Clinical trial · Interventional
PSMA Response in Metastasized Hormone Sensitive Prostate Cancer
Individualisation of Management With Novel Upfront Therapies in Newly Diagnosed Metastasized Prostate Cancer Using (PSMA)PET/CT Imaging
NCT05161728CI-TRIAL-00072819PET-MaNunknownN/AClinicalTrials.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)
PSMA-PET/CT response measurements after LHRH agonist and upfront therapy in men diagnosed with de novo metastasized hormonal sensitive prostate cancer.
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 |
|---|---|---|---|
| PSMA-PET/CT | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PSMA response evaluation arm
- description
- PSMA-PET/CT response evaluation, 2 months after starting hormonal therapy, 2 months after starting upfront therapy
- interventionNames
- Diagnostic Test: PSMA-PET/CT
Primary outcomes (1)
- measure
- CRPC
- timeFrame
- 18-24 mo after inclusion
- description
- Development of castration-resistant prostate cancer
Secondary outcomes (1)
- measure
- 2nd line therapy
- timeFrame
- 18-24 mo after inclusion
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Men \>18 years of age. * Mentally competent and understanding of benefits and potential burden of the study. * Written and signed informed consent. * Histological confirmed diagnosis of adenocarcinoma of the prostate. * Indicated to start on hormonal therapy (any LHRH agonist or antagonist). * Indicated to start on upfront therapy (apalutamide or abiraterone). * Any initial PSA. * Any Gleason score. * Any T-stage. * Any N-stage. * Stage M1, with multiple / high volume metastasis: More than three (\>3) metastatic lesions (any combination of either lymph node metastasis outside of pelvis, bone metastasis, or visceral metastasis), as seen on PSMA-PET/CT-imaging. As these patients are treated with palliative intent. Exclusion Criteria: * Concomitant malignancy (except from BCC of the skin). * History of prior diagnosed or treated PCa. * Any unrelated illness (e.g. active infection, inflammation or laboratory abnormalities) that in the judgment of the investigator will significantly affect patient's clinical status and/or outcome of the study. * Any known allergy for the upfront therapy. * Any known allergy for LHRH agonist or antagonist.
References
Publications (0)
Data not yet available
No reference posted for this study.