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

Prostate Cancer Clinical Trial

— FASTR  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01439542
• Other study ID #: R-11-220
• Secondary ID: FASTR
• Status: Terminated
• Phase: Phase 2
• Start date: September 2011
• Est. completion date: November 2017

Study information

• Verified date: August 2018
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Canada	London Regional Cancer Program of the Lawson Health Research Institute	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toxicity	Assessment of late genitourinary and gastrointestinal toxicity at 1 year as assessed by the Common Toxicity Criteria	year 1 of follow-up
Primary	Toxicity	Assessment of late genitourinary amd gastrointestinal toxicity at 2 years as assessed by the Common Toxicity Criteria	year 2 of follow-up
Primary	Toxicity	Assessment of late genitourinary and gastrointestinal toxicity at year 3 as assessed by the Common Toxicity Criteria	year 3 of follow-up
Secondary	Disease Free Survival	3 year disease free survival (defined by absence of clinical relapse and prostatic specific antigen (PSA) failure as per the ASTRO Phoenix definition	years 1, 2 and 3 of follow-up
Secondary	Quality of Life	Quality of life as assessed by the Prostate Cancer Radiotherapy questionnaire	years 1, 2, and 3 of follow-up