Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

ACTIVE_NOT_RECRUITING

Prostate Cancer Biobank

Lead Sponsor:

Swiss Cancer Institute

Collaborating Sponsors:

ProteoMediX AG

Cantonal Hospital of St. Gallen

Conditions:

Prostatic Neoplasms

Eligibility:

MALE

18-70 years

Brief Summary

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...

Detailed Description

Background \& Rationale: Prostate Cancer (PCa) occurs mainly in older men, nearly two thirds are diagnosed in men aged 65 or older. However, in a substantial subset of patients, the disease will be s...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • 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.
  • Exclusion criteria:
  • Other concurrent active malignancy.
  • 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.

Exclusion

    Key Trial Info

    Start Date :

    November 4 2014

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    November 1 2029

    Estimated Enrollment :

    1323 Patients enrolled

    Trial Details

    Trial ID

    NCT04024475

    Start Date

    November 4 2014

    End Date

    November 1 2029

    Last Update

    June 8 2022

    Active Locations (12)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 3 (12 locations)

    1

    Kantonsspital Baden

    Baden, Switzerland, 5404

    2

    Universitaetsspital-Basel

    Basel, Switzerland, 4031

    3

    Inselspital Bern

    Bern, Switzerland, CH-3010

    4

    Spitalzentrum Biel

    Biel, Switzerland, CH-2501