Head-to-head Comparison of 68Ga-PSMA-11 and 18F-PSMA-1007

NCT05079828 | Completed DMC

• 1 other identifier: 2020-02903
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to provide robust data on the head-to-head comparison of the two ligands of the prostate specific membrane antigen (PSMA) available in Switzerland for positron emission tomography (PET)-imaging, i.e. 68Ga-PSMA-11 und 18F-PSMA-1007.

Conditions

Prostate Cancer

Keywords

PSMA; 68Ga-PSMA-11; 18F-PSMA-1007; PET/CT; recurrent prostate cancer

Outcome Measures

Primary Outcomes (1)

• Patient-level detection rate

  The primary endpoint is the proportion of patients with a pathological PSMA-positive finding (= patient-based sensitivity) at one time-point (2h) with the existing standard-of-care (68Ga-PSMA-11) compared to the new tracer (18F-PSMA-1007).

  3-6 months following final scan

Secondary Outcomes (7)

• Comparison of tracer kinetics

  For the first n=10 individuals, expected to be after 3 months

• Per region-based detection rate

  Confirmed by 12 months' follow up from date of scan to a composite standard

• Interreader reliability

  Within 3-6 months of last scan

• Region based PPV

  12 months from the last scan

• Lesion semiquantitative radiotracer uptake

  Within 6 months of scan date

Study Arms (2)

Arm 1

ACTIVE COMPARATOR

Patients receive first a PET/CT with 68Ga-PSMA-11 and a second PET/CT with 18F-PSMA-1007

Diagnostic Test: 18F-PSMA-1007; Diagnostic Test: 68Ga-PSMA-11

Arm 2

ACTIVE COMPARATOR

Patients receive first a PET/CT with 18F-PSMA-1007 and a second with 68Ga-PSMA-11

Diagnostic Test: 18F-PSMA-1007; Diagnostic Test: 68Ga-PSMA-11

Interventions

18F-PSMA-1007 DIAGNOSTIC_TEST

PET/CT scan using 18F-PSMA-1007

Arm 1; Arm 2

68Ga-PSMA-11 DIAGNOSTIC_TEST

PET/CT scan using 68Ga-PSMA-11

Arm 1; Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with known biochemical recurrence of a histologically confirmed prostate cancer post radical prostatectomy, defined as two consecutive prostate specific antigen (PSA) values \> 0.2 ng/ml:
• Post prostatectomy: Patients \> 18 y/o
• PSA measured within ± 4 weeks of the first PSMA-PET/CT
• Patients providing written informed consent
• No change in PC treatment in the period between the first and second scans

You may not qualify if:

• Patients receiving androgen deprivation therapy (ADT) within 6 months prior to the PSMA-PET/CT
• Patients with contraindication to diuresis with 20mg Furosemide
• Patients with renal dialysis or relevant renal impairment (eGFR \< 35 ml/min)
• Inability to provide written informed consent
• Inability to schedule and attend two consecutive PET examinations
• Patients undergoing active treatment for a second non-prostatic malignancy at the time of the first scan.
• Known sensitivity or allergy to PSMA-ligands or one of the components of the radiotracer solutions used.

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Inselspital, Universitätsspital Bern

Bern, 3010, Switzerland

Location

Related Publications (1)

• Alberts I, Butikofer L, Rominger A, Afshar-Oromieh A. A randomised, prospective and head-to-head comparison of [68Ga]Ga-PSMA-11 and [18F]PSMA-1007 for the detection of recurrent prostate cancer in PSMA-ligand PET/CT-Protocol design and rationale. PLoS One. 2022 Jul 19;17(7):e0270269. doi: 10.1371/journal.pone.0270269. eCollection 2022.

  PMID: 35853017 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Axel Rominger, MD

  Inselspital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Independent read by masked investigators for assessment of the primary outcome.
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomised to receive a PET/CT with either 18F-PSMA-1007 and a second exam with 68Ga-PSMA-11 or vice-versa, in the reverse order.

Study Record Dates

• First Submitted: July 13, 2021
• First Posted: October 15, 2021
• Study Start: July 7, 2022
• Primary Completion: May 1, 2024
• Study Completion: October 30, 2024
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)