NCT03465579 (BIOPSTAGE) is a NA clinical trial of pelvic MRI in 68Ga-PSMA PET/CT Guided Prostate Biopsy, sponsored by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS.

Who is sponsoring NCT03465579?

NCT03465579 is sponsored by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS.

What drugs are being tested in NCT03465579?

Interventions in NCT03465579: pelvic MRI, 68Ga-PSMA PET/CT.

What condition does NCT03465579 study?

NCT03465579 studies 68Ga-PSMA PET/CT Guided Prostate Biopsy, Mp-3TMRI Guided Prostate Biopsy, Prostate Cancer, TNM Staging, Diagnosis.

Is NCT03465579 still recruiting?

NCT03465579 is currently terminated. Last updated 30 January 2025.

Last reviewed 2025-01-30 · How we verify

NCT03465579: BIOPSTAGE

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

Mp-3TMRI and 68Ga-PSMA PET/CT Guided Prostate Biopsy and Tumor Node Metastasis (TNM) Staging.

Terminated NA Last updated 30 January 2025

What this trial tests

NA trial testing pelvic MRI in 68Ga-PSMA PET/CT Guided Prostate Biopsy in 261 participants. Terminated before completion.

Timeline

23 May 2018

Primary endpoint
3 September 2024

3 September 2024

Quick facts

Lead sponsor	Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	261
Start date	23 May 2018
Primary completion	3 September 2024
Estimated completion	3 September 2024
Sites	2 locations across Italy

Drugs / interventions tested

pelvic MRI
68Ga-PSMA PET/CT — full drug profile →

Conditions studied

68Ga-PSMA PET/CT Guided Prostate Biopsy — all drugs for 68Ga-PSMA PET/CT Guided Prostate Biopsy →
Mp-3TMRI Guided Prostate Biopsy — all drugs for Mp-3TMRI Guided Prostate Biopsy →
Prostate Cancer — all drugs for Prostate Cancer →
TNM Staging — all drugs for TNM Staging →

Sponsor

Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS — full company profile →

Who can join

18 and older, male only, with 68Ga-PSMA PET/CT Guided Prostate Biopsy or Mp-3TMRI Guided Prostate Biopsy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

BIOPSTAGE is a prospective, non-randomized, diagnostic, multi-cohort investigational study to evaluate the impact of pelvic Multi-parametric 3-Tesla magnetic resonance imaging (mp-3TMRI) and whole-body 68Ga-PSMA PET/CT for diagnosis of clinically-significant prostate cancer and pre-surgical staging.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Toward a PSMA PET-mpMRI pathway for biopsy decision-making in men with suspected prostate cancer: interim results from the prospective BIOPSTAGE trial.
Celli M, Gunelli R, Ferroni F, Costantini M, et al · · 2025 · PMID 41561764 · DOI 10.3389/fonc.2025.1720861

Verify or expand the search:

Other Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS trials

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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 NCT03465579 (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 Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Last refreshed: 30 January 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/NCT03465579.

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