CompletedPhase 1

Assessing Radio-hybrid Prostate Specific Membrane Antigen (rhPSMA-7.3) (18F) in Healthy Volunteers and Subjects With Prostate Cancer

Finland24 participantsStarted 2019-06-11

Plain-language summary

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.

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. Male and females 21-65 years.
✓. Clinically acceptable medical history

Exclusion criteria

✕. Received ionising radiation exposure from clinical trials or medical examinations or treatment in the last 12 months.
✕. Suffers from claustrophobia.
✕. Bilateral hip prostheses.
✕. Male 18-80 years.
✕. Histologically confirmed adenocarcinoma of the prostate
✕. Clinically acceptable medical history
✕. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
✕. Biopsy 28 days prior to enrollment.

What they're measuring

Number of Participants With Treatment-emergent Adverse Events as Classified by MedDRA

Timeframe: 1 month

Trial details

NCT IDNCT03995888

SponsorBlue Earth Diagnostics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-04-16

Results submitted2025-12-10

View on ClinicalTrials.gov More Prostate Cancer trials