Hypofractionated Intensity Modulated Radiation Therapy Plus Hormonal Therapy in Patients With High Risk Prostate Cancer

High Risk Prostate Cancer Clinical Trial

Official title:

Hypofractionated Intensity Modulated Radiation Therapy Plus Hormonal Therapy in Patients With High Risk Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02107287
• Other study ID #: 11-519 GEN
• Status: Completed
• Phase: N/A
• First received: August 22, 2012
• Last updated: September 26, 2016
• Start date: August 2011
• Est. completion date: June 2016

Study information

• Verified date: September 2016
• Source: McGill University Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: June 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• pathologically proven diagnosis of adenocarcinoma of the prostate meeting one of the following conditions:

• Clinical Stage >T3 or

• 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

• Prior use of hormonal therapy for prostate cancer is acceptable if less than 2 months.

Exclusion Criteria:

• 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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• High Risk Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• IMRT Technique

Locations

Country	Name	City	State
Canada	McGill University Health Center	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Sergio Faria

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Toxicity	Late effects will be also scored prospectively using the RTOG/EORTC late scoring system. Erectile dysfunction will be assessed by the SHIM questionnaire	3 years	Yes
Other	Toxicity	Dose-volume histogram of the rectum and bladder will be correlated to the whole organ volumes doses and the development of GI and GU toxicity.	3 years	Yes
Other	Rate of failure	To determine the rate of local, regional and distant failures.	5 years	No
Other	Quality Assurance	To develop a quality assurance process for IMRT in prostate cancer at McGill University Health Center	5 years	Yes
Primary	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)	Yes
Secondary	Freedom from biochemical failure, patterns of failure.	To measure freedom from biochemical failure (PSA measurement) at 5 years.	At 5 years	Yes