Recruiting

SBRT vs. Conventional Fractionation

Sponsor:

Dr. Gerard Morton

Code:

NCT04861415

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Sterotactic Body Radiotherapy

Conventionally Fractionated Radiation

Study Details

Brief summary:

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

Conditions

Prostate Cancer

Study ID

NCT04861415

Start date

Dec 23, 2020

Status verified date

Apr, 2023

Completion date

Dec 23, 2027

Anticipated

Primary completion date

Jun 23, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

55 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

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

Interventions

Sterotactic Body Radiotherapy

Hypofractionated stereotactic radiation treatment.

Conventionally Fractionated Radiation

External beam radiation therapy treatment

Primary outcome measure

  • Treatment Feasibility [ Time Frame: 18mo - 2 years ]

Central Contacts and Locations

Central contacts

Gerard Morton, MD

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

Merrylee McGuffin

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

Locations

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Gerard Morton, MD, FRCPC

416-480-6100

Merrylee McGuffin, MSc, MRT(T)

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

Principal Investigator:

Mark Corkum

More Information

Sponsor

Dr. Gerard Morton

Last update posted

Apr 12, 2023

Last verified

Apr, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dr. Gerard Morton on 2023-04-12.