An interventional study of Stereotactic Ablative Body Radiation (SBRT) in HIGH RISK PROSTATE CANCER, sponsored by Sunnybrook Health Sciences Centre. Status unknown at 1 site in Canada. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-22.
Sponsored by Sunnybrook Health Sciences Centre · Not applicable, Interventional, and Treatment
HDR brachytherapy in conjunction with pelvic SABR in high tier intermediate and high risk prostate cancer patients can provide a safe and effective means of radiotherapy dose escalation.
Utilizing multiparametric MRI to focally boost the dominant intraprostatic lesion during HDR brachytherapy is safe and feasible.
HDR brachytherapy:
Under general anesthetic, prostate will be implanted transperineally using up to 18 catheters. Three gold seed fudicials will also be implanted transperineally at base, midgland and apex forSABR treatment. Prostate will be contoured as Clinical Target Volume (CTV) on the transrectal ultrasound (TRUS) based ONCENTRA planning system. Rectum and urethra will be contoured as organs at risk. 15Gy will be prescribed to CTV as the MPD (minimal Peripheral Dose).
Treatment Delivery-SABR There will be a 2 week interval between HDR and SABR component to allow for normal tissue recovery and radiotherapy planning time. Daily image guidance will be performed using the implanted fiducials to calculate patient shifts to ensure proper positioning. Post-treatment images will be taken to estimate intrafraction motion.
Androgen Deprivation Therapy Twelve to 18 months of luteinizing-hormone releasing hormone agonists (LHRHa) will be used. Anti-androgen and neoadjuvant LHRHa can be used according to physician discretion
Follow-Up and Toxicity Assessment Time zero will be the start of radiotherapy. Baseline rectal and urinary function will be recorded using common toxicity criteria adverse effect (CTCAE v3.0) and Expanded prostate Cancer Index Composite (EPIC). CTCAE v3.0 and EPIC assessments will be done at weeks 3, 5 and 12 weeks. Bloodwork (PSA and testosterone), quality of life (EPIC) and late GI and GU toxicity evaluation (using the RTOG/EORTC Late Radiation Morbidity Scheme) will be performed every 6 months for the first 5 years.
6,367 studies on the registry are indexed under Prostatic Neoplasms; 1,397 are open to participants now.
This study's enrollment of 33 is below the median of 58 across 4,821 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Sunnybrook Health Sciences Centre is the lead sponsor of 566 studies on the registry; 134 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Clinical stage T1-T2c AND PSA 10-20ng/ml AND {PSA>10ng/ml AND (T2b-2c Or Gleason 7)} OR Gleason 4+3
-High-risk prostate cancer, defined as at least one of: Clinical stage T3, OR Gl 8-10, OR PSA > 20 ng/mL
Inclusion Criteria:
HDR Brachytherapy Boost of 15Gy to the prostate followed by Stereotactic Ablative Body Radiation (SBRT) 25 Gy in 5 fractions, once weekly to prostate, SVs and pelvic lymph nodes + 6-18 months of ADT
Radiation: Stereotactic Ablative Body Radiation (SBRT)
Acute GI and GU toxicities
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v3.0, Change From Baseline in Pain Scores on the Visual Analog Scale at 6 Weeks. This will be calculated using the F distribution method (exact confidence limits).
Time frame: Baseline (start of treatment) to 6 weeks post completion of Radiation treatment
Late GI and GU RTOG toxicities
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v3.0, Change From 6 months post treatment to end of 5 year follow up. This will be calculated using the F distribution method (exact confidence limits).
Time frame: 6 months post start of treatment to end of 5 year follow up post completion of treatment
Quality of Life outcome- EPIC
Quality of life using the Expanded Prostate Cancer Index Composite (EPIC) questionnaire.
Time frame: Baseline ( start of treatment) to end of 5 year follow up post completion of treatment
Biochemical disease-free survival
Biochemical disease-free survival post treatment
Time frame: Baseline ( start of treatment) to end of 5 year follow up post completion of treatment
Quality of Life outcome- EQ5D
Assess the impact of modifiable life style factors on radiation toxicity as well as Determine the health preference values using the EQ5D(EQ-5D is the name of the instrument and is not an acronym.)
Time frame: Baseline to end of 5 year follow up post completion of treatment
Quality of Life outcome- PORPUS-U
Assess the impact of modifiable life style factors on radiation toxicity as well as Determine the health preference values using the PORPUS -U(PORPUS-U is the name of the instrument and is not an acronym.)
Time frame: Baseline ( start of treatment) to end of 5 year follow up post completion of treatment
Plan to share: No — Overall study data will be available thru publications. Individual Participants Data will not be made public.
No publications or documents are linked to this record.
This study is status unknown, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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Sunnybrook Health Sciences Centre