Fairly Brief Androgen Suppression and Stereotactic Radiotherapy for High Risk Prostate Cancer - Protocol 2 (FASTR-2)

June 1, 2021 updated by: Glenn Bauman, Lawson Health Research Institute

This study will explore the combination of a stereotactic body radiation therapy (SBRT) approach combined with one year of luteinizing hormone releasing hormone (LHRH) agonist for older men with high risk prostate cancer, or men unwilling to undertake conventionally fractionated therapy and three years of adjuvant hormone therapy.

The purpose of this study is to examine the safety of a shorter course of radiation treatment combined wtih androgen deprivation therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Randomized controlled trials have established the improved efficacy (better biochemical control and disease free survival) of combined radical radiation (70-80 Gy over 7-8 weeks) combined with long term hormone therapy (2-3 years of adjuvant LHRH agonist) compared to a primary hormone therapy or radiation therapy alone in men with locally advanced/high risk disease. While this approach may be tolerable in fit individuals, this combination may not be well tolerated by frail individuals, or those who live at a distance who may find it difficult to attend for 7 weeks of radiation treatments. Those individuals with co-morbidities such as diabetes, coronary artery disease or osteoporosis may have those conditions exacerbated by long term hormone therapy.

The combination of short course radiation and hormone therapy was explored in the FASTR trial. As part of the trial, patients received 12 months of hormone therapy with radiation treatment to the pelvic lymph nodes (dose of 25 Gy in 5 fractions, 1 fraction per week) concomitant with radiation treatment to the prostate (dose of 40 Gy in 5 fractions, 1 fraction per week). The study was discontinued due to toxicity. For the FASTR-2 study, these concerns are being addressed through the use of a lower total dose to the prostate (35 Gy in 5 fractions, 1 fraction per week). Given the uncertainty of the benefit of pelvic nodal radiation in prostate cancer, it was decided to omit the pelvic nodal radiation in the FASTR-2 study. In addition, given the recent evidence supporting the equivalence of 18 months of hormone therapy, compared to 36 months, it was decided to lengthen the duration of hormone therapy in the FASTR-2 study to 18 months (versus 12 months in the FASTR study).

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 4L6
        • London Regional Cancer Program of the Lawson Health Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • High risk prostate cancer
  • Has had multidisciplinary consultation with radiation oncologist and urologist
  • Age >70 or refuses standard treatment
  • No evidence of extra-prostatic disease on screening bone scan and CT scan (non-contrast CT used for CT simulation acceptable)
  • Signed written and voluntary informed consent provided.
  • Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures

Exclusion Criteria:

  • Patients not meeting the eligibility criteria
  • Prior pelvic radiotherapy or brachytherapy
  • Use of anti-coagulation (low molecular weight heparin or Coumadin)
  • History of inflammatory bowel disease, Crohn's disease, diverticulitis or collagen vascular disease (other than rheumatoid arthritis)
  • Previous treatment for malignancy (other than basal or squamous cell skin cancer) within 3 years of prostate cancer diagnosis
  • patients on androgen deprivation therapy > 2 months prior to study enrolment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Radiation plus Androgen Supression
Radiation plus Androgen Suppression give as stereotactic radiation 7gray (Gy) per week x 5 weeks and leuprolide 45mg every 6 months for 18 months
Radiation: Radiation
Radiation: Radiotherapy 7 gray (Gy) per week over 5 weeks (35Gy)
Drug: Androgen Suppression
Leuprolide 45mg every 6 months for a total of 18 months
Other Names:
  • LHRH agonist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Genitourinary and Gastrointestinal Toxicity at 1 year
Time Frame: Year 1 of follow-up
Genitourinary and gastrointestinal toxicity measured at year 1 of follow-up using the Common Toxicity Criteria
Year 1 of follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease Free Survival at 3 years
Time Frame: 1, 2, and 3 years of follow-up
Defined by absence of clinical relapse and prostatic specific antigen (PSA) failure as per the American Society of Therapeutic Radiation and Oncology (ASTRO) Phoenix definition
1, 2, and 3 years of follow-up
Quality of Life
Time Frame: 1, 2, and 3 years of follow-up
Measured using the Prostate Cancer Radiotherapy questionnaire
1, 2, and 3 years of follow-up
Genitourinary and Gastrointestinal Toxicity at 2 years
Time Frame: Year 2 of follow-up

Genitourinary and gastrointestinal toxicity measured at year 2 of follow-up using the Common Toxicity Criteria

Safety Issue? (FDAAA) Yes
Year 2 of follow-up
Genitourinary and gastrointestinal toxicity measured at 3 years
Time Frame: Year 3 of follow-up
Genitourinary and gastrointestinal toxicity measured at year 3 of follow-up using the Common Toxicity Criteria
Year 3 of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lawson Health Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

June 1, 2021

Study Registration Dates

First Submitted

August 27, 2014

First Submitted That Met QC Criteria

August 28, 2014

First Posted (Estimate)

September 1, 2014

Study Record Updates

Last Update Posted (Actual)

June 4, 2021

Last Update Submitted That Met QC Criteria

June 1, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FASTR-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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