Actively Recruiting

Phase Not Applicable
Age: 18Years +
MALE
NCT04004312

Single Fractions SBRT for Prostate Cancer

Led by Fabio Cury · Updated on 2025-06-25

12

Participants Needed

1

Research Sites

475 weeks

Total Duration

On this page

Sponsors

F

Fabio Cury

Lead Sponsor

B

Boston Scientific Corporation

Collaborating Sponsor

AI-Summary

What this Trial Is About

It is a phase I study of radical hypofractionation delivering one single fraction of SBRT in patients with low- and favorable intermediate-risk prostate cancer that will undergo placement of the SpaceOAR hydrogel prior to treatment. Our hypothesis is that treatments can be safely delivered in one single fraction using SBRT provided the separation between the prostate and rectum is increased using the hydrogel

CONDITIONS

Official Title

Single Fractions SBRT for Prostate Cancer

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed adenocarcinoma of the prostate with Tl-2b stage (AJCC 7th edition)
  • Gleason score 6 or 7 (3+4) or Gleason 7 (4+3)
  • Recent PSA less than 10 ng/dL within 30 days (must be obtained more than 90 days after stopping dutasteride or more than 30 days after stopping finasteride)
  • Alternatively, recent PSA under 15 ng/dL within 30 days or Gleason 7 (4+3) and recent PSA less than 10 ng/dL within 30 days
  • International Prostate Symptom Score less than 16
  • Prostate gland volume under 80 cc
  • Zubrod Performance Status 0-1 within 60 days prior to registration
  • Age 18 years or older
  • Ability to provide study-specific informed consent prior to entry
Not Eligible

You will not qualify if you...

  • Choosing another treatment like surgery or active surveillance
  • Prior or concurrent invasive malignancy except non-melanomatous skin cancer unless disease-free for at least 5 years
  • Carcinoma of the bladder including in situ or superficial bladder cancer
  • Evidence of distant metastases
  • Regional lymph node involvement
  • Previous radical prostate surgery, cryosurgery, or high-intensity focused ultrasound for prostate cancer
  • Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
  • Previous hormonal therapy including LHRH agonists/antagonists, anti-androgens, estrogens, or surgical castration
  • Use of finasteride within 30 days prior to registration
  • Use of dutasteride within 90 days prior to registration
  • Previous or current cytotoxic chemotherapy for prostate cancer
  • Severe active co-morbidities such as unstable angina, congestive heart failure, recent myocardial infarction within 6 months
  • Acute bacterial or fungal infection requiring intravenous antibiotics at registration
  • Chronic obstructive pulmonary disease exacerbation or respiratory illness requiring hospitalization
  • Hepatic insufficiency causing jaundice or coagulation defects
  • Acquired Immune Deficiency Syndrome (AIDS) based on current CDC definition

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

McGill University Health Centre-Cedars Cancer Centre

Montreal, Quebec, Canada, H4A 3J1

Actively Recruiting

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Research Team

M

Marianna Perna

CONTACT

T

Tatiana Carvalho

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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Single Fractions SBRT for Prostate Cancer | DecenTrialz