NCT05815316 is a Phase 2 clinical trial of 18F-PSMA-1007 in Prostate Cancer, sponsored by IRCCS San Raffaele.

Who is sponsoring NCT05815316?

NCT05815316 is sponsored by IRCCS San Raffaele.

What drugs are being tested in NCT05815316?

Interventions in NCT05815316: 18F-PSMA-1007.

What condition does NCT05815316 study?

NCT05815316 studies Prostate Cancer.

Is NCT05815316 still recruiting?

NCT05815316 is currently withdrawn. Last updated 13 April 2025.

Last reviewed 2025-04-13 · How we verify

NCT05815316

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

18F-PSMA PET/MRI for the Diagnosis of Clinically Significant Prostate Cancer

Withdrawn Phase 2 Last updated 13 April 2025

What this trial tests

Phase 2 trial testing 18F-PSMA-1007 in Prostate Cancer. Withdrawn.

Timeline

30 April 2023

Primary endpoint
31 July 2025

29 April 2026

Quick facts

Lead sponsor	IRCCS San Raffaele
Phase	Phase 2
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Start date	30 April 2023
Primary completion	31 July 2025
Estimated completion	29 April 2026

Drugs / interventions tested

18F-PSMA-1007 — full drug profile →

Conditions studied

Prostate Cancer — all drugs for Prostate Cancer →

Sponsor

IRCCS San Raffaele — full company profile →

Who can join

18 and older, male only, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This project aims to evaluate the role of fully hybrid PET/MRI with 18F-PSMA and multiparametric MR imaging (mpMRI) as one-stop approach for the diagnosis of clinically significant prostate cancer (csPCa). This prospective PET/MRI clinical evaluation will ideally reduce the number of false negative findings, while at the same time, allowing also to reduce the number of unnecessary prostate biopsies in patients with low-risk, clinically indolent PCa. The demonstration that, compared to mpMRI alone, the use of PET/MRI with 18F-PSMA has a superior diagnostic accuracy in detecting men with csPCa will strongly support the inclusion of 18F-PSMA as pre-biopsy triage test, in addition to mpMRI in daily clinical practice.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Prostate MRI and PSMA-PET in the Primary Diagnosis of Prostate Cancer.
Cereser L, Evangelista L, Giannarini G, Girometti R. · · 2023 · cited 12× · PMID 37627956 · DOI 10.3390/diagnostics13162697
<sup>18</sup>F-florastamin positron emission tomography/computed tomography in men with clinical suspicion of prostate cancer: A phase I prospective study.
Park SY, Moon HW, Park C, Chi DY, et al · · 2025 · PMID 41472932 · DOI 10.1016/j.prnil.2025.07.001

Verify or expand the search:

Other trials of 18F-PSMA-1007

Trials testing the same drug.

NCT06881823 — Study to Assess [177Lu]Lu-PSMA-R2 (AAA602) and [225Ac]Ac-PSMA-R2 (AAA802) in Participants With PSMA-positive HRLPC · Phase 1, PHASE2 · withdrawn
NCT06723665 — The Exploration of 18F-PSMA-1007 PET/CT Imaging in Prostate Cancer Patients · NA · enrolling by invitation
NCT05422105 — Diagnostic Performance of 18F-PSMA-1007 PET/CT in Suspected Prostate Cancer Patient · unknown
NCT05534594 — Evaluation of the 18F-PSMA Positron Emission Tomography (PET)/CT in Patients With Medullary Thyroid Cancer · NA · completed
NCT05079828 — Head-to-head Comparison of 68Ga-PSMA-11 and 18F-PSMA-1007 · NA · completed

Other recruiting trials for Prostate Cancer

Currently open trials in the same condition.

NCT06960798 — Characterizing the Genomic Landscape of Prostate Cancer in Native American Populations (NAT-Geno) · recruiting
NCT07237269 — Abi/Pred + ADT vs ADT in PSMA-Positive, Conventionally Node-Negative Prostate Cancer · Phase 2 · recruiting
NCT07234981 — PSMA-PET Guided De-escalation of Salvage Radiation Treatment in Recurrent Prostate Cancer · Phase 2 · recruiting
NCT07027124 — Neoadjuvant ADT + Darolutamide With Pembrolizumab, Followed by Adjuvant Pembrolizumab in Molecularly Stratified High-Ris · Phase 2 · recruiting
NCT07426094 — PRO-BOOST-N: Prostate-First Versus Combined Prostate and Nodal Dose Escalation in PSMA PET-Staged Node-Positive Prostate · Phase 2, PHASE3 · recruiting

Other IRCCS San Raffaele trials

Trials by the same sponsor.

NCT07454759 — Acute Sarcopenia in Hospitalized Older Adults · not yet recruiting
NCT07456462 — Making Antibody Treatments More Effective in Early Alzheimer's Disease Using 3Tesla Magnetica Resonance · NA · not yet recruiting
NCT07066878 — This Protocol Focuses on the Factors That Influence Survival, the Development of Complications and the Quality of Life B · not yet recruiting
NCT07526298 — Anticipating Irreversible Disability in Neuromyelitis Optica Spectrum Disorder: a Study to Assess Disease Activity in Ap · not yet recruiting
NCT07426471 — Delafloxacin Plasma and Tissue Concentration in Patients With Skin, Soft Tissue, and Bone and Joint Infections. · not yet recruiting

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 NCT05815316 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by IRCCS San Raffaele
Last refreshed: 13 April 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/NCT05815316.

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