â??Use of Gallium-68PET-CT in the Diagnosis and Follow-up of patients with Prostate Cancerâ??
Not Applicable
- Conditions
- Health Condition 1: null- Prostate Ca patients following RP or EBRT, Sr. PSA levels between 0.2-4 ng/mL, or Sr. PSA between 4-10 ng/mL with negative imaging investigation (BS/MR/CT). Gleason Score â?¥ 7
- Registration Number
- CTRI/2018/07/014933
- Lead Sponsor
- International Atomic Energy Agency
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Patients with histologically proven diagnosis of PCa
2. Patients with PCa that following RP or EBRT (with or without any adjuvant therapy) with serum levels of PSA between 0.2 ng/mL and 4 ng/mL, or PSA between 4-10 ng/mL with necessary negtive imaging investigation (BS, MR, CT).
3. Gleason Score >= 7
4. Age >= 35 years
Exclusion Criteria
1.Untreated patient with radical therapy (RP or EBRT)
2.Previous cancer from other origin except non-melanoma skin cancer
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary: To evaluate the sensitivity, specificity, positive predictive value (PPV) and <br/ ><br> negative predictive value (NPV) in detecting the presence of local and/ or systemic disease in early laboratory recurrence.Timepoint: Primary: To evaluate the sensitivity, specificity, positive predictive value (PPV) and <br/ ><br> negative predictive value (NPV) in detecting the presence of local and/ or systemic disease in early laboratory recurrence.
- Secondary Outcome Measures
Name Time Method 1.To record the number of lesions, SUV max in prostate bed, lymph nodes, extranodal lesions. <br/ ><br>2.Compare the performance of PSMA PET/CT with clinical prognostic factors (Gleason, PSA, PSA kinetics) used in the normal care pathway. <br/ ><br>3.Compare the performance of PSMA PET/CT with conventional imaging methods (CT, MR AND BS) used in the normal care pathway. <br/ ><br>4.Evaluate impact of PSMA PET/CT on clinical management <br/ ><br>Timepoint: 48 months