
Contact: Andrea DeAbreu    416-480-5000 ext 1058    andrea.deabreu@sunnybrook.ca   
Principal Investigator: Andrew Loblaw, MD         
Sub-Investigator: Gerard Morton, MD         
Sub-Investigator: Patrick Cheung, MD         
Sub-Investigator: William Chu, MD         
Sub-Investigator: Danny Vesprini, MD         
Sub-Investigator: Melanie Davidson, MD         
Sub-Investigator: Rene Korol, MD         
Sub-Investigator: Ananth Ravi, MD         
Sub-Investigator: Stanley Liu, MD         
Sub-Investigator: Eric Tseng, MD         
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Prostate Cure Foundation
Investigators
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Principal Investigator: Andrew Loblaw, MD Sunnybrook Health Sciences Centre
More Information
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Responsible Party: Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT04245670    
Other Study ID Numbers: 5STAR-PC
First Posted: January 29, 2020    Key Record Dates
Last Update Posted: January 29, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Clinical Study Report (CSR)
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.
Access Criteria: The primary endpoint analysis will be shared thru publications

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases