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

NCT02229734 | Completed Phase 2 DMC

• 1 other identifier: FASTR-2
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Genitourinary and Gastrointestinal Toxicity at 1 year

  Genitourinary and gastrointestinal toxicity measured at year 1 of follow-up using the Common Toxicity Criteria

  Year 1 of follow-up

Secondary Outcomes (4)

• Disease Free Survival at 3 years

  1, 2, and 3 years of follow-up

• Quality of Life

  1, 2, and 3 years of follow-up

• Genitourinary and Gastrointestinal Toxicity at 2 years

  Year 2 of follow-up

• Genitourinary and gastrointestinal toxicity measured at 3 years

  Year 3 of follow-up

Study Arms (1)

Radiation plus Androgen Supression

EXPERIMENTAL

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; Drug: Androgen Suppression

Interventions

Radiation RADIATION

Radiation: Radiotherapy 7 gray (Gy) per week over 5 weeks (35Gy)

Radiation plus Androgen Supression

Androgen Suppression DRUG

Leuprolide 45mg every 6 months for a total of 18 months

Also known as: LHRH agonist

Radiation plus Androgen Supression

Eligibility Criteria

• Age: 70 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

London Regional Cancer Program of the Lawson Health Research Institute

London, Ontario, N6A 4L6, Canada

Location

Related Publications (1)

• 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.

  PMID: 25936597 DERIVED

Related Links

• Preliminary Results and Toxicity Analysis

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiation; Gonadotropin-Releasing Hormone

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Physical Phenomena; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Glenn Bauman, MD

  London Regional Cancer Program of the Lawson Health Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 27, 2014
• First Posted: September 1, 2014
• Study Start: December 1, 2014
• Primary Completion: August 1, 2017
• Study Completion: June 1, 2021
• Last Updated: June 4, 2021

Record last verified: 2021-06

Locations

CA (1)