Prostate Cancer Clinical Trial
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
Verified date | July 2018 |
Source | British Columbia Cancer Agency |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Active, not recruiting |
Enrollment | 50 |
Est. completion date | March 2020 |
Est. primary completion date | March 2008 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | N/A and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Canada | BC Cancer Agency | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
British Columbia Cancer Agency |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary end point of this study is the acute and late toxicities of the therapeutic interventions. | Through study completion. Approximately 5 years. | ||
Secondary | The willingness of eligible patients to be randomized to the treatment interventions. | 1 year | ||
Secondary | Obstacles to accrual that need to be addressed. | 1 year | ||
Secondary | Testing our ability to meet accrual targets. | 1 year | ||
Secondary | Checking quality assurance benchmarks for IMRT and PIPB procedures. | 1 year | ||
Secondary | Quality of life based on urinary function, bowel habits, sexual function, and hormonal function | Assessed at 6 weeks, 6, 9, 12, 18, 24 ,30, 36 months. Then annually until end of participation | ||
Secondary | Pathological local control. | Assessed at 28 months | ||
Secondary | Biochemical relapse-free survival. | Assessed at every clinic visit and every 6 months | ||
Secondary | Metastasis-free survival. | Assessed at every clinic visit until end of participation. Approximately 10 years. | ||
Secondary | Overall survival. | Assessed at every clinic visit until end of participation. Approximately 10 years. |
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