Status:
UNKNOWN
Intensity Modulated Versus Interstitial - Radiation Therapy
Lead Sponsor:
British Columbia Cancer Agency
Conditions:
Prostate Cancer
Eligibility:
MALE
Phase:
NA
Brief Summary
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 th...
Detailed Description
Justification: Patients with low risk and low-tier intermediate risk prostate cancer have a number of different standard treatment options to chose from that include a radical prostatectomy, conventi...
Eligibility Criteria
Inclusion
- Patients must have histologically proven adenocarcinoma of the prostate.
- Registration must occur within 20 weeks of biopsy.
- History and physical examination within 8 weeks prior to randomization.
- 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.)
- Patients must have a ECG, PSA, TTT, CBC, electrolytes, Cr, INR, PTT, and random glucose within 2 weeks of registration.
- Patients must be fit for general or spinal anesthetic.
- Patients must have an estimated life expectancy of at least 10 years.
- Patients must have an ECOG performance status of 0 - 2.
- Patients must have no contraindications for high dose pelvic irradiation or transperineal interstitial brachytherapy.
- Patients must not have received prior radiation therapy to the pelvis.
- Patients must have no history of inflammatory bowel disease.
- Patients must not have received prior hormonal therapy or chemotherapy.
- Patients must not have any hormonal therapy planned as part of the therapeutic intervention.
- Patients must have prostate volumes \< 60 cm3 on transrectal ultrasound.
- Patients must not have received prior surgical treatment for prostate cancer including TURP, TURB, cryotherapy, laser ablation or microwave therapy.
- Patients on coumadin therapy must be able to stop therapy safely for at least 12 days.
- Patients must have an International Prostate Symptom Score (IPSS) of less than 20.
- Patients must have no history of previous malignancies, except non-melanoma skin tumors.
- Patients must have a body mass index (BMI) of \<= 32.
Exclusion
- Those patients who do not meet the inclusion criteria described above will be excluded from participation.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2020
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00407875
Start Date
March 1 2007
End Date
March 1 2020
Last Update
July 13 2018
Active Locations (1)
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1
BC Cancer Agency
Vancouver, British Columbia, Canada, V5Z 4E6