Optimizing Prostate Cancer Treatment in Men With Advanced Local Disease (OPTiMAL)
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|ClinicalTrials.gov Identifier: NCT03836196|
Recruitment Status : Not yet recruiting
First Posted : February 11, 2019
Last Update Posted : February 11, 2019
Multi-modality therapy that includes a brachytherapy implant improves outcomes in locally advanced prostate cancer when compared to other radiation-based treatments, but is also associated with more adverse side effects. The goal of the OPTiMAL trial is to reduce these side effects by using advanced imaging and biopsy techniques to locate cancer and deliver precision radiation therapy, while not compromising the unprecedented high cure rates obtained for the brachytherapy arm of the Androgen Suppression Combined with Elective Nodal and Dose Escalated Radiation Therapy (ASCENDE-RT) randomized control trial.
Additionally, some applied research in genetics, pathology and medical imaging is included. Novel medical imaging methods, namely, multi-parametric magnetic resonance imaging (MRI), multi-parametric trans-rectal ultrasound (TRUS), prostate-specific membrane antigen (PSMA) positron emission tomography/computed tomography (PET/CT) are used for re-staging of prostate cancer. This is followed by trans-perineal biopsy to locate cancerous areas of the prostate with greater precision compared to conventional biopsy. Results from imaging are compared to those from biopsy to develop image-based cancer detection methods.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Radiation: LDR Brachytherapy and External Beam Radiation Therapy||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||105 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Optimizing the Management of High-risk and Unfavorable Intermediate-risk Disease: the Use of Advanced Imaging, Trans-perineal Mapping Biopsies, and Dual-strength Brachytherapy Sources to Minimize Radiation Dose to Normal Tissues|
|Estimated Study Start Date :||February 2019|
|Estimated Primary Completion Date :||February 2025|
|Estimated Study Completion Date :||February 2028|
Experimental: Combined radiation treatment
Combined low-dose-rate brachytherapy and external beam radiation therapy
Radiation: LDR Brachytherapy and External Beam Radiation Therapy
Low Dose Rate Brachytherapy (LDR-PB) and External Beam Radiation Therapy (EBRT)
- Frequency of treatment-related GU adverse effects [ Time Frame: Analysis to be done at median follow-up of 2 years ]Cumulative frequency of Physician-reported grade 2 and above GU adverse events (scored using a modified CTCAE - Common Terminology Criteria for Adverse Events- scale).
- Trans-perineal biopsy and imaging correlation [ Time Frame: 2 years ]Correlations between trans-perineal biopsy and multi-modality, multi-parametric imaging provided by multi-parametric TRUS, multi-parametric MRI and PSMA PET/CT
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): NCT03836196
|Contact: Michael Peacock, MDfirstname.lastname@example.org|
|Principal Investigator:||Michael Peacock, MD||BCCANCER|