search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


PSMA vs. FDHT PET/CT for restaging recurrent prostate cancer


- candidate number24199
- NTR NumberNTR5790
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-apr-2016
- Secondary IDs56762 ABR nr
- Public TitlePSMA vs. FDHT PET/CT for restaging recurrent prostate cancer
- Scientific TitleComparison of 68Ga-PSMA PET/CT with 18F-FDHT PET/CT for re-staging patients with recurrent prostate cancer after radiotherapy
- ACRONYMPaFe
- hypothesisStudies on PSMA PET/CT the past few years are promising but often of retrospective nature and with heterogeneous patient populations. 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 both PET/CT scans.
- Healt Condition(s) or Problem(s) studiedProstate cancer, Relapse
- Inclusion criteriaInclusion criteria
In order to be eligible to participate in this study, a subject must meet all of the following 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
- Exclusion criteria- Active cancer besides prostate cancer
- Suspected metastases
- PSA > 10 ng/mL
- Androgen deprivation therapy in the past 12 months
- Any contra-indications for undergoing a MRI scan, i.e. metal-containing implants such as pacemaker, defibrillator or wires in the body and metal particles in the eye.
- mec approval receivedno
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeintervention
- planned startdate 1-mei-2016
- planned closingdate31-dec-2017
- Target number of participants20
- Interventions68Ga-PSMA PET/CT and a 18F-FDHT PET/CT
- Primary outcomeMain study parameter/endpoints
- Visual assessment of number of lesions en conclusion of re-staging (localized disease, systemic disease or a combination of the two) according to 68 Ga-PMSA PET/CT and 18 F-FDHT PET/CT on patient-by-patient basis.
- Semi-quantitative lesion by lesion comparison of tracers by measuring and evaluating the maximum and mean standardized uptake value (SUVmax , SUVmean)
- Secondary outcomeSecondary study parameters/endpoints
Lesion-based analysis by comparing the number of detected lesions in different sites of recurrence/metastases with PSMA PET/CT and also for FDHT PET/CT 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) per imaging modality.
- Timepoints1 timepoint, with 2 scans close to each other
- Trial web sitenot applicable
- 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)
- Publicationsnot applicable
- Brief summaryRationale: 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 11 C-choline PET/CT, but has a moderate sensitivity rate and is least accurate in low PSA ranges, while that is exactly the range in which salvage treatment was shown to be most effective. Studies on PSMA PET/CT the past few years are promising but often of retrospective nature and with heterogeneous patient populations. 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 both PET/CT scans.

Objective: to compare the value (i.e. detection rate) of 68 Ga-PMSA PET/CT with 18 F-FDHT PET/CT and evaluate the accuracy of both tracers.

Study design: A pilot prospective comparative imaging study. Only one point of measurement, where three scans will take place.

Study population: 20 men with biochemical recurrent prostate cancer after radiotherapy who are candidates for local salvage treatment.

Main study parameters/endpoints:
Primary:
- visual assessment of number of lesions en conclusion of re-staging (localized disease, systemic disease or a combination of the two) according to 68 Ga-PMSA PET/CT and 18 F-FDHT PET/CT on patient-by-patient basis.
- Semi-quantitative lesion by lesion comparison of tracers by measuring and evaluating the maximum and mean standardized uptake value (SUVmax , SUVmean)
Secondary:
Lesion-based analysis by comparing the detected lesions in different sites of recurrence/metastases 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 overall accuracy, sensitivity, specificity, PPV and NPV per imaging modality
- Main changes (audit trail)
- RECORD6-apr-2016 - 28-mei-2016


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl