Clinical trial · Interventional
18F-PSMA-1007 PET/CT Imaging in Patients with Biochemically Recurrent or High-risk Prostate Cancer
NCT04733768CI-TRIAL-00080666completedPhase 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 centre prospective cohort phase II study of 18F-PSMA-1007 PET/CT imaging in patients with biochemically recurrent or high-risk prostate cancer. Safety, biodistribution, clinical efficacy, and diagnostic accuracy will be assessed. For diagnostic accuracy comparison will be made to a contemporary (within 10 days) conventional imaging study (bone scan and CT scan).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-PSMA-1007 | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 18F-PSMA-1007 PET/CT scan
- description
- Single Arm study - all enrolled patients will undergo an experimental 18F-PSMA-1007 PET/CT scan
- interventionNames
- Diagnostic Test: 18F-PSMA-1007
Primary outcomes (5)
- measure
- Safety - immediate
- timeFrame
- Immediately (within 15 minutes) after 18F-PSMA-1007 injection
- description
- Incidence of tracer-emergent adverse events including allergic reaction (hives, difficulty breathing) or pain at the injection site
- measure
- Safety - post scan
- timeFrame
- 2.5 hours after 18F-PSMA-1007 injection
- description
- Incidence of tracer-emergent adverse events including allergic reaction (hives, difficulty breathing) or pain at the injection site
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Adult patients (≥ 18 years old) with a history of radical prostatectomy for treatment of prostate cancer, and a serum prostate specific antigen (PSA) \> 0.2 µg/L 2. Adult patients (≥ 18 years old) with a history of radiotherapy, cryotherapy, or brachytherapy for treatment of prostate cancer, and a serum PSA progressively rising to ≥ 2 µg/L (minimum two samples) OR a serum PSA doubling-time of \< 9 months 3. Adult patients (≥ 18 years old) with a history of biopsy-proven prostate cancer and high-risk features for metastatic disease prior to treatment with radical prostatectomy, radiotherapy, cryotherapy, or brachytherapy. High-risk features include a Gleason score \> 7, serum PSA \> 20 µg/L, OR minimum clinical T-stage T2c. Exclusion Criteria: 1. Unable to obtain consent 2. Weight \>225 kg (weight limitation of PET/CT scanner) 3. Unable to lie flat for 30 minutes to complete the PET-CT imaging session 4. Lack of intravenous access 5. Both CT scan of the chest, abdomen, and pelvis and 99mTc-MDP bone scan within 3 months 6. History of allergic reaction to 18F-PSMA-1007 or 99mTc-MDP
References
Publications (1)
- DERIVEDStanton Z, Woloschuk B, Tamm A, Hung R, Trivedi A, Kolinsky M, Usmani N, Rowe L, Moore R, Wuest F, Abele J. 18F-PSMA-1007 PET/CT Demonstrates Higher Accuracy for Biochemically Recurrent Prostate Cancer Compared to Contemporary Conventional Imaging. Adv Urol. 2026 Jul 5;2026:8550174. doi: 10.1155/aiu/8550174. eCollection 2026. PMID 42440684