NCT02107287

Completed

Hypofractionated Intensity Modulated Radiation Therapy Plus ...

Sergio Faria Source

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Other study identifiers

Sponsor study identifier

11-519 GEN

Study Type

interventional

Actual enrollment (reported)

105

Locations

1 country

Sites

1

Timeline

Study Start

August 2011

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

April 2016

Actual (reported)

Study Completion

June 2016

Actual (reported)

Brief Summary

Considering the promising results with hypofractionated in low and intermediate risk prostate cancer, our proposal is to translate this experience to patients with high risk prostate cancer. Patients with high risk disease would receive hypofractionated RT to the prostate and to the external and internal iliac lymph nodes using IMRT plus long-term hormonal therapy. The objective of the study is to show that long term grade\>2 late toxicity is acceptable and similar to published data using hypofractionated technique in the prostate only.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 105 participants
Study completion date: June 2016
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
August 2011
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
August 22, 2012
Actual (reported)
First Posted
April 8, 2014
Actual (reported)
Primary Completion
April 2016
Actual (reported)
Study Completion
June 2016
Actual (reported)

Last Updated: September 27, 2016
Status Verified: September 2016
Last Update Submitted: September 26, 2016

Conditions

High Risk Prostate Cancer

Outcome Measures

Primary Outcomes (1)

Toxicity
Acute and late toxicity following treatment with IMRT to the prostate and pelvic lymphatic chains will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (http://ctep.cancer.gov) for grading of all adverse events will be used in this study.
First 3 months (acute toxicity)

Secondary Outcomes (1)

Freedom from biochemical failure, patterns of failure.
At 5 years

Other Outcomes (4)

Toxicity
3 years
Toxicity
3 years
Rate of failure
5 years
+1 more other outcomes

Study Arms (1)

IMRT Hypofractionated

EXPERIMENTAL

Neo-adjuvant hormone therapy for three months followed by IMRT combined with a 24-month hormonal therapy.

Radiation: IMRT Technique

Interventions

IMRT TechniqueRadiation

IMRT Hypofractionated

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexmale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

pathologically proven diagnosis of adenocarcinoma of the prostate meeting one of the following conditions:
Clinical Stage \>T3 or

Sponsors & Collaborators

Sergio Faria
Otherlead

Study Sites (1)

McGill University Health Center

Montreal, Quebec, H3G 1A4, Canada

Study Officials

Sergio Faria, M.D.
McGill University Health Centre/Research Institute of the McGill University Health Centre
PRINCIPAL INVESTIGATOR

Enrollment

105 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR INVESTIGATOR
PI Title: Associate Professor. Oncology.

Study Record Dates

First Submitted

August 22, 2012

First Posted

April 8, 2014

Study Start

August 2011

Date type not reported

This date has not been verified as actual or estimated.

NCT01695473

Neoadjuvant BKM120 in High-risk Prostate Cancer

Phase 2Terminated

NCT07208240

Tb-PSMA-I&T Radionuclide Before Radical Prostatectomy in Patients With Locally Advanced Prostate Cancer - TbeforePROST Trial.

Phase 1/2Recruiting

NCT06949254

PRospective Observational Study of STereotactic Body rAdiation Therapy With Androgen Deprivation Therapy for Organ-confined High-risk Prostate Cancer: the PROSTAR Trial

Recruiting

NCT01702610

Phase II Trial of Neo-adjuvant Temozolomide Prior to Combined Temozolomide and Concurrent Accelerated Hypofractionated External Beam Radiotherapy Followed by Adjuvant Temozolomide in Patients With Newly Diagnosed Glioblastoma Multiforme

Not ApplicableCompleted

NCT03340272

PROspective Multicenter Observational Study on Elective Pelvic Nodes Irradiation.

Unknown

NCT06758882

Surgical Treatment With or Without Apalutamide in Subjects With High Risk Prostate Cancer Who Are Candidates for Radical Prostatectomy and Staged as Oligometastatic With PSMA-PET

Phase 2Recruiting

Gleason Score 8 or higher, or

PSA level \>20ng/ml

Study entry PSA must be obtained within 6 weeks prior to protocol entry

ECOG \<2

Age \>18

History and physical examination within 3 months

Bone scan and CT scan of the abdomen and pelvis within 3 months with no evidence of bone metastases and no pelvic lymph nodes larger than 1.0cm, unless biopsy negative.

CBC with differential within 6 weeks prior to protocol entry

Absolute neutrophil count \>2000cells/mm3

Hemoglobin \>8.0 g/dl (the use of transfusion to increase the Hg is acceptable)

Testosterone level within 6 weeks of protocol entry

Liver function tests

Signed informed consent

+1 more criteria

You may not qualify if:

Prior use of hormonal therapy for prostate cancer for more than 2 months. Previous use of finasteride or dutasteride is allowed.
Prior invasive malignancy (except non-melanoma skin) unless disease-free for more than 5 years.
Prior radiotherapy to the pelvis
Life expectancy of less than 2 years.

Contact the study team to confirm eligibility.

Primary Completion

April 2016

Actual (reported)

Study Completion

June 2016

Actual (reported)

Last Updated

September 27, 2016

Record last verified: 2016-09

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT02107287
Data provider: ClinicalTrials.gov
Source updated: 2016-09-27
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:37:04 UTC

Locations

CA(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Other Outcomes (4)

Study Arms (1)

IMRT Hypofractionated

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations