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Trial record 6 of 1546 for:    Androgens

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

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ClinicalTrials.gov Identifier: NCT02229734
Recruitment Status : Active, not recruiting
First Posted : September 1, 2014
Last Update Posted : June 25, 2019
Sponsor:
Information provided by (Responsible Party):
Glenn Bauman, Lawson Health Research Institute

Tracking Information
First Submitted Date  ICMJE August 27, 2014
First Posted Date  ICMJE September 1, 2014
Last Update Posted Date June 25, 2019
Study Start Date  ICMJE December 2014
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 28, 2014)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02229734 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 28, 2014)
  • 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
  • Quality of Life [ Time Frame: 1, 2, and 3 years of follow-up ]
    Measured using the Prostate Cancer Radiotherapy questionnaire
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fairly Brief Androgen Suppression and Stereotactic Radiotherapy for High Risk Prostate Cancer - Protocol 2
Official Title  ICMJE Fairly Brief Androgen Suppression and Stereotactic Radiotherapy for High Risk Prostate Cancer - Protocol 2
Brief Summary

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.

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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • 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 Name: LHRH agonist
Study Arms  ICMJE 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
Interventions:
  • Radiation: Radiation
  • Drug: Androgen Suppression
Publications * Bauman G, Ferguson M, Lock M, Chen J, Ahmad B, Venkatesan VM, Sexton T, D'Souza D, Loblaw A, Warner A, Rodrigues G. A Phase 1/2 Trial of Brief Androgen Suppression and Stereotactic Radiation Therapy (FASTR) for High-Risk Prostate Cancer. Int J Radiat Oncol Biol Phys. 2015 Jul 15;92(4):856-62. doi: 10.1016/j.ijrobp.2015.02.046. Epub 2015 Apr 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: August 28, 2014)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2019
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 70 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02229734
Other Study ID Numbers  ICMJE FASTR-2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Glenn Bauman, Lawson Health Research Institute
Study Sponsor  ICMJE Lawson Health Research Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Glenn Bauman, MD London Regional Cancer Program of the Lawson Health Research Institute
PRS Account Lawson Health Research Institute
Verification Date June 2019

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