Sign in

NCT04024475Active, not recruiting

Prostate Cancer Biobank

Prospective Cohort Study With Collection of Clinical Data, Serum and Plasma of Patients With Prostate Disease

Source: ClinicalTrials.gov · Last updated 8 Jun 2022

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
1323 (actual)
First submitted
11 Jul 2019
Start date
4 Nov 2014
Primary completion date
31 Dec 2022
Lead sponsor
Swiss Cancer Institute
NCT number
NCT04024475

What you commit to

  • Study type: Observational
  • Participants enrolled: 1323
  • From 4 Nov 2014 to the primary completion date, 31 Dec 2022
  • 12 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Other concurrent active malignancy.

Other illness

  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 70 years · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (12)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Kantonsspital Baden
Coordinator of this site? Confirm its status
BadenSwitzerlandUnknown status
Universitaetsspital Basel
Coordinator of this site? Confirm its status
BaselSwitzerlandUnknown status
Inselspital Bern
Coordinator of this site? Confirm its status
BernSwitzerlandUnknown status
Spitalzentrum Biel
Coordinator of this site? Confirm its status
BielSwitzerlandUnknown status
Kantonsspital Graubuenden
Coordinator of this site? Confirm its status
ChurSwitzerlandUnknown status
Hopital Fribourgeois HFR
Coordinator of this site? Confirm its status
FribourgSwitzerlandUnknown status
Hôpitaux Universitaires Genève HUG
Coordinator of this site? Confirm its status
GenevaSwitzerlandUnknown status
Luzerner Kantonsspital
Coordinator of this site? Confirm its status
LucerneSwitzerlandUnknown status
Clinica Luganese
Coordinator of this site? Confirm its status
LuganoSwitzerlandUnknown status
Kantonsspital Olten
Coordinator of this site? Confirm its status
OltenSwitzerlandUnknown status
Kantonsspital St. Gallen
Coordinator of this site? Confirm its status
Sankt GallenSwitzerlandUnknown status
Spital STS AG
Coordinator of this site? Confirm its status
ThunSwitzerlandUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.