Piflufolastat clinical trials
Piflufolastat is named as an intervention in 3 current clinical trials in our USA, France, UK, China, Germany, Spain, Italy, Netherlands, Belgium, Switzerland, Austria, Czechia, Canada, Brazil, Mexico, Japan, Taiwan, Singapore, Australia and Israel registers. 2 are recruiting patients now. The most common phase is Phase 3. The sponsor with the most trials is Novartis Pharmaceuticals (1). The most-studied condition is Oligometastatic Prostate Cancer (OMPC). The EU clinical trials register (CTIS) separately lists 3 authorised or ongoing trials.
Patient leaflets for Piflufolastat
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Trials by status
Trials by phase
Clinical trials of Piflufolastat
3 trials| Study | Phase | Status | Lead sponsor | Registers |
|---|---|---|---|---|
|
Impact of Fluciclovine (18F) PET (Positron Emission Tomography) on the Management of Prostate Cancer Following Negative or Equivocal PSMA (Prostate-Specific Membrane Antigen) PET Imaging at the Time of Biochemical Recurrence
NCT07569926 · ClinicalTrials.gov ↗ · Prostate Cancer
|
Phase 4 | Recruiting | Blue Earth Diagnostics | USA |
|
An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation in PSMA Positive OMPC.
NCT05939414 · Oligometastatic Prostate Cancer (OMPC)
|
Phase 3 | Recruiting | Novartis Pharmaceuticals | UK, USA, China, Germany, France, Spain, Italy, Netherlands, Belgium, Switzerland, Austria, Czechia, Canada, Brazil, Mexico, Japan, Taiwan, Singapore, Australia, Israel |
|
Study of 18FET PET in Functional Pituitary Adenomas With Indeterminate MRI Findings
NCT07360548 · ClinicalTrials.gov ↗ · Functional Pituitary Adenomas
|
Phase 2 | Not yet open | University Hospital, Lille | France |
Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Piflufolastat in the EU trials register (CTIS)
3 trialsAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Piflufolastat. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.
| Study | Phase | Status | Sponsor | Countries |
|---|---|---|---|---|
|
AcTFirst: A phase III, open-label, multi-center, randomized study comparing AAA817+ARPI versus standard of care in adult participants with PSMA-positive metastatic castration resistant prostate cancer
2024-512340-32-01 · CTIS ↗ · Neoplasms
|
Phase 3 | Authorised | Novartis Pharma AG | Czechia, Belgium, Netherlands + 2 more |
|
ECETEP : Pilot study evaluating PSMA positron emission tomography for monitoring clinically significant prostate cancer after focal HIFU treatment
2026-525181-22-00 · Diagnosis
|
Phase 4 | Authorised | Centre Hospitalier Universitaire De Toulouse | France |
|
(ASK-PD0-CS002) Long-Term Safety and Efficacy Follow-up of AB-1005 Gene Transfer Study Participants with Parkinson’s Disease or Multiple System Atrophy
2025-522653-19-00 · CTIS ↗ · Nervous System Diseases
|
Phase 4 | Authorised | Askbio Inc | Poland |
Conditions studied with Piflufolastat
3 conditionsSponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Novartis Pharmaceuticals | 1 |
| Blue Earth Diagnostics | 1 |
| University Hospital, Lille | 1 |
By country register
A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.
Related compounds
Questions about Piflufolastat trials
How many clinical trials are testing Piflufolastat?
3 current trials in our USA, France, UK, China, Germany, Spain, Italy, Netherlands, Belgium, Switzerland, Austria, Czechia, Canada, Brazil, Mexico, Japan, Taiwan, Singapore, Australia and Israel registers name Piflufolastat (also registered as 18F) as a drug or biological intervention, as of the registry sync on 11 November 2026. Completed and withdrawn studies are not counted.
Are Piflufolastat trials recruiting patients?
Yes. 2 of the 3 trials are recruiting: 2 with sites in USA, 1 with sites in France, 1 with sites in UK, 1 with sites in China, 1 with sites in Germany, 1 with sites in Spain, 1 with sites in Italy, 1 with sites in Netherlands, 1 with sites in Belgium, 1 with sites in Switzerland, 1 with sites in Austria, 1 with sites in Czechia, 1 with sites in Canada, 1 with sites in Brazil, 1 with sites in Mexico, 1 with sites in Japan, 1 with sites in Taiwan, 1 with sites in Singapore, 1 with sites in Australia and 1 with sites in Israel. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Piflufolastat clinical trials?
Novartis Pharmaceuticals (1), Blue Earth Diagnostics (1) and University Hospital, Lille (1). The number in brackets is how many trials each organisation leads.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Piflufolastat works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Piflufolastat works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Piflufolastat (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 11 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.