- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04024475
Prostate Cancer Biobank
Prospective Cohort Study With Collection of Clinical Data, Serum and Plasma of Patients With Prostate Disease
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Baden, Switzerland, 5404
- Kantonsspital Baden
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Basel, Switzerland, 4031
- Universitaetsspital-Basel
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Bern, Switzerland, CH-3010
- Inselspital Bern
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Biel, Switzerland, CH-2501
- Spitalzentrum Biel
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Chur, Switzerland, 7000
- Kantonsspital Graubuenden
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Fribourg, Switzerland, 1708
- Hopital Fribourgeois HFR
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Geneva, Switzerland, 1211
- Hôpitaux Universitaires Genève HUG
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Lugano, Switzerland, 6900
- Clinica Luganese
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Luzern, Switzerland, 6000
- Luzerner Kantonsspital
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Olten, Switzerland, 4600
- Kantonsspital Olten
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St. Gallen, Switzerland, 9007
- Kantonsspital St. Gallen
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Thun, Switzerland, 3600
- Spital STS AG
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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)
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|
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
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|
C: Biochemical relapse
Patients with PSA progression after RP with or without systemic therapy
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|
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.
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|
E: Metastatic castration resistant prostate cancer (mCRPC)
Metastatic castration resistant prostate cancer (mCRPC).
Oligometastatic PCa.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Group A: Time to prostate cancer (PCa) histological diagnosis
Time Frame: At the occurrence of a positive biopsy result or latest 10 years after registration
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Time to PCa histological diagnosis will be calculated from the time when patients were assigned into group A until documentation of a positive biopsy result.
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At the occurrence of a positive biopsy result or latest 10 years after registration
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Group B0: Progression free survival (PFS)
Time Frame: At 1 year after assigned into Group B0
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PFS will be calculated from the time when patients were assigned into group B0 until first documented event occurred:
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At 1 year after assigned into Group B0
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Group B1: Biochemical relapse free survival
Time Frame: At 5 years after assigned into Group B1
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Biochemical relapse free survival is calculated from the time when patients were assigned into group B1 until prostate specific antigen (PSA) relapse occurs.
PSA relapse is defined as PSA progression after radical prostatectomy (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 RP).
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At 5 years after assigned into Group B1
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Group B2-B3: Interval to biochemical failure (IBF)
Time Frame: At 18 months after assigned into Group B2-B3
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IBF is defined as the time interval from completion of treatment by patients of group B2 or B3 until biochemical failure (BF).
BF is defined by an absolute PSA value superior or equal to the post-treatment PSA nadir + 2 ng/mL.
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At 18 months after assigned into Group B2-B3
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Group C: Progression free survival (PFS)
Time Frame: At progression or latest 10 years after assigned into Group C
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PFS is counted from the day the patient entered group C to the day of the first record of either local or regional recurrence, distant recurrence, start of hormonal treatment after biochemical failure, or death due to any cause.
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At progression or latest 10 years after assigned into Group C
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Group D: Biochmical prostate specific antigen progression
Time Frame: At 6 months after induction of androgen deprivation therapy
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The biochemical prostate specific antigen (PSA) progression is calculated from the induction of palliative androgen deprivation therapy (ADT), defined as:
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At 6 months after induction of androgen deprivation therapy
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Group E: Overall survival (OS)
Time Frame: At death or latest 10 years after assigned into Group E
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OS will be calculated from the time when patients were assigned into group E until death from any cause. OS will be censored at the time the patient is last known to be alive if:
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At death or latest 10 years after assigned into Group E
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Group A, B0-B3, C, D: Overall survival (OS)
Time Frame: At death from any cause or latest 10 years after assigned into the corresponding Group
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OS will be calculated from the time when patients were assigned into the group until death from any cause. OS will be censored at the time the patient is last known to be alive if:
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At death from any cause or latest 10 years after assigned into the corresponding Group
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Group A, B1-B3, C: Time to PCa-specific death
Time Frame: At prostate cancer related death or latest 10 years after assigned into the corresponding Group
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Time to PCa-specific death is calculated from the time when patients were assigned into the group until death due to cancer occurs.
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At prostate cancer related death or latest 10 years after assigned into the corresponding Group
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Group B0: Progression free survival (PFS)
Time Frame: At the occurrence of the event or latest 10 year after assigned into Group B0
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PFS will be calculated from the time when patients were assigned into group B0 until first documented event occurred:
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At the occurrence of the event or latest 10 year after assigned into Group B0
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Group B0: Event free survival (EFS)
Time Frame: At the occurrence of the event or latest 10 year after assigned into Group B0
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EFS will be calculated from the time when patients were assigned into group B0 until documented events, whichever occurs first:
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At the occurrence of the event or latest 10 year after assigned into Group B0
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Group D: Progression free survival (PFS)
Time Frame: At the occurrence of the event or latest 10 year after assigned into Group D
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PFS is calculated from the time when patients were assigned into group D until documentation of one or any combination of the following events occurred:
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At the occurrence of the event or latest 10 year after assigned into Group D
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Group E: Progression free survival (PFS)
Time Frame: At the occurrence of the event or latest 10 year after assigned into Group E
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PFS will be calculated from the time when patients were assigned into group E until disease progression or death.
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At the occurrence of the event or latest 10 year after assigned into Group E
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Collaborators and Investigators
Investigators
- Study Chair: Daniel Engeler, MD, Cantonal Hospital of St. Gallen
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SAKK 63/12
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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