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

NCT02107287 | Completed

• 1 other identifier: 11-519 GEN
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

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

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 Technique RADIATION

IMRT Hypofractionated

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (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
• 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

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.

Sponsors & Collaborators

• Sergio Faria: lead

Study Sites (1)

McGill University Health Center

Montreal, Quebec, H3G 1A4, Canada

Location

Study Officials

• Sergio Faria, M.D.

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

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 1, 2011
• Primary Completion: April 1, 2016
• Study Completion: June 1, 2016
• Last Updated: September 27, 2016

Record last verified: 2016-09

Locations

CA (1)