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FDHT PET/CT for radio-recurrent prostate cancer

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON21317
Enrollment
20
Registered
2017-11-17
Start date
2017-12-20
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

Prostate cancer Prostaatkanker

Interventions

nvt

Sponsors

PI: dr. I.J. de Jong, uroloog. UMCG
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: A prospective observational imaging pilot study. Only one point of measurement, where one scan will take place. Study population: 20 men with biochemical recurrent prostate cancer after radiotherapy who are candidates for local salvage treatment.

Exclusion criteria

Exclusion criteria: -Anti-androgen treatment in the last 6 months - other malignancies

Design outcomes

Primary

MeasureTime 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 assessment of tracer by measuring and evaluating the maximum and mean standardized uptake value (SUVmax, SUVmean)

Secondary

MeasureTime frame
Lesion-based analysis by comparing the detected lesions in different sites of recurrence/metastases with lesions detected by standard imaging by mMRI and PSMA PET/CT 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 overall accuracy, sensitivity, specificity, PPV and NPV.

Contacts

Public ContactMarleen Vallinga

Hanzeplein 1 afdeling Urologie

tel 0506319952

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)