NCT05004285 is a Phase 3 clinical trial of [F-18]Florastamin in High Risk Prostate Carcinoma, sponsored by FutureChem.

Who is sponsoring NCT05004285?

NCT05004285 is sponsored by FutureChem.

What drugs are being tested in NCT05004285?

Interventions in NCT05004285: [F-18]Florastamin.

What condition does NCT05004285 study?

NCT05004285 studies High Risk Prostate Carcinoma.

Is NCT05004285 still recruiting?

NCT05004285 is currently active, enrolled. Last updated 12 March 2025.

Last reviewed 2025-03-12 · How we verify

NCT05004285

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Evaluate the Clinical Usefulness of [F-18]Florastamin PET/CT Imaging Diagnosis Compared to MRI Diagnosis

Active, enrolled Phase 3 Last updated 12 March 2025

What this trial tests

Phase 3 trial testing [F-18]Florastamin in High Risk Prostate Carcinoma in 398 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

28 April 2021

Primary endpoint
1 June 2025

1 June 2025

Quick facts

Lead sponsor	FutureChem
Phase	Phase 3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	398
Start date	28 April 2021
Primary completion	1 June 2025
Estimated completion	1 June 2025
Sites	5 locations across South Korea

Drugs / interventions tested

[F-18]Florastamin — full drug profile →

Conditions studied

High Risk Prostate Carcinoma — all drugs for High Risk Prostate Carcinoma →

Sponsor

FutureChem — full company profile →

Who can join

20 and older, male only, with High Risk Prostate Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Only in subjects who satisfy the inclusion/exclusion criteria, a single dose of \[F-18\]Florastamin at 10 ± 1 mCi is IV administered at Visit 2, and \[F-18\]Florastamin PET/CT images are obtained from the head to thigh after 110 ± 10 minutes.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for High Risk Prostate Carcinoma

Currently open trials in the same condition.

NCT06384222 — Hyperpolarized (HP) 13C Pyruvate Magnetic Resonance Imaging (MRI) for Response Monitoring to Neoadjuvant Abiraterone · Phase 2 · recruiting
NCT06204341 — Towards Optimal Treatment for High Risk Prostate Cancer · NA · recruiting
NCT06461793 — Safety of Dose Escalation in Definitive Hypofractionated Radiation Therapy and Hormone Therapy With SpaceOAR TM for Pati · Phase 2 · recruiting

Other FutureChem trials

Trials by the same sponsor.

NCT05579184 — [Lu-177]Ludotadipep in Castration-resistant Prostate Cancer(CRPC): Investigation of Drug and Application_2 · Phase 2 · active not recruiting
NCT05458544 — [Lu-177]Ludotadipep in Castration-resistant Prostate Cancer(CRPC): Investigation of Drug and Application · Phase 1, PHASE2 · recruiting
NCT04509557 — [177Lu]Ludotadipep Treatment in Patients With Metastatic Castration-resistant Prostate Cancer. · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05004285 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by FutureChem
Last refreshed: 12 March 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05004285.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing