Clinical trial · Interventional
Assessing Radio-hybrid Prostate Specific Membrane Antigen (rhPSMA-7.3) (18F) in Healthy Volunteers and Subjects With Prostate Cancer
A Phase 1, Open-label Study to Assess Safety, Biodistribution, and Internal Radiation Dosimetry of rhPSMA-7.3 (18F) Injection in Healthy Volunteers, and to Assess Safety and Investigate the Imaging Characteristics in Subjects With Prostate Cancer
NCT03995888CI-TRIAL-00103141completedPhase 1Results postedClinicalTrials.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)
A Phase 1, Open-label Study to Assess Safety, Biodistribution, and Internal Radiation Dosimetry of rhPSMA-7.3 (18F) Injection in Healthy Volunteers, and to Assess Safety and Investigate the Imaging Characteristics in Subjects With 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 |
|---|---|---|---|
| rhPSMA-7.3 (18F) Injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Healthy Volunteers
- description
- Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan
- interventionNames
- Drug: rhPSMA-7.3 (18F) Injection
- type
- EXPERIMENTAL
- label
- Patients
- description
- Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan
- interventionNames
- Drug: rhPSMA-7.3 (18F) Injection
Primary outcomes (1)
- measure
- Number of Participants With Treatment-emergent Adverse Events as Classified by MedDRA
- timeFrame
- 1 month
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Key Inclusion Criteria: Healthy Volunteers 1. Male and females 21-65 years. 2. Clinically acceptable medical history Key Exclusion Criteria: Healthy Volunteers 1. Received ionising radiation exposure from clinical trials or medical examinations or treatment in the last 12 months. 2. Suffers from claustrophobia. 3. Bilateral hip prostheses. Key Inclusion Criteria: Patients 1. Male 18-80 years. 2. Histologically confirmed adenocarcinoma of the prostate 3. Clinically acceptable medical history 4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Key Exclusion Criteria: Patients 1. Biopsy 28 days prior to enrollment. 2. Extensive metastatic disease. 3. Underlying disease which might confound interpretation. 4. Bilateral hip prostheses. 5. High energy (\>300 Kiloelectron Volt (keV)) gamma-emitting radioisotope administered within five physical half-lives, or any intravenous iodinated contrast medium within 24 hours, or any high density oral contrast medium (oral water contrast is acceptable) within 5 days prior to study drug administration. 6. X-ray contrast agent (\<24 hr for intravenous agents and \<5 days for oral agents). 7. History of claustrophobia.
References
Publications (1)
- DERIVEDMalaspina S, Oikonen V, Kuisma A, Ettala O, Mattila K, Bostrom PJ, Minn H, Kalliokoski K, Postema EJ, Miller MP, Scheinin M. Kinetic analysis and optimisation of 18F-rhPSMA-7.3 PET imaging of prostate cancer. Eur J Nucl Med Mol Imaging. 2021 Oct;48(11):3723-3731. doi: 10.1007/s00259-021-05346-8. Epub 2021 Apr 12. PMID 33846844