NCT04024475Fut, nem toboroz
Prostate Cancer Biobank
Prospective Cohort Study With Collection of Clinical Data, Serum and Plasma of Patients With Prostate Disease
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2022. jún. 8.
Rövid összefoglaló (regiszter, angolul)
Carcinoma of the prostate is the second most commonly diagnosed cancer and occurs predominantly in older men - almost two-thirds of those affected are over 65 years of age. In a significant proportion of patients, the disease is harmless and progresses only very slowly. As a result, there is a risk of overdiagnosis and overtreatment. The main diagnostic tool for prostate cancer is the prostate-specific antigen (PSA) test, but its specificity is minimal. It is important to look for other biological characteristics (biomarkers) that provide pointers to the need for a diagnosis and treatment. Even after treatment and in advanced stages of disease, decisions are often difficult, because it is not necessarily clear which patient needs a specific treatment. In this study, a multicenter biobank of patient sera, plasma and tissue is being established together with information of relevance to the disease, in order to provide a basis for the testing of biomarkers. The aim is to identify markers that offer diagnostic and treatment-selective pointers and thus make a decisive contribution to the optimum care of patients.
- Állapot (regiszter)
- Fut, nem toboroz
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 1323 (tényleges)
- Első benyújtás
- 2019. júl. 11.
- Kezdés
- 2014. nov. 4.
- Elsődleges befejezés
- 2022. dec.
- Fő szponzor
- Swiss Cancer Institute
- Betegségek
- Prosztatarák
- NCT-szám
- NCT04024475
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Bevont résztvevők: 1323
- 2014. nov. 4. és az elsődleges befejezés (2022. dec.) között
- 12 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- Other concurrent active malignancy.
Más betegség
- Psychiatric disorder precluding understanding of information on study related topics and giving informed consent.
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the trial protocol and follow-up.
Kiket keres a vizsgálat
- Written informed consent for storage of liquid samples and referencing of biopsy(-ies) in the biobank, and for clinicopathological data collection, for translational research purposes.
- Criteria for entering diagnostic group A
- Patient scheduled for prostate biopsy for any reason
- Criteria for entering group B
- Subgroup B0 (active surveillance, closed group):
- Patient under active surveillance for localized PCa
- All of the following criteria should be fulfilled:
- clinical stage T1/T2
- PSA ≤ 10 ng/ml
- PSA density \< 0.2 ng/ml per milliliter
- biopsy Gleason score ≤ 6
- one or two positive biopsy cores
- Subgroups B1-B3 (treatment with curative intent):
- Patient under treatment for localized PCa with either radical prostatectomy or RP followed by (adjuvant) external beam radiation (B1), or external beam radiation therapy without (B2) or with ADT (B3).
- Criteria for entering diagnostic group C
- Patient underwent RP
- Patient with biochemical relapse: PSA progression after RP is defined as two consecutive rises with final PSA value \> 0.1 ng/mL, or three consecutive rises (the first value must be measured earliest 4 weeks after radical prostatectomy).
- Patient is candidate for salvage RT with or without combined systemic therapy.
- Criteria for entering diagnostic group D
- Metastatic PCa without curatively intended treatment, but hormone sensitive disease, treated with ADT (medical or surgical) with or without additive treatments, such as docetaxel or short term course of Bicalutamide or continuous Bicalutamide.
- Oligometastatic PCa: N1 or M1a/b disease detected on PET or whole body MRI presenting ≤5 synchronous lesions (bone and/or lymph nodes), under active surveillance, or treated with chemotherapy, treated with focal RT (i.e. SBRT), treated with surgery or other treatments; ADT can be combined, but it is not necessarily required for oligometastatic patients.
- Criteria for entering diagnostic group E (metastatic castration resistant PCa)
- Patient with mCRPC defined by: progressive disease after surgical castration or under medical ADT and suppressed testosterone levels.
- Oligometastatic PCa: N1 or M1a/b disease detected on PET or whole body MRI presenting ≤5 synchronous lesions (bone and/or lymph nodes), under active surveillance, or treated with chemotherapy, treated with focal RT (i.e. SBRT), treated with surgery or other treatments; ADT can be combined, but it is not necessarily required for oligometastatic patients.
Életkor a regiszterben: 18 év – 70 év · Nem: csak férfiak · Egészséges önkénteseket nem fogad
Helyszínek (12)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.