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FDHT PET/CT for radio-recurrent prostate cancer


- candidate number28211
- NTR NumberNTR6841
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-nov-2017
- Secondary IDs2016.208 // 2016-000533-52 // NL56762.042.16 METc UMCG // EudraCT number // ABR dossiernummer
- Public TitleFDHT PET/CT for radio-recurrent prostate cancer
- Scientific Title18-F-FDHT PET/CT for re-staging patients with recurrent prostate cancer after radiotherapy; a pilot study
- ACRONYMPaFe
- hypothesisto assess the detection rate and accuracy of 18 F-FDHT PET/CT and compare to current standard restaging modalities.
- Healt Condition(s) or Problem(s) studiedProstate cancer
- Inclusion criteriaA 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-Anti-androgen treatment in the last 6 months
- other malignancies
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 20-dec-2017
- planned closingdate1-jul-2019
- Target number of participants20
- Interventionsnvt
- Primary outcome- 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 outcomeLesion-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.
- Timepoints1 meetpunt
- Trial web sitenvt
- statusplanned
- CONTACT FOR PUBLIC QUERIES Marleen Vallinga
- CONTACT for SCIENTIFIC QUERIES Marleen Vallinga
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG)
- Publications
- Brief summaryRecurrent prostate cancer occurs often and is preceded by a rise in PSA (prostate specific antigen). If the rise is more than 2 ng/mL above nadir, this is defined as a biochemical Recurrence (BCR). BCR precedes clinical evident recurrence by years. Restaging with imaging methods is necessary to determine the localisation of recurrence and the adequate treatment. Current restaging is performed with 11C-choline PET/CT or a 68Ga-PSMA PET/CT, Studies on PSMA PET/CT the past few years are very promising and current literature shows that PSMA has a higher detection rate and accuracy than choline in most clinical circumstances (primary vs recurrent and detection of metastases versus local recurrence). In our academic centre there are currently two trials running with 18 F-FDHT PET/CT. Results are promising, but more research is needed to determine exact value of the PET tracer scans. We want to assess if this PET tracer can aid in an optimal selection of patients who are eligible for salvage therapy. So no patients undergo invasive treatment, while they have advanced disease, and therefore undergo unnecessary invasive and possible toxic treatment.
- Main changes (audit trail)
- RECORD17-nov-2017 - 10-dec-2017


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