NCT01423474

Brief Summary

The purpose of this study is to compare the toxicity of two new radiation schedules for the treatment of prostate cancer. Patients will be randomized to receive 5 treatments delivered every other day over 11 days, or once per week over 29 days. Both of these schedules are shorter than the standard treatment which is usually 39 treatments over 8 weeks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
152

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

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

First Submitted

Initial submission to the registry

August 23, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 26, 2011

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

February 23, 2024

Status Verified

February 1, 2024

Enrollment Period

7.6 years

First QC Date

August 23, 2011

Last Update Submit

February 22, 2024

Conditions

Prostatic Neoplasms

Keywords

RadiotherapyHypofractionation

Outcome Measures

Primary Outcomes (1)

  • Bowel related quality-of-life

    3 months

Secondary Outcomes (5)

  • Gastrointestinal toxicity

    During radiotherapy, at 3 and 6 months, then every 6 months after

  • Genitourinary toxicity

    During radiotherapy, at 3 and 6 months, then every 6 months after

  • PSA relapse rate

    3 and 5 years

  • Patient Overall Quality of life

    During radiotherapy, at 3 and 6 months, then every 6 months after

  • Salvage androgen deprivation therapy rate

    3 and 5 years

Study Arms (2)

Short treatment time (11 days)

EXPERIMENTAL
Radiation: Image-guided radiotherapy

Long treatment time (29 days)

EXPERIMENTAL
Radiation: Image-guided radiotherapy

Interventions

Image-guided radiotherapyRADIATION

40 Gy / 5 fractions / 11 days

Short treatment time (11 days)

Eligibility Criteria

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

You may qualify if:

  • Low or intermediate risk prostate cancer patients as defined by:
  • Clinical stage T1-2b, Gleason Score \<=7, and PSA \<=20 ng/mL
  • Age \>= 18 years

You may not qualify if:

  • Androgen deprivation therapy (LHRH-agonists or antiandrogens) \>6 months
  • Prior pelvic radiotherapy
  • Anticoagulation medication (if unsafe to discontinue for gold seed insertion)
  • Diagnosis of bleeding diathesis
  • Large prostate (\>90cm3) on imaging
  • Immunosuppressive medications
  • Inflammatory bowel disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

BC Cancer Agency - Abbotsford Centre

Abbotsford, British Columbia, V2S 0C2, Canada

Location

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Related Publications (2)

  • Ong WL, Quon H, Ong A, Cheung P, Chu W, Chung H, Vesprini D, Chowdhury A, Panjwani D, Alayed Y, Pang G, Korol R, Davidson M, Ravi A, McCurdy B, Zhang L, Kulasingham-Poon M, Mamedov A, Deabreu A, Loblaw A. Every Other Day or Once a Week: Long-term Oncological Outcomes in the Phase 2 PATRIOT Trial of Prostate Stereotactic Ablative Body Radiotherapy. Eur Urol Oncol. 2025 Aug;8(4):909-913. doi: 10.1016/j.euo.2025.03.011. Epub 2025 Apr 26.

    PMID: 40288917DERIVED

  • Quon HC, Ong A, Cheung P, Chu W, Chung HT, Vesprini D, Chowdhury A, Panjwani D, Pang G, Korol R, Davidson M, Ravi A, McCurdy B, Zhang L, Mamedov A, Deabreu A, Loblaw A. Once-weekly versus every-other-day stereotactic body radiotherapy in patients with prostate cancer (PATRIOT): A phase 2 randomized trial. Radiother Oncol. 2018 May;127(2):206-212. doi: 10.1016/j.radonc.2018.02.029. Epub 2018 Mar 15.

    PMID: 29551231DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiotherapy, Image-Guided

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeutics

Study Officials

  • Aldrich Ong, MD

    CancerCare Manitoba

    PRINCIPAL INVESTIGATOR

  • Andrew Loblaw, MD

    Sunnybrook Health Sciences Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Radiation Oncologist

Study Record Dates

First Submitted

August 23, 2011

First Posted

August 26, 2011

Study Start

January 1, 2012

Primary Completion

August 1, 2019

Study Completion

August 1, 2019

Last Updated

February 23, 2024

Record last verified: 2024-02

Locations

CA(3)