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OncoMatch/Clinical Trials/NCT06122584

Diagnostic Performance of [18F]PSMA-1007 PET/CT Imaging in Patients With Newly-Diagnosed Prostate Cancer

Is NCT06122584 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies [18F]PSMA-1007 for prostate cancer.

Phase 3RecruitingABX advanced biochemical compounds GmbHNCT06122584Data as of Jun 2026Location: International · 6 countries

Treatment: [18F]PSMA-1007This study assess the Diagnostic Performance of \[18F\]PSMA-1007 PET/CT Imaging in Patients with Newly-Diagnosed High-Risk or Very-High-Risk Prostate Cancer

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Extracted eligibility criteria

Treatments studied

Other

[18F]PSMA-1007

Cancer type

Prostate Cancer

Disease stage

Required: Stage CLINICALLY LOCALIZED, T3A OR GREATER (NCCN)

Grade: ISUP grade group 4ISUP grade group 5 (ISUP)

newly diagnosed, biopsy-proven, clinically localized prostate adenocarcinoma; high-risk disease as defined by the NCCN guidelines (version 1.2023): Overall ISUP grade group 4 or 5, Clinical category T3a or greater, Serum PSA level greater than 20 ng/ml

Demographics

Male only

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: any therapy for prostate cancer

The patient has received any therapy - be it radiation, surgical or drug therapy - for his prostate cancer.

Cannot have received: investigational agent

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.

Cannot have received: PSMA-avid PET imaging agent

previously undergone PET imaging with any PSMA-avid product

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT06122584 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

What disease stage is eligible?

Stage CLINICALLY LOCALIZED or T3A OR GREATER is required.

Is this trial open to female patients?

No. This trial enrolls male patients only.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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