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

Recruiting

Conditions: prostate cancer
recurrent
10038597
10036958

Registration Number: NL-OMON43219

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 20

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 <10 ng/mL
- Written informed consent
- No androgen deprivation therapy in the past 12 months
- Planned for restaging or patients who have recently have been restaged with a mpMRI and 68 Ga-PSMA PET/CT (last scan not more than 28 days ago)

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)

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
<p>Lesion-based analysis by comparing the number of detected lesions in different<br /><br>sites of recurrence/metastases with FDHT PET/CT to PSMA PET/CT and with<br /><br>lesions detected by mMRI and information from follow-up (PSA response to<br /><br>salvage therapy, confirmative biopsy or lymph node dissection and other imaging<br /><br>studies (X-ray, bone scans)). To assess the overall accuracy, sensitivity,<br /><br>specificity, PPV (positive predictive value) and NPV (negative predictive<br /><br>value) of 18 F-FDHT PET/CT.</p><br>