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

Sponsor
Sunnybrook Health Sciences Centre (Other)
Overall Status
Recruiting
CT.gov ID
NCT04245670
Collaborator
Prostate Cure Foundation (Other)
75
Enrollment
1
Location
1
Arm
80.1
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Radiation: Stereotactic Ablative Body Radiotherapy (SABR) 35-50 Gy/5
 N/A

Study Design

Study Type:
Interventional
Anticipated 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
Anticipated Primary Completion Date :
Aug 30, 2020
Anticipated Study Completion Date :
Jan 31, 2025

Arms and Interventions

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

Primary Outcome Measures

  1. Acute Toxicity [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 [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 [Baseline to end of 5 year follow up]

    Measuring quality of life using Expanded Prostate Index Composite (EPIC)

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

    Biochemical disease-free survival

  3. Quality of life outcome [Baseline to end of 5 year follow up]

    Health utilities using the EQ-5D Quality of Life Questionnaire tool

  4. Quality of life outcome [Baseline to end of 5 year follow up]

    Health utilities using PORPUS-U Quality of Life Questionnaire tool

  5. Economic analysis [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

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No

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

Locations

Site City State Country Postal Code
1 Sunnybrook Health Sciences Center Toronto Ontairo Canada M4N 3M5

Sponsors and Collaborators

  • Sunnybrook Health Sciences Centre
  • Prostate Cure Foundation

Investigators

  • Principal Investigator: Andrew Loblaw, MD, Sunnybrook Health Sciences Centre

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT04245670
Other Study ID Numbers:
  • 5STAR-PC
First Posted:
Jan 29, 2020
Last Update Posted:
Jan 29, 2020
Last Verified:
Jan 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Prostatic Neoplasms

Study Results

No Results Posted as of Jan 29, 2020