Evaluating a new imaging method for prostate cancer diagnosis

Prospective, Multi-Center Study to Assess the Diagnostic Performance of [18F]PSMA-1007 PET/CT Imaging in Patients With Newly-Diagnosed High-Risk or Very-High-Risk Prostate Cancer

This study is testing a new imaging method to see if it can better identify prostate cancer in men who have just been diagnosed with high-risk forms of the disease.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 380 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: ABX advanced biochemical compounds GmbH (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 18 sites (Nancy and 17 other locations)
• Trial ID: NCT06122584 on ClinicalTrials.gov

What this trial studies

This study assesses the diagnostic performance of [18F]PSMA-1007 PET/CT imaging in patients who have been newly diagnosed with high-risk or very-high-risk prostate cancer. The trial aims to determine how effectively this imaging technique can identify the presence of cancer and guide treatment decisions. Participants must have biopsy-proven localized prostate adenocarcinoma and meet specific high-risk criteria as defined by the NCCN guidelines. The study will involve patients who have undergone conventional imaging within the last 60 days to ensure accurate assessment.

Who should consider this trial

Good fit: Ideal candidates are males aged 18 and older with newly diagnosed, high-risk prostate adenocarcinoma who prefer curative surgery.

Not a fit: Patients with low-risk prostate cancer or those who do not meet the eligibility criteria will not benefit from this study.

Why it matters

Potential benefit: If successful, this imaging method could improve the accuracy of prostate cancer diagnosis and treatment planning.

How similar studies have performed: Other studies have shown promising results with similar imaging approaches, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

1. The patient (male) is aged 18 years or above.
2. The patient is able to understand the information presented to him concerning the nature, scope, and consequences of the trial as set out in the information provided to the patient AND has provided written informed consent to participate.
3. The patient has newly diagnosed, biopsy-proven, clinically localized prostate adenocarcinoma, and curative prostatectomy with extended pelvic lymph node dissection is his preferred course of treatment.
4. The patient has at least high-risk disease as defined by the NCCN guidelines (version 1.2023). That is, the presence of any one or more of the following:

   * Overall ISUP grade group 4 or 5,
   * Clinical category T3a or greater,
   * Serum PSA level greater than 20 ng/ml.
5. The patient has undergone conventional imaging (CT or MRI, and bone scan if clinically indicated) to detect the presence of pelvic nodal involvement and bone or visceral metastases within 60 days of the planned PET-CT procedure.

Exclusion Criteria:

1. Patients for whom radical prostatectomy is not clinically appropriate or the patient is otherwise unlikely to undergo radical prostatectomy with extensive pelvic lymph node dissection.
2. The patient has received any therapy - be it radiation, surgical or drug therapy - for his prostate cancer.
3. The patient has any contraindication(s) for and/or known hypersensitivity to any constituent(s) of \[18F\]PSMA-1007.
4. The patient is not able to have PET-CT scans (for example, because of weight, claustrophobia, or inability to lie still for the duration of the scan).
5. The patient is closely affiliated to the investigation site; e.g. is a first-degree relative of the investigator.
6. At the time of screening, the patient is receiving any other investigational agent(s), or he has received any such agent(s) within the previous 30 days, or he is scheduled to receive any such agent(s) in the period up to the planned date for the last study visit.
7. The patient has previously been enrolled in this trial.
8. The patient has previously undergone PET imaging with any PSMA-avid product.
9. The patient has histological evidence of small-cell carcinoma of the prostate.
10. The patient is clinically unstable or requires emergency treatment.
11. The patient has any mental condition rendering him incapable of understanding the nature, scope, and consequences of the trial as set out in the information given to the patient.

Where this trial is running

Nancy and 17 other locations

• CHRU de Nancy — Nancy, France (Recruiting)
• Carl Gustav Carus Faculty of Medicine, TUD Dresden — Dresden, Germany (Recruiting)
• University Hospital Düsseldorf — Düsseldorf, Germany (Recruiting)
• St. Antonius Hospital — Gronau, Germany (Recruiting)
• University Hospital Hamburg-Eppendorf — Hamburg, Germany (Recruiting)
• University Hospital Leipzig — Leipzig, Germany (Recruiting)
• Klinikum rechts der Isar, TUM — München, Germany (Active_not_recruiting)
• University Hospital Münster — Münster, Germany (Recruiting)
• Universitätsmedizin Rostock — Rostock, Germany (Recruiting)
• IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" — Meldola, Italy (Recruiting)
• IRCCS Ospedale Sacro Cuore-Don Calabria — Verona, Italy (Recruiting)
• The University of Osaka Hospital — Osaka, Japan (Recruiting)
• National Cancer Center — Tokyo, Japan (Recruiting)
• Cwz — Nijmegen, Netherlands (Recruiting)
• Radboud UMC — Nijmegen, Netherlands (Recruiting)
• Hospital Del Mar — Barcelona, Spain (Recruiting)
• Hospital Vall d'Hebron — Barcelona, Spain (Recruiting)
• Hospital Vithas Valencia 9 de Octubre — Valencia, Spain (Active_not_recruiting)

Study contacts

• Study coordinator: Alexander Hoepping, Dr.

Conditions Prostate Cancer