Single Fractions SBRT in the Treatment of Prostate Cancer: A Phase I Study

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• Histologically proven adenocarcinoma of the prostate. Tl-2b (AJCC 7th edition) Gleason score 6 or 7 (3+4)) or Gleason 7(4+3) and recent PSA \< 10 (less than 30 days; must obtained \>90 days from stopping dutasteride or \>30 days from stopping finasteride)

• Recent PSA under 15 ng/dL (less than 30 days; must obtained \>90 days from stopping dutasteride or \>30 days from stopping finasteride) OR Gleason 7(4+3) and recent PSA \< 10 (less than 30 days; must obtained \>90 days from stopping dutasteride or \>30 days from stopping finasteride)

• International Prostate Symptom Score \<16 Prostate gland volume\< 80cc

• Zubrod Performance Status 0-1 within 60 days prior to registration

• Age \>: 18

• Patient must be able to provide study-specific informed consent prior to study entry.

Locations
Other Locations
Canada
McGill University Health Centre-Cedars Cancer Centre
RECRUITING
Montreal
Contact Information
Primary
Marianna Perna
marianna.perna@muhc.mcgill.ca
514-934-1934
Backup
Tatiana Carvalho
tatiana.carvalho@muhc.mcgill.ca
514-934-1934
Time Frame
Start Date: 2018-11-07
Estimated Completion Date: 2027-12-20
Participants
Target number of participants: 12
Treatments
Experimental: Single Fraction SBRT in the treatment of prostate cancer
Prior to treatment, a hydrogel spacer will be inserted between the recutm and prostate. A urinary catheter will also be inserted in the bladder. A single dose of 19Gy will be delivered with an IMRT technique. The treatment should last approximately 30 minutes. After the treatment, the urinary catheter will be removed.
Sponsors
Leads: Fabio Cury
Collaborators: Boston Scientific Corporation

This content was sourced from clinicaltrials.gov