Actively Recruiting

Phase 2
Phase 3
MALE
NCT04654338

2 Ablative RadioTherapy Treatments for Prostate Cancer

Led by Sunnybrook Health Sciences Centre · Updated on 2023-06-27

30

Participants Needed

1

Research Sites

417 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

2 Ablative RadioTherapy Treatments for Prostate Cancer

Who Can Participate

MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed diagnosis of adenocarcinoma of the prostate
  • Favorable risk disease defined as either low risk: T1-T2c, grade group 1, PSA less than 10 ng/ml, or favorable intermediate risk: one of T2c, grade group 2, or PSA 10-20 ng/ml, with percent core positivity 50% or less
  • Prostate volume less than 60 cc as determined by ultrasound, CT or MRI
  • Ability to undergo MR imaging
  • Provide written informed consent
Not Eligible

You will not qualify if you...

  • Documented nodal or distant metastases
  • Previous pelvic radiotherapy
  • Previous transurethral resection of prostate, previous prostatectomy or high-intensity focused ultrasound
  • Use of androgen deprivation therapy (5-alpha-reductase inhibitors permitted)
  • Poor baseline urinary function defined as International Prostate Symptom Score greater than 15
  • Contraindication to radical prostate radiotherapy such as connective tissue disease or inflammatory bowel disease
  • Significant medical co-morbidity rendering patient unsuitable for general anaesthesia

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada, M4N 3M5

Actively Recruiting

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Research Team

M

Merrylee McGuffin, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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