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

This study has been terminated.
(Higher then expected Gr3 GU/GI toxicity)
Sponsor:
Information provided by (Responsible Party):
George Rodrigues, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01439542
First received: September 21, 2011
Last updated: July 22, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Radiation: Stereotactic Body Radiation
Drug: Luteinizing Hormone Releasing Hormone (LHRH) Agonist
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: FASTR: Fairly Brief Androgen Suppression and Stereotactic Radiotherapy for High Risk Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Toxicity [ Time Frame: year 1 of follow-up ] [ Designated as safety issue: Yes ]
    Assessment of late genitourinary and gastrointestinal toxicity at 1 year as assessed by the Common Toxicity Criteria

  • Toxicity [ Time Frame: year 2 of follow-up ] [ Designated as safety issue: Yes ]
    Assessment of late genitourinary amd gastrointestinal toxicity at 2 years as assessed by the Common Toxicity Criteria

  • Toxicity [ Time Frame: year 3 of follow-up ] [ Designated as safety issue: Yes ]
    Assessment of late genitourinary and gastrointestinal toxicity at year 3 as assessed by the Common Toxicity Criteria


Secondary Outcome Measures:
  • Disease Free Survival [ Time Frame: years 1, 2 and 3 of follow-up ] [ Designated as safety issue: No ]
    3 year disease free survival (defined by absence of clinical relapse and prostatic specific antigen (PSA) failure as per the ASTRO Phoenix definition

  • Quality of Life [ Time Frame: years 1, 2, and 3 of follow-up ] [ Designated as safety issue: No ]
    Quality of life as assessed by the Prostate Cancer Radiotherapy questionnaire


Enrollment: 19
Study Start Date: September 2011
Estimated Primary Completion Date: December 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01439542

Locations
Canada, Ontario
London Regional Cancer Program of the Lawson Health Research Institute
London, Ontario, Canada, N6A 4L6
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Glenn Bauman, MD London Regional Cancer Program of the Lawson Health Research Institute
Principal Investigator: George Rodrigues, MD London Regional Cancer Program of the Lawson Health Research Institute
  More Information

No publications provided

Responsible Party: George Rodrigues, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01439542     History of Changes
Other Study ID Numbers: R-11-220, FASTR
Study First Received: September 21, 2011
Last Updated: July 22, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Lawson Health Research Institute:
High risk prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 01, 2014