SBRT vs. Conventional Fractionation With HDR Boost for Prostate Cancer

Prostate Cancer Clinical Trial

— SHARP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04861415
• Other study ID #: 2734
• Status: Recruiting
• Phase: N/A
• Start date: December 23, 2020
• Est. completion date: December 23, 2027

Study information

• Verified date: April 2023
• Source: Sunnybrook Health Sciences Centre
• Contact: Gerard Morton, MD
• Phone: 416-480-6100
• Email: gerard.morton[@]sunnybrook.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: December 23, 2027
• Est. primary completion date: June 23, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• Sterotactic Body Radiotherapy
Hypofractionated stereotactic radiation treatment.
• Conventionally Fractionated Radiation
External beam radiation therapy treatment

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Gerard Morton

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment Feasibility	The proportion of patients accepting of being randomized divided by the number of patients approached for the study.	18mo - 2 years
Secondary	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
Secondary	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
Secondary	Cumulative biochemical failure	Defined as the time of enrolment to biochemical failure (based on the Phoenix definition, PSA nadir plus 2)	7 years
Secondary	Overall Survival	Defined as time of enrollment to death from any cause	7 years
Secondary	Cancer Free Survival	Defined as time of enrolment to death attributed to prostate cancer	7 years
Secondary	Metastasis Free Survival	Defined as time of enrolment to development of metastasis or death from any cause	7 years
Secondary	Freedom From Local Failure	Defined as time of enrolment to first local recurrence	7 years
Secondary	Freedom From Regional Failure	Defined as time of enrolment to first regional recurrence	7 years
Secondary	ADT Free Survival	Defined as time of enrolment to salvage ADT use or death from any cause	7 Years
Secondary	PSA nadir	PSA nadir at 4-years post treatment	6 years