Salvage Prostatectomy After Radiotherapy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00791115|
Recruitment Status : Active, not recruiting
First Posted : November 14, 2008
Last Update Posted : August 19, 2020
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Procedure: whole-mount sectioning of the prostate||Not Applicable|
Two hundred and nineteen thousand new cases of prostate cancer have been projected in the Unites States for 2007, with external beam radiotherapy (EBRT) constituting the mainstay of local therapy for an increasing proportion of newly diagnosed patients. Despite improvements in the delivery and reduction in associated toxicity of external beam radiotherapy, local persistence or recurrence of disease remains prevalent in 25-51% of patients. Local disease after EBRT is a risk factor for subsequent metastatic progression and prostate cancer-specific mortality, and is a cause of morbidity including hematuria, obstructive uropathy, and chronic pain. Given its prevalence, and the lack of satisfactory local salvage treatments, fear of prostate cancer recurrence has been shown to impose a substantial burden of suffering in patients.
Stereotactic needle placement under MRI-guidance enables two critical steps in tumor-targeted brachytherapy: 1) directly guiding brachytherapy catheters to sites of tumor recurrence, and 2) permitting treatment planning and delivery to be based on 3D MRI images. MRI-based HDR brachytherapy will precisely identify the location of brachytherapy catheters relative to the target volumes and adjacent normal structures at risk of radiation injury, obviating the need for invasive saturation (24-100) mapping biopsies.
This study will build the evidence supporting the concept of tumor-targeted salvage HDR brachytherapy, by providing further histopathological validation of the method.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Salvage Prostatectomy After Radiotherapy: Whole-Mount Histopathological Validation for Tumor-Targeted Salvage HDR Brachytherapy|
|Study Start Date :||June 2008|
|Estimated Primary Completion Date :||June 2022|
|Estimated Study Completion Date :||June 2022|
|Experimental: prostatectomy after radiotherapy||
Procedure: whole-mount sectioning of the prostate
A standard open retropubic radical prostatectomy will be performed. Whole fresh prostate is be embedded in gel and oriented in the anatomic position in a plastic cylinder using wood skewers. Standard pathology reports are generated from this tissue
- To Validate virtual dosimetry plans for tumor-targeted salvage (High-Dose-Rate) HDR brachytherapy against co-registered whole-mount prostatectomy specimens. [ Time Frame: Patients will have follow-up assessments at 1,3 and 6 months and 1,2,3 and 5 years after surgery. ]
- Preliminary evaluation of surgical margin status, toxicity and QOL, and biochemical control after salvage RP. [ Time Frame: Patients will have follow-up assessments at 1,3 and 6 months and 1,2,3 and 5 years after surgery. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00791115
|University Health Network|
|Toronto, Ontario, Canada, M5G 2M9|
|Principal Investigator:||Cynthia Ménard, MD||University Health Network, Toronto|