Recruiting
Phase 2
Phase 3

Ablative RadioTherapy

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT04654338

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 0+

Healthy Volunteers: Not accepted

Interventions

SABR + HDR

Study Details

Brief summary:

Favorable-risk prostate cancer represent a large proportion of patients diagnosed with prostate cancer and image guided radiation therapy (IGRT) is commonly used to treat these patients using protracted courses of up to 39 treatments over 8 weeks. Stereotactic ablative body radiotherapy (SABR) protocols hold the promise of more convenience, less side effects, less cost and improved system capacity without sacrificing excellent cancer control rates. By the same token, prostate high-dose rate (HDR) brachytherapy boost has been shown to be superior to standard external beam radiation. While two HDR fractions appear to optimize patient convenience and outcomes while minimizing costs, we wanted to determine the tolerability of combining one MR-guided HDR treatment with one SABR treatment to further reduce HDR resource use while maintaining favourable treatment outcomes.

Conditions

Prostate Cancer

Study ID

NCT04654338

Start date

Jul 29, 2020

Status verified date

Jun, 2022

Completion date

Jul 29, 2028

Anticipated

Primary completion date

Jan 29, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Histologically confirmed diagnosis of adenocarcinoma of the prostate
  • Favorable risk disease defined as either:

  • Low risk disease: T1-T2c, grade group 1, PSA < 10 ng/ml or
  • Favorable intermediate risk disease: One of T2c, grade group 2, or PSA 10-20 ng/ml. Patients cannot have percent core positivity > 50%
  • Prostate volume < 60 cc as determined by US, CT or MRI
  • Ability to undergo MR imaging
  • Provide written informed consent

Exclusion Criteria:

  • Documented nodal or distant metastases
  • Previous pelvic radiotherapy
  • Previous transurethral resection of prostate, previous prostatectomy or HIFU
  • Use of androgen deprivation therapy. Use of 5-alpha-reductase inhibitors permitted
  • Poor baseline urinary function defined as International Prostate Symptom Score (IPSS) >15
  • Contra-indication to radical prostate radiotherapy e.g. connective tissue disease or inflammatory bowel disease
  • Significant medical co-morbidity rendering patient unsuitable for general anaesthesia

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intervention Arm

Interventions

SABR + HDR

One SABR treatment + one HDR brachytherapy treatment

Primary outcome measure

  • Acute Toxicities [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Merrylee McGuffin, MSc

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

Locations

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Andrew Loblaw, MD, FRCPC

416-480-4806Andrew.Loblaw@sunnybrook.ca

Merrylee McGuffin, MSc, MRT(T)

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

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Jun 27, 2023

Last verified

Jun, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2023-06-27.