Safety and Efficacy Study of Dose-escalated Hypofractiona... | NCT01146340

Studies
Safety and Efficacy Study of Dose-escalated Hypofractionated Radiotherapy For Prostate Cancer

NCT01146340

Sponsor

Sunnybrook Health Sciences Centre

Status

Completed

Last Update Posted

Oct 4, 2019Actual

Enrollment

30Actual

Phase

Phase 1Phase 2

Conditions

Prostate Cancer

Interventions

Hypofractionated radiotherapy

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2010

Primary Completion Date

Apr 2016Actual

Completion Date

Apr 2016Actual

First Submitted Date

Jun 14, 2010

First Submission Date that Met QC Criteria

Jun 16, 2010

First Posted Date

Jun 17, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 2, 2019

Last Update Posted Date

Oct 4, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Andrew Loblaw, Radiation Oncologist, Sunnybrook Health Sciences CentrePrincipal Investigator

Lead Sponsor

Sunnybrook Health Sciences CentreOTHER

Collaborators

Name	Class
Canadian Association of Radiation Oncology	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine the safety and efficacy of a short course of radiotherapy (40 Gy / 5 fractions / 29 days) for the treatment of low- and intermediate-risk prostate cancer.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SBRT	Experimental	SBRT 40 Gy in 5 fractions over 29 days delivered using step and shoot IGRT	Radiation: Hypofractionated radiotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hypofractionated radiotherapy	Radiation	40 Gy / 5 fractions / 29 days	SBRT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of grade 3+ rectal toxicity	Common Terminology Criteria for Adverse Events (CTCAE) v3.0	Acute period (<3 months)

Secondary Outcomes

Measure	Description	Time Frame
Incidence of grade 3+ urinary toxicity	Common Terminology Criteria for Adverse Events (CTCAE) v3.0	Acute (<3 months) and Late (>6 months)
Quality of Life	Expanded Prostate Cancer Index Composite (EPIC)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Men >18 years
Histologically confirmed prostate adenocarcinoma
Low or low-intermediate risk prostate cancer, defined as Clinical stage T1-2b, Gleason Score <=6, and PSA <15 ng/mL, OR Clinical stage T1-2b, Gleason Score 7, and PSA <=10 ng/mL

Exclusion Criteria:

Prior pelvic radiotherapy
Anticoagulation medication (if unsafe to discontinue for gold seed insertion)
Diagnosis of bleeding diathesis
Presence of a hip prosthesis
Pelvic girth >40cm - Large prostate (>90cm3) on imaging
Severe lower urinary tract symptoms (International Prostate Symptom Score >19 or nocturia >3)

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Andrew Loblaw, MD	Sunnybrook Health Sciences Centre	Principal Investigator
Harvey Quon, MD	Sunnybrook Health Sciences Centre	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sunnybrook Health Sciences Centre		Toronto	Ontario	M4N 3M5	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27622157	Derived	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.

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

ID	Term
D019583	Dose Fractionation, Radiation
D011879	Radiotherapy Dosage
D011878	Radiotherapy
D013812	Therapeutics