PSMA vs. FDHT PET/CT for restaging recurrent prostate cancer

Comparison of 68Ga-PSMA PET/CT with 18F-FDHT PET/CT for re-staging patients with recurrent prostate cancer after radiotherapy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON23616

Enrollment

Registered

2016-04-06

Start date

2016-05-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biochemical recurrent Prostate Cancer, post-radiotherapy, functional imaging. Biochemisch recidief prostaatkanker, na radiotherapie, functionele beeldvorming

Interventions

68Ga-PSMA PET/CT and a 18F-FDHT PET/CT

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion criteria In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Histologically proven prostate cancer for which the subject has undergone radiotherapy with curative intent - Biochemical recurrence according to Phoenix criteria (PSA nadir +2 ng/mL) - PSA <10 ng/mL - Written informed consent - No androgen deprivation therapy in the past 12 months

Exclusion criteria

Exclusion criteria: - Active cancer besides prostate cancer - Suspected metastases - PSA > 10 ng/mL - Androgen deprivation therapy in the past 12 months - Any contra-indications for undergoing a MRI scan, i.e. metal-containing implants such as pacemaker, defibrillator or wires in the body and metal particles in the eye.

Design outcomes

Primary

Measure	Time frame
Main study parameter/endpoints - Visual assessment of number of lesions en conclusion of re-staging (localized disease, systemic disease or a combination of the two) according to 68 Ga-PMSA PET/CT and 18 F-FDHT PET/CT on patient-by-patient basis. - Semi-quantitative lesion by lesion comparison of tracers by measuring and evaluating the maximum and mean standardized uptake value (SUVmax , SUVmean)	—

Secondary

Measure	Time frame
Secondary study parameters/endpoints Lesion-based analysis by comparing the number of detected lesions in different sites of recurrence/metastases with PSMA PET/CT and also for FDHT PET/CT with lesions detected by mMRI and information from follow-up (PSA response to salvage therapy, confirmative biopsy or lymph node dissection and other imaging studies (X-ray, bone scans)). To assess the overall accuracy, sensitivity, specificity, PPV (positive predictive value) and NPV (negative predictive value) per imaging modality.	—

Measure

Time frame

Secondary study parameters/endpoints Lesion-based analysis by comparing the number of detected lesions in different sites of recurrence/metastases with PSMA PET/CT and also for FDHT PET/CT with lesions detected by mMRI and information from follow-up (PSA response to salvage therapy, confirmative biopsy or lymph node dissection and other imaging studies (X-ray, bone scans)). To assess the overall accuracy, sensitivity, specificity, PPV (positive predictive value) and NPV (negative predictive value) per imaging modality.

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Contacts

Public ContactMarleen Vallinga

Hanzeplein 1 afdeling Urologie

tel 0506319952

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)