to assess the detection rate and accuracy of 18 F-FDHT PET/CT and compare to current standard restaging modalities.
ID
Bron
Verkorte titel
Aandoening
Prostate cancer
Prostaatkanker
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
- 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. <br><br>
- Semi-quantitative lesion assessment of tracer by measuring and evaluating the maximum and mean standardized uptake value (SUVmax, SUVmean)
Achtergrond van het onderzoek
Recurrent 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.
Doel van het onderzoek
to assess the detection rate and accuracy of 18 F-FDHT PET/CT and compare to current standard restaging modalities.
Onderzoeksopzet
1 meetpunt
Onderzoeksproduct en/of interventie
nvt
Algemeen / deelnemers
Marleen Vallinga
Huispostcode CB-62
Groningen 9700 RB
The Netherlands
tel 0506319952
Wetenschappers
Marleen Vallinga
Huispostcode CB-62
Groningen 9700 RB
The Netherlands
tel 0506319952
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
-Anti-androgen treatment in the last 6 months
- other malignancies
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
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Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL6663 |
NTR-old | NTR6841 |
Ander register | METc UMCG // EudraCT number // ABR dossiernummer : 2016.208 // 2016-000533-52 // NL56762.042.16 |