Prostate Accurately Targeted Radiotherapy Investigation of Overall Treatment Time

NCT ID: NCT01423474

Last Updated: 2024-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

152 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2019-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Prostatic Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Short treatment time (11 days)

Group Type EXPERIMENTAL

Image-guided radiotherapy

Intervention Type RADIATION

40 Gy / 5 fractions / 11 days

Long treatment time (29 days)

Group Type EXPERIMENTAL

Image-guided radiotherapy

Intervention Type RADIATION

40 Gy / 5 fractions / 29 days

Interventions

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Image-guided radiotherapy

40 Gy / 5 fractions / 11 days

Intervention Type RADIATION

Image-guided radiotherapy

40 Gy / 5 fractions / 29 days

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Sunnybrook Health Sciences Centre

OTHER

Sponsor Role collaborator

British Columbia Cancer Agency

OTHER

Sponsor Role collaborator

CancerCare Manitoba

OTHER

Sponsor Role lead

Responsible Party

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Dr. Aldrich Ong

Radiation Oncologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aldrich Ong, MD

Role: PRINCIPAL_INVESTIGATOR

CancerCare Manitoba

Andrew Loblaw, MD

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre

Locations

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BC Cancer Agency - Abbotsford Centre

Abbotsford, British Columbia, Canada

Site Status

CancerCare Manitoba

Winnipeg, Manitoba, Canada

Site Status

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 40288917 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29551231 (View on PubMed)

Other Identifiers

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50-2011

Identifier Type: -

Identifier Source: org_study_id

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