Clinical trial · Interventional
PSMA PET/CT for Prostate Cancer
PSMA-PET/CT for Prostate Cancer - Phase 2 Trial
- 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)
Prostate cancer is the most frequently occurring male cancer in Belgium. Patients who have been treated for prostate cancer, i.e. by surgery and/or radiotherapy, in a substantial degree suffer from a tumor recurrence, often diagnosed by an increase in serum tumor marker Prostate Specific Antigen (PSA) within the first few years. In these patients with evidence of a tumor recurrence after primary treatment, it is important to most exactly define the location(s) of tumor, to guide appropriate therapy by surgery, radiotherapy and/or hormonotherapy. In so-called oligo-metastatic disease targeted therapy may still be curative and prevent the disease from spreading to distant locations. Therefore it is of paramount importance to have an accurate tool of medical imaging to localize all possible locations to be treated.
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-11 | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 2.0 ± 0.2 MBq/kg [18F]PSMA-11 dosing group
- description
- To define the optimal \[18F\]PSMA-11 scan protocol, the quality of the PET images from patients that received 2.0 ± 0.2 MBq/kg will be compared to the images from patients that received 4.0 ± 0.4 MBq/kg. Patients in this study arm will receive 2.0 ± 0.2 MBq/kg for acquiring the \[18F\]PSMA-11 scan. All other study parameters and procedures are identical to those in the other study arm. As for the use of radiopharmaceuticals, the ALARA ('as low as reasonably achievable') principle must be applied, this study arm is considered to be the reference.
- interventionNames
- Diagnostic Test: [18F]PSMA-11
- type
- EXPERIMENTAL
- label
- 4.0 ± 0.4 MBq/kg [18F]PSMA-11 dosing group
- description
- Concerning the dose of \[18F\]PSMA-11, the patients in this study arm will receive 4.0 ± 0.4 MBq/kg for the \[18F\]PSMA-11 scan. All other study parameters and procedures are identical to those in the other study arm
- interventionNames
- Diagnostic Test: [18F]PSMA-11
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients diagnosed with prostate cancer, either in the setting of diagnosis of biochemical recurrence after previous treatment, or at primary diagnosis and staging. Exclusion Criteria: * Age: \<18 years * Physically or mentally unfit to perform the sequential procedures * Refusal of patient to be informed about accidental findings on scans * Patients with heart failure if ejection fraction \< 45% (phase 2 trial) * History of anaphylactic shock after administration of Visipaque CT contrast (phase 2 trial)
References
Publications (1)
- DERIVEDPiron S, De Man K, Schelfhout V, Van Laeken N, Kersemans K, Achten E, De Vos F, Ost P. Optimization of PET protocol and interrater reliability of 18F-PSMA-11 imaging of prostate cancer. EJNMMI Res. 2020 Feb 24;10(1):14. doi: 10.1186/s13550-020-0593-7. PMID 32095919