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

This study is currently recruiting participants.
Verified December 2013 by Lawson Health Research Institute
Sponsor:
Information provided by (Responsible Party):
George Rodrigues, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01439542
First received: September 21, 2011
Last updated: December 31, 2013
Last verified: December 2013

September 21, 2011
December 31, 2013
September 2011
December 2021   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01439542 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
FASTR: Fairly Brief Androgen Suppression and Stereotactic Radiotherapy for High Risk Prostate Cancer
FASTR: Fairly Brief Androgen Suppression and Stereotactic Radiotherapy for High Risk Prostate Cancer

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.

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
  • 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
Experimental: Radiotherapy
Interventions:
  • Radiation: Stereotactic Body Radiation
  • Drug: Luteinizing Hormone Releasing Hormone (LHRH) Agonist
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
Not Provided
December 2021   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact: Glenn Bauman, MD 519-685-8650 Glenn.Bauman@lhsc.on.ca
Contact: George Rodrigues, MD 519-685-8650 George.Rodrigues@lhsc.on.ca
Canada
 
NCT01439542
R-11-220, FASTR
Yes
George Rodrigues, Lawson Health Research Institute
Lawson Health Research Institute
Not Provided
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
Lawson Health Research Institute
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP