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Intensity Modulated Versus Interstitial - Radiation Therapy

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ClinicalTrials.gov Identifier: NCT00407875
Recruitment Status : Suspended (Accrual has been very slow. We are currently determining whether or not to keep the trial going as is or to close the trial and write a new protocol.)
First Posted : December 5, 2006
Last Update Posted : October 15, 2009
Information provided by:
British Columbia Cancer Agency

Brief Summary:


The purpose of this trial is to compare two different treatment options for patients with low risk and low-tier intermediate risk prostate cancer. The two treatment arms being compared in this study are: (control arm) permanent interstitial prostate brachytherapy (PIPB) VERSUS (experimental arm) intensity modulated external beam radiation therapy (IMRT).


The acute and late toxicities experienced by patients in the experimental arm (IMRT) are not significantly worse then the toxicities experienced by patients in the control arm (PIPB).

Condition or disease Intervention/treatment Phase
Prostate Cancer Procedure: Intensity Modulated External Beam Radiation Therapy Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase II Study Comparing Intensity Modulated External Beam Radiation Therapy (IMRT) Versus Permanent Interstitial Prostate Brachytherapy (PIPB) for Low Risk and Low-tier Intermediate Risk Prostate Cancer
Study Start Date : March 2007
Estimated Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Primary Outcome Measures :
  1. The primary end point of this study is the acute and late toxicities of the therapeutic interventions.

Secondary Outcome Measures :
  1. The willingness of eligible patients to be randomized to the treatment interventions.
  2. Obstacles to accrual that need to be addressed.
  3. Testing our ability to meet accrual targets.
  4. Checking quality assurance benchmarks for IMRT and PIPB procedures.
  5. Discovering and relieving bottlenecks in IMRT planning and procedures.
  6. Quality of life.
  7. Pathological local control.
  8. Biochemical relapse-free survival.
  9. Metastasis-free survival.
  10. Overall survival.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients must have histologically proven adenocarcinoma of the prostate.
  2. Registration must occur within 20 weeks of biopsy.
  3. History and physical examination within 8 weeks prior to randomization.
  4. Patients must have either low risk or low-tier intermediate risk prostate cancer (Low risk must have all of: clinical stage <= T2b, Gleason score <= 6, and initial PSA <= 10; Low-tier intermediate risk must have: clinical stage <= T2c, < 50% positive biopsy cores, AND EITHER Gleason score = 7 and initial PSA <= 10 OR Gleason score <= 6 and initial PSA > 10 and <= 15.)
  5. Patients must have a ECG, PSA, TTT, CBC, electrolytes, Cr, INR, PTT, and random glucose within 2 weeks of registration.
  6. Patients must be fit for general or spinal anesthetic.
  7. Patients must have an estimated life expectancy of at least 10 years.
  8. Patients must have an ECOG performance status of 0 - 2.
  9. Patients must have no contraindications for high dose pelvic irradiation or transperineal interstitial brachytherapy.
  10. Patients must not have received prior radiation therapy to the pelvis.
  11. Patients must have no history of inflammatory bowel disease.
  12. Patients must not have received prior hormonal therapy or chemotherapy.
  13. Patients must not have any hormonal therapy planned as part of the therapeutic intervention.
  14. Patients must have prostate volumes < 60 cm3 on transrectal ultrasound.
  15. Patients must not have received prior surgical treatment for prostate cancer including TURP, TURB, cryotherapy, laser ablation or microwave therapy.
  16. Patients on coumadin therapy must be able to stop therapy safely for at least 12 days.
  17. Patients must have an International Prostate Symptom Score (IPSS) of less than 20.
  18. Patients must have no history of previous malignancies, except non-melanoma skin tumors.
  19. Patients must have a body mass index (BMI) of <= 32.

Exclusion Criteria:

Those patients who do not meet the inclusion criteria described above will be excluded from participation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00407875

Canada, British Columbia
BC Cancer Agency
Vancouver, British Columbia, Canada, V5Z 4E6
Sponsors and Collaborators
British Columbia Cancer Agency
Principal Investigator: William J Morris, MD British Columbia Cancer Agency

Responsible Party: Dr. William James Morris, British Columbia Cancer Agency - Vancouver Centre
ClinicalTrials.gov Identifier: NCT00407875     History of Changes
Other Study ID Numbers: IMVI-RT
First Posted: December 5, 2006    Key Record Dates
Last Update Posted: October 15, 2009
Last Verified: October 2009

Keywords provided by British Columbia Cancer Agency:

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases