The utility of 18F-fluro-deoxy-glucose (FDG) and 11C-choline (C) positron emission tomography (PET scan) for radiotheraupetic management of high risk prostate cancer patients
Phase 2
- Conditions
- Prostate cancerCancer - Prostate
- Registration Number
- ACTRN12609000108213
- Lead Sponsor
- Austin Health
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Male
- Target Recruitment
- 30
Inclusion Criteria
PSA > 20 or Gleason score 8-10 or T stage T3a,T3b or T4
Age > 18 years
Eastern Cooperative Oncology Group Performance Status (ECOG) 0 or 1
No significant medical or psychiatric illness
Written informed consent
Be prepared to undergo PET scanning
Exclusion Criteria
Any form of prostate malignancy
T1-2c prostate cancer and PSA , 10 and Gleason score < 7
Previous radical prostatectomy
Known metastatic prostate cancer
Contraindication to MRI
Contraindication to androgen ablation
Contraindication to PET
Commencement of androgen depriavation therapy prior to study entry
Previous pelvic radiotherapy
Contraindication to radiotherapy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Concordance of Choline and FDG PET with the standard imaging technologies, computed tomography (CT) and magnetic resonance imaging (MRI) by comparing the different scan results[Time=0 baseline/staging images, time= 3 months for radiotherapy treatment planning and time = 8 months for post radiotherapy review]
- Secondary Outcome Measures
Name Time Method Prostate specific antigen (PSA) levels, using blood analysis.[Time = 0 to evaluate baseline levels, time = Week 8 to determine initial hormone response, and time = 5 years for end of study review.<br>Post radiotherapy recurrence is identified either from biochemical (rising PSA levels) or clinical (physical examination) treatment failure.]