Prostate Cancer
Conditions
Keywords
Brachytherapy, Quality of life, High dose rate vs. low dose rate, Intermediate risk group
Brief summary
H17-02904 is a randomized comparison of low dose rate vs. high dose rate prostate brachytherapy for favorable and intermediate risk prostate cancer suitable for brachytherapy as monotherapy. This is a continuation with expanded accrual of the randomized Pilot study H15-02103
Detailed description
Men suitable for prostate brachytherapy as monotherapy will undergo multiparametric Magnetic Resonance Imaging for staging and identification of a dominant lesion and will be randomly selected for either a single low dose rate permanent seed implant or 2 fractions of high dose rate brachytherapy. Using image registration techniques, dominant lesions will be biopsied under anesthesia at the start of the brachytherapy procedure. Biopsies will reviewed for tumor Gleason score and sent for Cell Cycle Progression testing (Prolaris). Patients receiving high dose rate brachytherapy will also have biopsies between the 2 fractions to assess tumor changes induced from the first fraction. Post implant quality assurance will determine the dose to the dominant lesions and compare these between the 2 types of brachytherapy. Post implant symptoms will be tracked for severity and time course.
Interventions
RADIATIONLow dose rate prostate brachytherapy
Permanent implantation of radioactive Iodine-125 seeds under anesthesia with ultrasound guidance
Temporary implantation of radioactive material into the prostate in the form of a stepping source of Iridium 192 that travels through 16-18 needles or catheters strategically placed through the prostate
Sponsors
British Columbia Cancer Agency
BC Cancer Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Favorable risk and low-tier intermediate-risk prostate cancer with estimated life expectancy of at least 10 years. * Clinical stage T1c-T2b, PSA \< 20, Gleason \< 8 * ECOG 0-1 * Low tier intermediate-risk prostate cancer is defined by a single NCCN intermediate risk factor * Extensive favorable-risk disease is defined as: * clinical stage T1c-T2a * PSA \< 10 * Gleason 6 * ≥ 50% of biopsy cores containing cancer * PSA density \> 0.2 ng/cc * Selected intermediate risk patients not defined above * \- T1c/T2a * \- PSA \< 10 * -Gleason 4+3 * PSA \> 10 and Gleason 3+4 * PSA 10-15 ng/ml and Gleason 4+3 * -\< 33% of cores involved * -Max tumor length in any core 10 mm * No androgen deprivation therapy (ADT) * Prostate volume by TRUS ≤ 60 cc. * Not eligible for, or accepting of, active surveillance according to NCCN guidelines. * Signed study specific informed consent.
Exclusion criteria
* Prior radical surgery for carcinoma of the prostate, * Prior pelvic radiation * Prior chemotherapy for prostate cancer, * Prior TURP or cryosurgery of the prostate * Claustrophobic or unable to undergo MRI
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The difference in Quality of Life in the urinary domain between LDR and HDR brachytherapy. | 0-60 months | The urinary domain of the EPIC prostate cancer specific QOL questionnaire will be assessed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life in the bowel and sexual domains | 0-60 months | The EPIC score in the bowel and sexual domains will be evaluated at baseline, 1, 3, 6, 12, 24, 36, 48 and 60 months |
| Time to return to baseline +/- 3 points for the International Prostate Symptom Score | 0-60 months | The IPS Score will be assessed at baseline, 1, 3, 6, 12, 24, 36, 48 and 60 months |
| Acute and long term toxicity | [Time Frame: 0-10 years] | Acute and long-term toxicity will be graded using the Common Terminology Criteria for Adverse Events (CTCAE V4) at each follow up time point |
| Biochemical Outcome | 5-10 years | PSA will be recorded every 6 months to 5 years and then annually to 10 years |
| Histologic Outcome | 3 years | Prostate re-biopsy will be performed at 36 months to assess the local efficacy of treatment |
| Cell cycle progression score | 1 month to 10 years | For those patients consenting to targeted biopsies under anesthesia at the start of their brachytherapy procedure (separate optional consent) MRI-TRUS fusion accuracy will be verified by targeted biopsies and Biopsy material will be sent for genetic testing to determine Cell cycle Progression scores for both arms of the trial to ultimately correlate with outcome. |
| Tumor oxygenation and cell cycle distribution | 1 month to 10 years. | For patients receiving 2 fractions of high dose rate brachytherapy, biopsy between the 2 fractions will assess radiosensitivity by evaluating changes in oxygenation and cell cycle distribution between the 2 fractions, for ultimate correlation with efficacy |
Countries
Canada
Contacts
STUDY_DIRECTORRoss Halperin, MD
British Columbia Cancer Agency Program Director
Outcome results
None listed