Clinical trial · Interventional
Experimental Study to Evaluate the Impact of 18 Fluoro-PSMA (18F-PSMA) PET / CT in the Management of Patients with Prostate Cancer.
Experimental Study to Evaluate the Impact of 18F-PSMA PET / CT in the Management of Patients with Prostate Cancer.
NCT04775602CI-TRIAL-00084528F-PSMAcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Single-center, prospective, open-label, not randomized, diagnostic phase II trial in the management of patients with prostate cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| 18F-PSMA | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-PSMA | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 18F-PSMA PET/CT
- description
- Patients with evidence of biochemical recurrence of prostate cancer radically treated, with negative results to traditional diagnostic methods or doubtful imaging of 18F- Fluoro Methyl Choline (18F-FMC) PET/CT will perform a 18F-PSMA PET/CT as a tool for searching and location of recurrence.
- interventionNames
- Drug: 18F-PSMA
Primary outcomes (1)
- measure
- Diagnostic role of 18F- PSMA PET /CT (sensitivity)
- timeFrame
- Up to 30 months
- description
- Sensitivity of 18F-PSMA PET/CT will be calculated as the ratio between the number of 18F- PSMA PET/CT positive patients and number of patients with radically treated prostate cancer with biochemical relapse and negativity of traditional morphological imaging.
Secondary outcomes (5)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients must have histologically or cytologically confirmed prostate cancer 2. Male, aged \>18 years on the day of signing and dating the informed consent form. 3. Previous radical treatment for prostate cancer (radiotherapy or surgery) 4. Negativity of all the other traditional morphological and functional imaging or doubtful imaging of 18F-FMC PET/CT 5. Patients with PSA progression defined as PSA ≥ 0.2 ng/mL and PSA rising defined as 2 subsequent values showing PSA increase at least 1 week apart. 6. Male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study and for 3 months thereafter 7. Participant is willing and able to give informed consent for participation in the study. Exclusion Criteria: 1. Hormonotherapy in the last 6 months 2. No radiotherapy in the last 6 months. 3. Participation in another clinical trial with any investigational agents within 30 days prior to prior informed consent date 4. History of allergic reactions attributed to compounds of similar chemical or biologic composition to Study Agent. 5. Medical or psychological conditions that would not permit the subject to sign the informed consent
References
Publications (0)
Data not yet available
No reference posted for this study.