A Pilot Study to Develop a Technique for External Beam Radiotherapy After Radical Prostatectomy Based on MRI-Delineation of the Clinical Target Volume
Phase 2
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Male
Prostatic Neoplasms
Male
Prostatic Neoplasms
Trial Information
A Pilot Study to Develop a Technique for External Beam Radiotherapy After Radical Prostatectomy Based on MRI-Delineation of the Clinical Target Volume
Inclusion Criteria:
- Patients following radical prostatectomy for prostate adenocarcinoma with one or more
of the following adverse features:
pT2 + positive surgical margins ) pT3 ) PSA ≤ 2ng/ml Persistently elevated PSA at 3
months )
- Patients with initially undetectable PSA following prostatectomy for prostate
adenocarcinoma with subsequent PSA relapse
- Patients being planned for radiation therapy
- No evidence of distant metastases
- Age ≥ 18 years
- ECOG performance status 0 or 1
- Informed consent
Exclusion Criteria:
- Contraindications to MRI Patients weighing >136 kgs (weight limit for the scanner
tables) Patients with pacemakers, cerebral aneurysm clips, shrapnel injury or
implantable electronic devices not compatible with MRI.
- Severe claustrophobia
- Inflammatory bowel disease or collagen vascular disease
- Previous colorectal surgery
- Previous pelvic radiotherapy
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To develop a technique for MRI-delineation of the clinical target volume (CTV) for EBRT following radical prostatectomy
Principal Investigator
Cynthia Menard, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Princess Margaret Hospital, Canada
Authority:
Canada: Ethics Review Committee
Study ID:
UHN REB 04-0759-CE
NCT ID:
NCT00230438
Start Date:
January 2005
Completion Date:
Related Keywords:
- Prostatic Neoplasms
- Neoplasms
- Prostatic Neoplasms
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