SBRT vs. Conventional Fractionation With HDR Boost for Prostate Cancer

Dr. Gerard Morton55 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prostate Cancer

Interventions

Sterotactic Body RadiotherapyRADIATION

Hypofractionated stereotactic radiation treatment.

Conventionally Fractionated RadiationRADIATION

External beam radiation therapy treatment

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

RECRUITING

Outcomes

Primary Outcomes

Treatment Feasibility

The proportion of patients accepting of being randomized divided by the number of patients approached for the study.

Time frame: 18mo - 2 years

Secondary Outcomes

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.

Time frame: 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.

Time frame: 7 years

Cumulative biochemical failure

Defined as the time of enrolment to biochemical failure (based on the Phoenix definition, PSA nadir plus 2)

Time frame: 7 years

Overall Survival

Defined as time of enrollment to death from any cause

Time frame: 7 years

Cancer Free Survival

Defined as time of enrolment to death attributed to prostate cancer

Time frame: 7 years

Metastasis Free Survival

Defined as time of enrolment to development of metastasis or death from any cause

Time frame: 7 years

Freedom From Local Failure

Defined as time of enrolment to first local recurrence

Central Contacts

Gerard Morton, MD

CONTACT

416-480-6100 gerard.morton@sunnybrook.ca

Merrylee McGuffin

CONTACT

416-480-6100 Merrylee.Mcguffin@sunnybrook.ca

Data from ClinicalTrials.gov

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