HDR Focal: Feasibility Study
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|ClinicalTrials.gov Identifier: NCT02918253|
Recruitment Status : Recruiting
First Posted : September 28, 2016
Last Update Posted : April 13, 2021
Brachytherapy as a monotherapy treatment is highly effective for localized prostate cancer, traditionally being delivered to the whole prostate gland. Lately, low dose rate (LDR) brachytherapy has been increasingly replaced by high dose rate (HDR) brachytherapy treatment schemes. While brachytherapy's oncologic outcomes are excellent, it is not without incidence adverse effects including urinary, rectal, and sexual toxicities that affect the patient's quality of life.
This study will incorporate HDR monotherapy treatment option for early stages and favourable risk prostate cancer.
Additionally, we aim to evaluate the role of focal HDR brachytherapy for well-defined disease based on multiparametric MRI (mpMRI). This approach may offer an option of reducing the treatment toxicities while maintaining oncologic outcomes when compared with whole-gland therapy. Advantages in quality of life could be exhibited in the form of reduced urinary discomfort and incontinence, rectal symptoms, and improved erectile and prostatic gland function. This study would be particularly relevant in the current era of earlier localized prostate cancer detection, where newer imaging modalities (e.g. mpMRI) become a routine component of patient care.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Radiation: targeted focal HDR brachytherapy Radiation: Whole-gland HDR Brachytherapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||HDR Monotherapy for Prostate Cancer: A Feasibility Study of Focal Radiotherapy Yields|
|Actual Study Start Date :||October 14, 2016|
|Estimated Primary Completion Date :||November 2023|
|Estimated Study Completion Date :||December 2023|
Experimental: Tumour visible on MRI
Targeted focal HDR Brachytherapy to dominant lesion +/- whole-gland elective dose
Radiation: targeted focal HDR brachytherapy
Active Comparator: No tumour visible on MRI
Whole-gland HDR Brachytherapy
Radiation: Whole-gland HDR Brachytherapy
Control/Standard of Care
- number of patients achieving biochemical control [ Time Frame: 2 yrs ]
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): NCT02918253
|Contact: Alejandro Berlin, MDfirstname.lastname@example.org|
|Princess Margaret Cancer Centre||Recruiting|
|Toronto, Ontario, Canada, M5G 2M9|
|Principal Investigator: Alejandro Berlin, MD|