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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 : Recruiting
First Posted : September 1, 2014
Last Update Posted : March 6, 2018
Sponsor:
Information provided by (Responsible Party):
Glenn Bauman, Lawson Health Research Institute

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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: Radiation Drug: Androgen Suppression Phase 2

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  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fairly Brief Androgen Suppression and Stereotactic Radiotherapy for High Risk Prostate Cancer - Protocol 2
Study Start Date : December 2014
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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 Name: LHRH agonist




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Quality of Life [ Time Frame: 1, 2, and 3 years of follow-up ]
    Measured using the Prostate Cancer Radiotherapy questionnaire

  3. 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


  4. 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



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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02229734


Contacts
Contact: Glenn Bauman, MD 519-685-8650 Glenn.Bauman@lhsc.on.ca

Locations
Canada, Ontario
London Regional Cancer Program of the Lawson Health Research Institute Recruiting
London, Ontario, Canada, N6A 4L6
Contact: Glenn Bauman, MD    519-685-8650    Glenn.Bauman@lhsc.on.ca   
Principal Investigator: Glenn Bauman, MD         
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Glenn Bauman, MD London Regional Cancer Program of the Lawson Health Research Institute

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Glenn Bauman, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT02229734     History of Changes
Other Study ID Numbers: FASTR-2
First Posted: September 1, 2014    Key Record Dates
Last Update Posted: March 6, 2018
Last Verified: March 2018

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