NCT01578902

Brief Summary

The purpose of this study is to determine the safety and efficacy of a short course of radiotherapy (35 Gy / 5 fractions / 29 days) for the treatment of low-risk prostate cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable prostate-cancer

Timeline
Completed

Started Oct 2006

Longer than P75 for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

October 31, 2011

Completed
6 months until next milestone

First Posted

Study publicly available on registry

April 17, 2012

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
7.7 years until next milestone

Results Posted

Study results publicly available

December 17, 2020

Completed
Last Updated

December 17, 2020

Status Verified

November 1, 2020

Enrollment Period

1.5 years

First QC Date

October 31, 2011

Results QC Date

October 12, 2017

Last Update Submit

November 23, 2020

Conditions

Prostate Cancer

Keywords

Prostatic NeoplasmsRadiotherapyHypofractionationLow Risk Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Incidence of Grade 3+ Gastrointestinal Toxicity

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

    Acute period (up to 6 months)

Secondary Outcomes (5)

  • Incidence of Grade 3+ Genitourinary Toxicity

    Acute (up to 6 months) and Late (6 months and after)

  • Incidence of Grade 3+ Rectal and Urinary Toxicity

    Late (6 months and after)

  • Patient Reported Quality of Life

    up to 5 years

  • Biochemical (ie. Prostate Specific Antigen) Disease Free Survival

    5 year

  • Biopsy Positive Rate

    3 year

Study Arms (1)

Hypofractionated radiotherapy using SABR

EXPERIMENTAL

Stereotactic radiation: 35Gy in 5 fractions over 29 days

Radiation: Stereotactic ablative body radiotherapy

Interventions

Stereotactic ablative body radiotherapyRADIATION

35Gy/5 fractions/29 days

Also known as: standard linear accelerator delivery
Hypofractionated radiotherapy using SABR

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Informed consent signed (Appendix A)
  • Adult men greater than 18 years of age
  • Histologically confirmed diagnosis of adenocarcinoma of the prostate (centrally reviewed).
  • Clinical stage T1-T2b, Gleason Score \< 6, and PSA \< 10 ng/mL
  • Less than 50% of biopsy cores +ve for cancer
  • Less than 50% overall surface area involved with cancer
  • Neoadjuvant hormone suppression therapy is allowed. However, PSA, must have been performed within 2 months of starting androgen suppression therapy. If androgen suppression therapy has been started LHRH agonist must be continued for a minimum of 3 months before initiation of gold fiducial marker insertion \& radiotherapy planning.

You may not qualify if:

  • Prior pelvic radiotherapy.
  • Concurrent anticoagulation medication (if it is unsafe to discontinue for gold seed insertion)
  • Diagnosis of bleeding diathesis
  • Presence of a hip prosthesis
  • Pelvic girth \>40cm (to ensure visibility of gold seeds on electronic portal imaging device)
  • Large prostate (\> 60 cm3) on imaging
  • Severe lower urinary tract symptoms (International Prostate Symptom Score \> 15 or nocturia \> 3)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Related Publications (1)

  • Quon HC, Musunuru HB, Cheung P, Pang G, Mamedov A, D'Alimonte L, Deabreu A, Zhang L, Loblaw A. Dose-Escalated Stereotactic Body Radiation Therapy for Prostate Cancer: Quality-of-Life Comparison of Two Prospective Trials. Front Oncol. 2016 Aug 29;6:185. doi: 10.3389/fonc.2016.00185. eCollection 2016.

    PMID: 27622157DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Results Point of Contact

Title
Dr Andrew Loblaw, Director GU Radiation Trials
Organization
Sunnybrook Research Institute
andrew.loblaw@sunnybrook.ca
4164804806

Study Officials

  • Andrew Loblaw, MD

    Sunnybrook Health Sciences Centre

    PRINCIPAL INVESTIGATOR

  • Patrick Cheung, MD

    Sunnybrook Health Sciences Centre

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2011

First Posted

April 17, 2012

Study Start

October 1, 2006

Primary Completion

April 1, 2008

Study Completion

April 1, 2013

Last Updated

December 17, 2020

Results First Posted

December 17, 2020

Record last verified: 2020-11

Locations

CA(1)