Clinical study for the detection of prostate cancer lesions using F-18-PSMA-1007 PET (Positron Emission Tomography)
Zusammenfassung der Studie
In prostate cancer patients, an increase in the PSA (Prostate-Specific Antigen) blood level after prior prostate cancer treatment may be a sign of tumor recurrence. To localize the tumor, imaging procedures (such as computed tomography [CT], magnetic resonance imaging [MRI], or positron emission tomography [PET]) are routinely performed. In PET, radioactively labeled biomolecules, known as tracers, are used to visualize metabolic processes. In our research project, we want to find out how well the tracer F-18-PSMA-1007 detects prostate cancer lesions during a PET scan.
(BASEC)
Untersuchte Intervention
For this study, the patient must undergo 4 to 5 visits within 6 months.
During the first visit, patient data and medical history are recorded, and a blood and urine sample is taken to assess the patient's health status. The patient receives an injection of the tracer F-18-PSMA-1007 during the second visit, and a PET scan is performed. An ECG and vital signs are recorded before and after the injection / PET scan. Visit 3 takes place one day after visit 2, and blood and urine samples are again collected for a safety check. Some patients are invited to visit 4, during which either an MRI examination or a biopsy is performed. Whether a visit 4 is necessary for the patient depends on the stage of the prostate cancer and the results of the F-18-PSMA-1007 PET examination. The final visit, 6 months after the PET scan, is then necessary for all patients; here, further patient data on the disease progression since the start of the study is collected.
(BASEC)
Untersuchte Krankheit(en)
Prostate cancer
(BASEC)
Men diagnosed with prostate cancer can participate in the study. The prostate cancer has already been targeted treated, and there is suspicion of recurrence as the PSA blood level has increased again despite treatment. (BASEC)
Ausschlusskriterien
Patients whose health status is not stable cannot participate. If they cannot tolerate the tracer F-18-PSMA-1007 in any way, they are excluded from the study. Other exclusion reasons include the inability to undergo a PET scan (e.g., due to severe obesity or claustrophobia) or participation in other clinical trials. (BASEC)
Studienstandort
Bern
(BASEC)
Sponsor
ABX advanced biochemical compounds Radeberg, Germany Silvia Dotti-Sigrist Bottmingen Switzerland
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Ali Afshar-Oromieh
+41 31 632 36 55
ali.afshar@clutterinsel.chInselspital, Universitätsspital Bern Universitätsklinik für Nuklearmedizin Rosenbühlgasse 25 CH-3010 Bern
(BASEC)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Bern
(BASEC)
Datum der Bewilligung durch die Ethikkommission
13.07.2021
(BASEC)
ICTRP Studien-ID
NCT04742361 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
Phase III study of [18F]PSMA-1007 positron emission tomography for the detection of prostate cancer lesions in patients with biochemical recurrence after previous definitive treatment for localized prostate cancer (BASEC)
Wissenschaftlicher Titel
Phase III Study of [18F]PSMA-1007 Positron Emission Tomography for the Detection of Prostate Cancer Lesions in Patients With Biochemical Recurrence After Previous Definitive Treatment for Localized Prostate Cancer (ICTRP)
Öffentlicher Titel
Efficacy of [18F]PSMA-1007 PET/CT in Patients With Biochemial Recurrent Prostate Cancer (ICTRP)
Untersuchte Krankheit(en)
Prostate CancerProstate Cancer Recurrent (ICTRP)
Untersuchte Intervention
Drug: [18F]PSMA-1007 (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label). (ICTRP)
Ein-/Ausschlusskriterien
Inclusion Criteria:
- Male with original diagnosis of adenocarcinoma of the prostate with prior definitive
therapy
- Suspicion of recurrence or persistence
- after radiotherapy or cryotherapy: 3 consecutive PSA rises and/or PSA rise by
2.0 ng/mL or more above nadir (ASTRO-Phoenix)
- after prostatectomy, PSA > 0.2 ng/mL on 2 or more determinations (recurrence),
or failure of PSA to fall to undetectable levels post-prostatectomy
(persistence) (American Urological Association)
- For patients who previously had radical prostatectomy, salvage radiotherapy is one
likely treatment plan for patients who initially underwent radiotherapy (including
brachytherapy), confirmation of low volume disease is needed to define (local)
treatment.
- Life expectancy of 6 months or more as judged by the investigator
- Willing and able to undergo all study procedures
- Informed consent in writing
Exclusion Criteria:
- Age: less than18 years
- Contraindications to any of the ingredients of [18F]PSMA-1007
- Close affiliation with the investigational site
- At the time of enrolment into this study, participating in another therapeutic
clinical trial or has completed study participation in another therapeutic clinical
trial within 5 days of enrolment into this trial
- Having been previously enrolled in this clinical trial
- Mental conditions rendering the subject incapable to understand the nature, scope,
and consequences of the trial
- Being clinically unstable or requiring emergency treatment
- Patients who are unwilling to consider a biopsy if clinically recommended
- Patients who are unable to undergo a PET/CT scan
- Patients for whom systemic therapy is the most likely course regardless of PET
findings. (ICTRP)
nicht verfügbar
Primäre und sekundäre Endpunkte
Region-level positive predictive value (PPV) of [18F]PSMA-1007 using a combined standard of truth (SOT);Patient-level correct detection rate of [18F]PSMA-1007 (ICTRP)
nicht verfügbar
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
Alexander Hoepping, Dr., hoepping@abx.de, +49 3528 4041 60 (ICTRP)
Sekundäre IDs
ABX-CT-303 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/study/NCT04742361 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
laymens-studienreport-summary-ch-20250207.pdfLink zu den Ergebnissen im Primärregister
nicht verfügbar