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NCT Number: NCT00188513

Intensity Modulated Radiation Therapy - Prostate Cancer

There are several different treatment schedules being used across the world for treatment of prostate cancer with radiation therapy. In order to determine the best radiation treatment for this disease, a study is being performed by the doctors at the Princess Margaret Hospital. This study will try to measure the effectiveness and side effects of an increased dose of radiation to the prostate that is also given over a shorter number of weeks than is usually done. In order to try to reduce the possible side effects of the radiation therapy the treatment will be given using special techniques to shield as much of your normal body tissues as possible. This method of treatment is called conformal intensity modulated radiation therapy, or IMRT.

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Key information

Conditions

Prostatic Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Histologic diagnosis of adenocarcinoma of the prostate within six months of entry
  • Clinical stage T1B, T1C, T2A-C NX MO (see Appendix 1 for staging). Any Gleason score is eligible for entry, but Gleason score must be determined.
  • Patients with a PSA >10.0 and Gleason score of 7; or patients with any PSA value and Gleason score of >8 must have clinically negative lymph nodes as determined by a pelvic CT scan done within 12 weeks of entry. A negative bone scan is required before entry for all patients with Gleason score >8, or any patient with a Gleason score of 7, and a PSA >10.
  • The patient must not have received any cytotoxic anticancer therapy. Previous or concurrent hormonal therapy for local disease is acceptable.
  • ECOG performance status of 1 or less
  • Age 80 years old or less
  • Serum PSA <25 ng/ml within 4 weeks of study entry
  • Informed consent

Exclusion criteria

  • Patients with history of inflammatory bowel disease or other contraindication to radical radiation therapy
  • Patients with prior colorectal surgery
  • Any prior pelvic radiotherapy. Any prior TURP done <12 weeks from study entry.
  • Any previous cytotoxic chemotherapy
  • Patients with prior malignancy except non-melanoma skin carcinoma within 5 years of the diagnosis of prostate cancer

Treatment and study plan

conformal intensity modulated radiotherapy (IMRT)

Procedure

Primary outcomes

  1. To determine feasibility and late toxicity of administering 66 Gy in 22 fractions over 4.5 weeks (using conformal IMRT treatment techniques) to the prostate and adjacent tissues in patients with localized prostate ca

    Time frame: at each post treatment follow-up for up to 3 years

Secondary outcomes

  1. To evaluate acute toxicity of therapy

    Time frame: weekly during RT

  2. To evaluate local control as assessed by prostate biopsy at 2.5 years

    Time frame: 2.5 years

  3. To evaluate time to disease progression

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • Princess Margaret Hospital, Canada

Registry information

Official study title

A Phase I-II Prospective Trial of Conformal Hypofractionated Intensity Modulated Radiotherapy (IMRT) for Localized Adenocarcinoma of the Prostate

Important dates

Study start
2001
Primary completion
2006
Study completion
2017
First posted
Sep 16, 2005
Registry last updated
Jun 12, 2018

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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