Prostate Cancer Biobank

NCT ID: NCT04024475

Last Updated: 2022-06-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 1323 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-11-04
• Study Completion Date: 2029-11-30

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 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.

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 slow-growing and harmless. This highlights one of the major issues with PCa screening and diagnosis: the risks of over-detection and overtreatment, i.e. to diagnose and invasively treat indolent cancers that may lead to reduced quality of life without increasing overall survival.

The main diagnostic tool for PCa is the systematic screening for PSA (prostate-specific antigen), despite the low specificity of PSA and the unclear cut-off value, resulting in a large proportion of unnecessary biopsies with potential side effects. Additionally, as screening addresses a healthy population and screened men may suffer from disadvantages, such as unnecessary biopsies, screening in PCa remains controversial.

Besides the dilemmas in PCa screening, there are several additional important clinical questions that deserve further investigation and better risk-adapted patient stratification as follows: 1) active treatment versus deferred therapy in the heterogeneous group of patients with localized PCa; 2) treatment intensification for locally-advanced, high-risk prostate cancers with significant risk of PCa-related deaths; 3) optimal approach for patients with high risk of local recurrence post-radical prostatectomy; 4) treatment of patients with rising PSA (biochemical relapse) after curative treatment (either radical prostatectomy or RT); 5) a better understanding of oligometastatic disease and; and 6) treatment of patients with castration-resistant prostate cancer (CRPC).

PCa is characterized by a wide spectrum of molecular and phenotypic characteristics. PCa patients are currently grouped in different risk categories, illustrating particular features of a heterogeneous disease. On one side, many patients present benign disease, such as benign prostate enlargement caused by prostate hyperplasia and, on the other side, progressively malignant PCa, ranging from localized, locally-advanced, metastatic and castrate-resistant disease.

For the purpose of this study, we established 5 groups and their corresponding subgroups, as follows:

A) Opportunistic screening and benign prostate syndrome (BPS) with prostate biopsy; B) Localized and locally advanced prostate cancers treated with curative intent; C) Biochemical relapse after RP; D) Metastatic advanced PCa without curative treatment but hormone sensitive disease, treated with ADT (medical or surgical); E) Metastatic castration resistant prostate cancer (mCRPC).

Currently a comprehensive biobank in the field of urogenital disease, driven by a multidisciplinary panel (composed by specialists from the following fields: urology, medical oncology, radio-oncology and pathology), does not exist in Switzerland.

Such biobank (together with the corresponding clinical data) would enable researchers and clinicians alike to discover and validate diagnostic, prognostic and predictive PCa biomarkers, which are currently highly needed.

Importantly, the biobank shall consist of specific sample sets related to the different stages of PCa development (including screened healthy men and newly diagnosed patients). Ultimately, this comprehensive project will allow addressing some of the urgent questions in different stages of PCa.

Objective:

To create a novel and comprehensive plasma and serum biobank of about 55000 samples (derived from about 1540 patients) accompanied by the corresponding clinical data. This will enable us to explore and validate different diagnostic, prognostic and predictive biomarkers regarding prostate disease.

Conditions

Prostatic Neoplasms

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

A: Opportunistic screening & benign prostate syndrome (BPS)

Asymptomatic men offered screening (PSA testing) with prostate biopsy (A1). Or patients with lower urinary tract symptoms from benign prostatic hyperplasia undergoing: no treatment (A2), medical therapy (A3), or transurethral resection of the prostate (A4)

Observation

Intervention Type: OTHER

B: Localized/locally advanced PCa with curative intent

B0: Patients under active surveillance (B0, closed group); B1: radical prostatectomy (RP) or RP followed by (adjuvant) external beam radiation; B2: external beam radiation therapy (EBRT) without androgen deprivation therapy (ADT); B3: external beam radiation therapy with ADT

Observation

Intervention Type: OTHER

C: Biochemical relapse

Patients with PSA progression after RP with or without systemic therapy

Observation

Intervention Type: OTHER

D: Metastatic PCa but hormone sensitive

Metastatic PCa without curative treatment but hormone sensitive disease, treated with ADT (medical or surgical), with or without additive treatments. Oligometastatic PCa.

Observation

Intervention Type: OTHER

E: Metastatic castration resistant prostate cancer (mCRPC)

Metastatic castration resistant prostate cancer (mCRPC). Oligometastatic PCa.

Observation

Intervention Type: OTHER

Interventions

Observation

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

ProteoMediX AG

INDUSTRY

Sponsor Role: collaborator

Cantonal Hospital of St. Gallen

OTHER

Sponsor Role: collaborator

Swiss Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel Engeler, MD

Role: STUDY_CHAIR

Cantonal Hospital of St. Gallen

Locations

Kantonsspital Baden

Baden, , Switzerland

Universitaetsspital-Basel

Basel, , Switzerland

Inselspital Bern

Bern, , Switzerland

Spitalzentrum Biel

Biel, , Switzerland

Kantonsspital Graubuenden

Chur, , Switzerland

Hopital Fribourgeois HFR

Fribourg, , Switzerland

Hôpitaux Universitaires Genève HUG

Geneva, , Switzerland

Luzerner Kantonsspital

Lucerne, , Switzerland

Clinica Luganese

Lugano, , Switzerland

Kantonsspital Olten

Olten, , Switzerland

Kantonsspital St. Gallen

Sankt Gallen, , Switzerland

Spital STS AG

Thun, , Switzerland

Countries

Switzerland

Other Identifiers

SAKK 63/12

Identifier Type: -

Identifier Source: org_study_id