Stereotactic Pelvic Brachytherapy With HDR Boost for Dose Escalation in High Tier Intermediate and High Risk Prostate ca
NCT ID: NCT04236752
Last Updated: 2020-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
33 participants
INTERVENTIONAL
2014-09-29
2020-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Utilizing multiparametric MRI to focally boost the dominant intraprostatic lesion during HDR brachytherapy is safe and feasible.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Focal Versus Whole Gland High Dose-Rate Brachytherapy (HDR-BT) Boost to External Beam Radiotherapy in Localized Prostate Cancer: A Phase 2 Randomized Trial
NCT07300566
MRI Assisted Focal Boost With HDR Monotherapy for Prostate Cancer Patients
NCT02623933
High Dose Rate Prostate Brachytherapy: Dose Escalation to Dominant Intra-prostatic Nodule
NCT01605097
Focal HDR Brachytherapy Boost to Stereotactic Radiotherapy
NCT04100174
Combined LDR Boost and HDR Whole Gland
NCT03323879
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Single arm radiotherapy
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
Stereotactic Ablative Body Radiation (SBRT)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Stereotactic Ablative Body Radiation (SBRT)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Men \>18 years
* Histologically confirmed prostate adenocarcinoma (centrally reviewed)
* High tier intermediate risk defined as :
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
* Prior pelvic radiotherapy
* Anticoagulation medication (if unsafe to discontinue for gold seed insertion)
* Diagnosis of bleeding diathesis
* Large prostate (\>50cm3) on imaging
* No evidence of castrate resistance (defined as PSA \< 3 ng/ml while testosterone is \< 0.7 nmol/l. Patients could have been on combined androgen blockade but are excluded if this was started due to PSA progression.
* Definitive regional or distant metastatic disease on staging investigations.
18 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Prostate Cancer Canada
OTHER
Sunnybrook Health Sciences Centre
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Sunnybrook Health Sciences Center
Toronto, Ontairo, Canada
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SPARE
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.