FASTR: Fairly Brief Androgen Suppression and Stereotactic Radiotherapy for High Risk Prostate Cancer (FASTR)

August 8, 2018 updated by: George Rodrigues, Lawson Health Research Institute
The purpose of this study is to examine the safety of a shorter course of radiation treatments combined with one year of androgen deprivation therapy. The study will test this treatment in men with high risk prostate cancer who have significant other illnesses or circumstances such that conventional long term radiotherapy and hormone therapy is not recommended by their physician or desired by the patient.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Randomized controlled trials have established the improved efficacy (better biochemical control and disease free survival) of combined radical radiation (70-80Gy/7-8 weeks) combined with long term hormone therapy (2-3 years of adjuvant luteinizing hormone releasing hormone (LHRH) agonist) compared to a primary hormone therapy or radiotherapy 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 due to travel considerations. Those individuals with co-morbidities such as diabetes, coronary artery disease or osteoporosis may have those conditions exacerbated by long term hormone therapy.

This pilot study will explore the combination of a stereotactic body radiotherapy (SBRT) approach (designed to be iso-effective for late effects for standard radiotherapy) combined with one year of LHRH agonist for older men with high risk disease who are less fit (Vulnerable Elderly Score > 3) or men unwilling to undertake conventionally fractionated therapy and three years of adjuvant hormone therapy.

Study Type

Interventional

Enrollment (Actual)

19

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • High risk prostate cancer:

    • clinical stage T3 (cT3) prostate cancer or
    • pre-treatment PSA > 20 or
    • Gleason score>8 on Trans-Rectal Ultrasound (TRUS) biopsy
  • Score of > 3 on the Vulnerable Elderly Scale or refuses standard radiotherapy + androgen deprivation therapy
  • No evidence of extra-prostatic disease on screening bone scan and Computed Tomography (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
  • Age ≥ 18 years

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

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: Radiotherapy
Radiation: Stereotactic Body Radiation

Clinical Target Volume 1 (CTV1): 25 Gy to nodes in 5 fractions, 1 fraction per week

Clinical Target Volume 2 (CTV2): 40 Gy to prostate and seminal vesicles in 5 fractions, 1 fraction per week

Drug: Luteinizing Hormone Releasing Hormone (LHRH) Agonist
12 months (2x6 month depot) of androgen suppression with LHRH agonist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Toxicity
Time Frame: year 1 of follow-up
Assessment of late genitourinary and gastrointestinal toxicity at 1 year as assessed by the Common Toxicity Criteria
year 1 of follow-up
Toxicity
Time Frame: year 2 of follow-up
Assessment of late genitourinary amd gastrointestinal toxicity at 2 years as assessed by the Common Toxicity Criteria
year 2 of follow-up
Toxicity
Time Frame: year 3 of follow-up
Assessment of late genitourinary and gastrointestinal toxicity at year 3 as assessed by the Common Toxicity Criteria
year 3 of follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease Free Survival
Time Frame: years 1, 2 and 3 of follow-up
3 year disease free survival (defined by absence of clinical relapse and prostatic specific antigen (PSA) failure as per the ASTRO Phoenix definition
years 1, 2 and 3 of follow-up
Quality of Life
Time Frame: years 1, 2, and 3 of follow-up
Quality of life as assessed by the Prostate Cancer Radiotherapy questionnaire
years 1, 2, and 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

Investigators

  • Principal Investigator: George Rodrigues, MD, London Regional Cancer Program of the 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

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

September 1, 2011

Primary Completion (Actual)

November 1, 2017

Study Completion (Actual)

November 1, 2017

Study Registration Dates

First Submitted

September 21, 2011

First Submitted That Met QC Criteria

September 22, 2011

First Posted (Estimate)

September 23, 2011

Study Record Updates

Last Update Posted (Actual)

August 9, 2018

Last Update Submitted That Met QC Criteria

August 8, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R-11-220
  • FASTR (Other Identifier: Principal Investigator)

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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