Status:
UNKNOWN
Prostate Boost Irradiation With Stereotactic Body RT (SBRT)
Lead Sponsor:
Juravinski Cancer Center
Collaborating Sponsors:
Sanofi
Conditions:
Prostate Cancer
Eligibility:
MALE
18-85 years
Phase:
PHASE2
Brief Summary
A randomized controlled open-label trial in patients with high risk prostate cancer. Eligible and consenting patients will be randomly allocated to receive stereotactic body radiotherapy (SBRT) boost ...
Detailed Description
In this study we investigate stereotactic body radiotherapy (SBRT) as a boost radiotherapy treatment, following pelvic radiotherapy, in patients with high risk prostate cancer (PrCa) treated with Andr...
Eligibility Criteria
Inclusion
- Histological and or clinical diagnosis of high risk adenocarcinoma of the prostate within six months of entry (stage T3 or higher and/or Gleason score 8 or higher and/or initial PSA level above 20;)
- No radiographic evidence of metastatic disease to the abdomen, lymph nodes, bone or other distant organs; determined by standard staging investigations (bone scan and CT-scan of the abdomen and pelvis) or incidental findings (localized N0, M0 disease)
- Patient is able to complete the quality of life questionnaires in English.
- Informed consent obtained
Exclusion
- • Histological diagnosis of carcinoma of the prostate more than six months prior to potential registration date;
- Previous treatment for carcinoma of the prostate (other than biopsy or TURP), including bilateral orchiectomy;
- Patients previously on more than twelve weeks of hormone therapy for their PrCa;
- Past history of other malignancies except: adequately treated non-melanoma skin cancer or other solid tumours curatively treated with no evidence of disease for more than 3 years;
- Contraindications to placement of gold seeds for daily prostate localization;
- Previous pelvic RT and/or significant pelvic surgery;
- Severe diverticular or inflammatory bowel disease (as determined by the treated radiation oncologist)
- Previous hip replacement
- PSA over 50
- IPSS 20 or higher
- TRUS-based prostate
- volume of \> 80 cc
Key Trial Info
Start Date :
January 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03380806
Start Date
January 1 2019
End Date
January 1 2022
Last Update
June 4 2020
Active Locations (2)
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1
Juravinski Cancer Centre
Hamilton, Ontario, Canada
2
Walker Family Cancer Centre ,Niagara Health - St. Catharines Site
St. Catharines, Ontario, Canada