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Completed

NCT Number: NCT02107287

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

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.

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Key information

Conditions

High Risk Prostate Cancer

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

McGill University Health Center

Montreal, Quebec, H3G 1A4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

IMRT Technique

Radiation

Primary outcomes

  1. Toxicity

    Time frame: First 3 months (acute 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.

Secondary outcomes

  1. Freedom from biochemical failure, patterns of failure.

    Time frame: At 5 years

    To measure freedom from biochemical failure (PSA measurement) at 5 years.

Other outcomes

  1. Toxicity

    Time frame: 3 years

    Late effects will be also scored prospectively using the RTOG/EORTC late scoring system. Erectile dysfunction will be assessed by the SHIM questionnaire

  2. Toxicity

    Time frame: 3 years

    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. Rate of failure

    Time frame: 5 years

    To determine the rate of local, regional and distant failures.

  4. Quality Assurance

    Time frame: 5 years

    To develop a quality assurance process for IMRT in prostate cancer at McGill University Health Center

Sponsors and collaborators

Lead sponsor

Sergio Faria

Other

Registry information

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Apr 8, 2014
Registry last updated
Sep 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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