18F-FDHT PET/CT for re-staging patients with recurrent of prostate cancer after radiotherapy; a pilot study

18F-FDHT PET/CT for re-staging patients with recurrent of prostate cancer after radiotherapy; a pilot study - FDHT PET/CT for restaging recurrent prostate cancer

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON43219

Enrollment

Registered

2016-11-14

Start date

2018-01-19

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

prostate cancer recurrent

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion criteria: - Active cancer besides prostate cancer - Suspected metastases - PSA > 10 ng/mL - Androgen deprivation therapy in the past 12 months - A contra-indication for undergoing MRI. (namely implants containing metal or metal schrapnels in the eyes or body and claustrophobia)

Design outcomes

Primary

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

Secondary

Measure	Time frame
Lesion-based analysis by comparing the number of detected lesions in different sites of recurrence/metastases with FDHT PET/CT to PSMA PET/CT and 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) of 18 F-FDHT PET/CT.	—

Measure

Time frame

Lesion-based analysis by comparing the number of detected lesions in different sites of recurrence/metastases with FDHT PET/CT to PSMA PET/CT and 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) of 18 F-FDHT PET/CT.

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Countries

Netherlands

Outcome results