Intensity Modulated Versus Interstitial - Radiation Therapy

This study has suspended participant recruitment.
(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.)
Sponsor:
Information provided by:
British Columbia Cancer Agency
ClinicalTrials.gov Identifier:
NCT00407875
First received: December 1, 2006
Last updated: October 14, 2009
Last verified: October 2009
  Purpose

Purpose:

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).

Hypothesis:

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 Intervention Phase
Prostate Cancer
Procedure: Intensity Modulated External Beam Radiation Therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by British Columbia Cancer Agency:

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

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

Estimated Enrollment: 50
Study Start Date: March 2007
Estimated Study Completion Date: November 2016
  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00407875

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

No publications provided

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
Study First Received: December 1, 2006
Last Updated: October 14, 2009
Health Authority: Canada: Health Canada

Keywords provided by British Columbia Cancer Agency:
Prostate
Cancer
Radiation

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

ClinicalTrials.gov processed this record on September 16, 2014