SBRT vs. Conventional Fractionation With HDR Boost for Prostate Cancer (SHARP)

A Randomized Feasibility Trial of Stereotactic Body Radiotherapy Versus Conventional Fractionation With High Dose-rate (HDR) Brachytherapy Boost for Prostate Cancer

Random assignment between SBRT and conventionally fractionated boost following HDR brachytherapy for prostate cancer.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Radiation: Conventionally Fractionated Radiation; Radiation: Sterotactic Body Radiotherapy

Detailed Description

Many treatment options exist for prostate cancer. One common treatment approach is to combine high-dose rate (HDR) brachytherapy (temporary insertion of radiation into the prostate) and external beam radiation. External beam radiation typically requires daily radiation treatment for three to five weeks. Improvements to radiation planning and delivery has allowed stereotactic body radiation therapy (SBRT) to be implemented in many types of cancer. SBRT has been implemented as a standard treatment option after HDR brachytherapy in response to the COVID pandemic. We are seeking to evaluate whether it is feasible to randomly assign men between SBRT (which will be five treatments of radiation or conventional radiation (3-5 weeks of daily treatment) following HDR brachytherapy

• Study Type: Interventional
• Enrollment (Anticipated): 55
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gerard Morton, MD; Phone Number: 6165 416-480-6100; Email: gerard.morton@sunnybrook.ca
• Study Contact Backup: Name: Merrylee McGuffin; Phone Number: 85454 416-480-6100; Email: Merrylee.Mcguffin@sunnybrook.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Recruiting
      • Sunnybrook Health Sciences Centre
      • Contact: Gerard Morton, MD, FRCPC; Phone Number: 6165 416-480-6100
      • Contact: Merrylee McGuffin, MSc, MRT(T); Phone Number: 85454 416-480-6100; Email: Merrylee.Mcguffin@sunnybrook.ca
      • Principal Investigator: Mark Corkum

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18 or older
• Informed consent for treatment and study participation completed
• Pathologically proven diagnosis of prostate adenocarcinoma
• ECOG Performance Status 0-2
• No prior history of pelvic radiotherapy, brachytherapy, cryosurgery, HIFU, TURP or radical prostatectomy

Exclusion Criteria:

• Presence of nodal or distant metastasis on staging MRI or CT Abdomen/Pelvis and Bone scan within 90 days of enrolment (CT/MRI/Bone Scan are only required if the clinical risk of metastatic disease is sufficient to warrant these scans)
• Plan for adjuvant chemotherapy post-radiotherapy
• Serious medical comorbidities or other contraindications to HDR brachytherapy
• Presence of inflammatory bowel disease
• Presence of connective tissue disorder seen as a contraindication to radiotherapy
• Medically unfit for general/spinal anesthesia
• Unable or unwilling to complete questionnaires

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional Fractionated Radiation; Prostate Only Radiation - 37.5Gy in 15 daily fractions to the prostate and proximal/entire seminal vesicle; Prostate + Nodal Radiation - 46Gy in 23 daily fractions to the prostate, seminal vesicle and regional lymph nodes	Radiation: Conventionally Fractionated Radiation; External beam radiation therapy treatment
Experimental: Stereotactic Body Radiotherapy; Prostate Only Radiation - 25Gy in 5 fractions to the prostate and proximal/entire seminal vesicle; Prostate + Nodal Radiation - 25Gy in 5 fractions to the prostate, seminal vesicle and regional lymph nodes	Radiation: Sterotactic Body Radiotherapy; Hypofractionated stereotactic radiation treatment.; Other Names: SBRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Feasibility	The proportion of patients accepting of being randomized divided by the number of patients approached for the study.	18mo - 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
QOL	Urinary, bowel and sexual health-related quality of life measured by the Expanded Prostate Cancer Index Composite (EPIC) domains over the study period. Each domain is normalized from 0 to 100, with a higher score indicating better outcome.	7 years
Treatment Toxicity	Proportion of patients with urinary, bowel and sexual Grade 2 and 3 toxicity measured by CTCAE v5.0 throughout the study period.	7 years
Cumulative biochemical failure	Defined as the time of enrolment to biochemical failure (based on the Phoenix definition, PSA nadir plus 2)	7 years
Overall Survival	Defined as time of enrollment to death from any cause	7 years
Cancer Free Survival	Defined as time of enrolment to death attributed to prostate cancer	7 years
Metastasis Free Survival	Defined as time of enrolment to development of metastasis or death from any cause	7 years
Freedom From Local Failure	Defined as time of enrolment to first local recurrence	7 years
Freedom From Regional Failure	Defined as time of enrolment to first regional recurrence	7 years
ADT Free Survival	Defined as time of enrolment to salvage ADT use or death from any cause	7 Years
PSA nadir	PSA nadir at 4-years post treatment	6 years

Collaborators and Investigators

• Sponsor: Dr. Gerard Morton
• Investigators: Principal Investigator: Gerard Morton, Sunnybrook Health Sciences Centre

Study record dates

Study Major Dates

• Study Start (Actual): December 23, 2020
• Primary Completion (Anticipated): June 23, 2023
• Study Completion (Anticipated): December 23, 2027

Study Registration Dates

• First Submitted: April 22, 2021
• First Submitted That Met QC Criteria: April 26, 2021
• First Posted (Actual): April 27, 2021

Study Record Updates

• Last Update Posted (Actual): April 12, 2023
• Last Update Submitted That Met QC Criteria: April 11, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 2734 (Insel)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No