Safety and Efficacy Study of Hypofractionated Radiotherapy and Androgen Deprivation Therapy for Prostate Cancer

NCT01505075 | Unknown Phase 1 DMC

• 1 other identifier: 043-2011
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the safety and efficacy of a short course of radiotherapy (40Gy/5 fractions/29 days) for the treatment of high risk prostate cancer currently being managed with primary androgen deprivation therapy (PADT).

Conditions

Prostate Cancer

Keywords

prostatic neoplasms; radiotherapy; hypofractionated; high risk prostate cancer

Outcome Measures

Primary Outcomes (1)

• Incidence of grade 3+ rectal toxicity

  Common Terminology Criteria for Adverse Events (CTCAE) v3.0

  Acute period (up to 3 months)

Secondary Outcomes (4)

• Incidence of grade 3+ urinary toxicity

  Acute (up to 3 months) and Late (after 6 months of follow-up)

• Quality of Life

  5 years

• Biochemical (ie.prostate specific antigen) disease free survival

  5 years

• Incidence of grade 3+ rectal toxicity

  Late (after 6 months of follow-up)

Study Arms (1)

Hypofractionated radiation

EXPERIMENTAL

40 Gy in 5 fractions over 29 to prostate; 30 Gy in 5 fractions over 29 days to seminal vesicles

Radiation: Hypofractionated radiation

Interventions

Hypofractionated radiation RADIATION

40 Gy in 5 fractions to prostate, 30 Gy in 5 fractions to seminal vesicles; total treatment duration 29 days

Also known as: RapidArc

Hypofractionated radiation

Eligibility Criteria

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

You may qualify if:

• informed consent obtained
• men \> 18 years
• histologically confirmed prostate adenocarcinoma (centrally reviewed)
• high risk prostate cancer, defined as at least one of: clinical stage T3, or gleason score 8-10, or PSA \> 20ng/mL

You may not qualify if:

• prior pelvic radiotherapy
• anticoagulation medication (if unsafe to discontinue for gold seed insertion)
• diagnosis of bleeding diathesis
• pelvic girth \> 40cm (to ensure visibility of gold seeds on electronic portal imaging)
• large prostate (\> 90cm3) on imaging
• severe lower urinary tract symptoms (International Prostate Symptom Score \>19 or nocturia \> 3)
• No evidence of castrate resistance (defined as PSA \< 3ng/mL while testosterone is \< 0.7nmol/L). Patients could have been on combined androgen blockade but are excluded if this was started due to PSA progression

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Odette Cancer Centre, Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiation Dose Hypofractionation

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)

Dose Fractionation, Radiation; Radiotherapy Dosage; Radiotherapy; Therapeutics

Study Officials

• Andrew Loblaw, MD, FRCPC

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

• Suneil Jain, MD

  suneil.jain@sunnybrook.ca

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2011
• First Posted: January 6, 2012
• Study Start: September 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: September 1, 2021
• Last Updated: November 24, 2020

Record last verified: 2020-11

Locations

CA (1)