Content - SAKK 63/12

SAKK 63/12 - Study on the exploration and validation of biomarkers for prostate cancer in a biobank

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 multicentre biobank of patient sera 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.

Study Chair:

Dr. med. Daniel Engeler, Cantonal Hospital of St.Gallen, +41 71 494 14 30

  • Contacts at the hospitals

  • Inclusion criteria

    Criteria for entering diagnostic group A (Opportunistic screening and benign prostate syndrome with prostate biopsy)

    • Male patient between 18 and 70 years old.

    • Patient must give written informed consent, before registration, for storage of sera and referencing of his biopsy (-ies) in the biobank, and for clinicopathological data collection, for translational research purposes.

    • Patient scheduled for prostate biopsy for any reason

    Criteria for entering diagnostic group B (localized/locally advanced prostate cancer managed/treated with curative intent)

    Subgroup B0 (active surveillance):

    • Male patient 18 years or older.

    • Patient must give written informed consent, before registration, for storage of sera and referencing of his biopsy (-ies) in the biobank, and for clinicopathological data collection, for translational research purposes.

    • Patient planned to be under active surveillance for localized prostate cancer

    • All of the following criteria (according to the PRIAS study [26]) 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)

    • Male patient 18 years or older.

    • Patient must give written informed consent, before registration, for storage of sera and referencing of his biopsy (-ies) in the biobank, and for clinicopathological data collection, for translational research purposes.

    • Patient planned to receive treatment for localized prostate cancer with either radical prostatectomy (B1), or external beam radiation therapy without (B2) or with ADT (B3)

    Criteria for entering diagnostic group C (biochemical relapse after curative treatment with RP)

    • Male patient 18 years or older

    • Patient must give written informed consent, before registration, for storage of sera and referencing of his biopsy (-ies) in the biobank, and for clinicopathological data collection, for translational research purposes.

    • Patient underwent RP

    • Patient with biochemical relapse:

    • PSA progression after RP is defined as two consecutive rises with the 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

    Criteria for entering diagnostic group D (metastatic prostate cancer without curative treatment but hormone sensitive disease, treated with ADT)

    • Male patient 18 years or older

    • Patient must give written informed consent, before registration, for storage of sera and referencing of his biopsy (-ies) in the biobank, and for clinicopathological data collection, for translational research purposes.

    • Metastatic prostate cancer without curative treatment but hormone sensitive disease, planned to be treated with ADT (medical or surgical)

    Criteria for entering diagnostic group E (metastatic castration resistant prostate cancer)

    • Male patient 18 years or older

    • Patient must give written informed consent, before registration, for storage of sera and referencing of his biopsy (-ies) in the biobank, and for clinicopathological data collection, for translational research purposes.

    • Patient with mCRPC defined by:

      • total testosterone ≤ 50 ng/dl (≤ 1.7 nmol/l)

      • ongoing medical castration (if not surgically castrated)

      • progressive disease defined as radiological progression or PSA progression

  • 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.

Locations for this trial:

Kantonsspital Baden
Im Ergel 1
4600 Baden
Universitätsspital Basel
Petersgraben 4
0 4031 Basel
Inselspital
Freiburgstrasse 8
3010 Bern
Spitalzentrum Biel
Vogelsang 84
0 2501 Biel
Kantonsspital Graubünden
Loëstrasse 170
7000 Chur
Hôpital Fribourgeois HFR
Chemin des Pensionnats 2
1708 1708 Fribourg
Hôpitaux Universitaires de Genève HUG
Rue Gabrielle-Perret-Gentil 4
0 1205 Genève
Ospedale Civico
Via Tesserete 46
0 6900 Lugano
Kantonsspital Luzern
Spitalstrasse
0 6000 Luzern
Kantonsspital St. Gallen
Rorschacher Strasse 95
0 9007 St. Gallen