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

NCT01439542 | Terminated Phase 2 DMC

• 2 other identifiers: R-11-220FASTR
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

High risk prostate cancer

Outcome Measures

Primary Outcomes (3)

• Toxicity

  Assessment of late genitourinary and gastrointestinal toxicity at 1 year as assessed by the Common Toxicity Criteria

  year 1 of follow-up

• Toxicity

  Assessment of late genitourinary amd gastrointestinal toxicity at 2 years as assessed by the Common Toxicity Criteria

  year 2 of follow-up

• Toxicity

  Assessment of late genitourinary and gastrointestinal toxicity at year 3 as assessed by the Common Toxicity Criteria

  year 3 of follow-up

Secondary Outcomes (2)

• Disease Free Survival

  years 1, 2 and 3 of follow-up

• Quality of Life

  years 1, 2, and 3 of follow-up

Study Arms (1)

Radiotherapy

EXPERIMENTAL

Radiation: Stereotactic Body Radiation; Drug: Luteinizing Hormone Releasing Hormone (LHRH) Agonist

Interventions

Stereotactic Body Radiation 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

Radiotherapy

Luteinizing Hormone Releasing Hormone (LHRH) Agonist DRUG

12 months (2x6 month depot) of androgen suppression with LHRH agonist

Radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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

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

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiosurgery; 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)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques; 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

• George Rodrigues, 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: September 21, 2011
• First Posted: September 23, 2011
• Study Start: September 1, 2011
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: August 9, 2018

Record last verified: 2018-08

Locations

CA (1)