SBRT vs. Conventional Fractionation With HDR Boost for Prostate Cancer

NCT04861415 | Recruiting

• 1 other identifier: 2734
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Treatment Feasibility

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

  18mo - 2 years

Secondary Outcomes (10)

• QOL

  7 years

• Treatment Toxicity

  7 years

• Cumulative biochemical failure

  7 years

• Overall Survival

  7 years

• Cancer Free Survival

  7 years

Study Arms (2)

Conventional Fractionated Radiation

ACTIVE COMPARATOR

* 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

Stereotactic Body Radiotherapy

EXPERIMENTAL

* 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

Interventions

Sterotactic Body Radiotherapy RADIATION

Hypofractionated stereotactic radiation treatment.

Also known as: SBRT

Stereotactic Body Radiotherapy

Conventionally Fractionated Radiation RADIATION

External beam radiation therapy treatment

Conventional Fractionated Radiation

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Gerard Morton: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Gerard Morton

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gerard Morton, MD

CONTACT

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

Merrylee McGuffin

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Radiation Oncologist

Study Record Dates

• First Submitted: April 22, 2021
• First Posted: April 27, 2021
• Study Start: December 23, 2020
• Primary Completion: June 23, 2023
• Study Completion (Estimated): December 23, 2027
• Last Updated: April 12, 2023

Record last verified: 2023-04

Locations

CA (1)