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â??Use of Gallium-68PET-CT in the Diagnosis and Follow-up of patients with Prostate Cancerâ??

â??Use of PET-CT with Gallium-68 labelled prostate Specific Membrane Antigen in the Diagnosis and Follow-up of patients with Prostate Cancerâ??

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2018/07/014933
Enrollment
100
Registered
2018-07-18
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Interventions

None listed

Sponsors

International Atomic Energy Agency
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: 1. Untreated patient with radical therapy (RP or EBRT) 2. Previous cancer from other origin except non-melanoma skin cancer

Design outcomes

Primary

MeasureTime frame
Primary: To evaluate the sensitivity, specificity, positive predictive value (PPV) and 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 negative predictive value (NPV) in detecting the presence of local and/ or systemic disease in early laboratory recurrence.—

Secondary

MeasureTime frame
1. To record the number of lesions, SUV max in prostate bed, lymph nodes, extranodal lesions. 2. Compare the performance of PSMA PET/CT with clinical prognostic factors (Gleason, PSA, PSA kinetics) used in the normal care pathway. 3. Compare the performance of PSMA PET/CT with conventional imaging methods (CT, MR AND BS) used in the normal care pathway. 4. Evaluate impact of PSMA PET/CT on clinical management Timepoint: 48 months—

Countries

Azerbaijan, Belgium, Brazil, Chile, Colombia, Denmark, Germany, India, Israel, Italy, Jordan, Kuwait, Lebanon, Malaysia, Pakistan, Poland, South Africa, Turkey, Uruguay

Contacts

Public ContactDr Archi Agrawal

Tata Memorial Hospital

drarchi23@gmail.com2224177016

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026