HDR Focal: Feasibility Study

Prostate Cancer Clinical Trial

Official title:

HDR Monotherapy for Prostate Cancer: A Feasibility Study of Focal Radiotherapy Yields

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02918253
• Other study ID #: 16-5490
• Status: Recruiting
• Phase: N/A
• Start date: October 14, 2016
• Est. completion date: December 2024

Study information

• Verified date: December 2023
• Source: University Health Network, Toronto
• Contact: Alejandro Berlin, MD
• Email: alejandro.berlin[@]rmp.uhn.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years
• ECOG performance status 0 - 2
• Histological evidence of prostate adenocarcinoma
• Low- and favorable intermediate-risk prostate cancer
• Informed consent: All patients must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed
• No contraindications to MRI:
• Absent or unifocal intraprostatic disease (<2 separate/distinct lesions), on multiparametric MRI
• Prostate gland size <80cc
• Baseline IPSS <18
• No TRUP within the past 6 months, nor large TURP defect
• Absence of radiological evidence of regional or distant metastases (optional evaluation, at physician discretion)
• No previous pelvic and/or prostate EBRT and/or brachytherapy
• No contraindications to general anesthesia, or spinal/epidural anesthesia
• Absence of bleeding diathesis and/or anti-coagulative therapy that cannot be temporarily ceased during brachytherapy
• No contraindications to endorectal coil, surgically absent rectum, severe hemorrhoids or colorectal surgery
• Negative past medical history of Ulcerative Colitis, Crohn's Disease, Ataxia Telangiectasia, or SLE
• Absence of latex allergy
• No other medical conditions deemed by the PI to make patient ineligible for prostate HDR brachytherapy

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• targeted focal HDR brachytherapy

• Whole-gland HDR Brachytherapy
Control/Standard of Care

Locations

Country	Name	City	State
Canada	Princess Margaret Cancer Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of patients achieving biochemical control		2 yrs