Prospective Cohort Study With Collection of Clinical Data, Serum and Plasma of Patients With Prostate Disease
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Prostatic Neoplasms
- Sponsor
- Swiss Group for Clinical Cancer Research
- Enrollment
- 1323
- Locations
- 12
- Primary Endpoint
- Group A: Time to prostate cancer (PCa) histological diagnosis
- Status
- Active, Not Recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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
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.
Group B2-B3: Interval to biochemical failure (IBF)
Time Frame: At 18 months after assigned into Group B2-B3
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.
Group B0: Progression free survival (PFS)
Time Frame: At 1 year after assigned into Group B0
PFS will be calculated from the time when patients were assigned into group B0 until first documented event occurred: * three or more positive cores at rebiopsy * Gleason score ≥ 7 at rebiopsy
Group B1: Biochemical relapse free survival
Time Frame: At 5 years after assigned into Group B1
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).
Group C: Progression free survival (PFS)
Time Frame: At progression or latest 10 years after assigned into Group C
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.
Group E: Overall survival (OS)
Time Frame: At death or latest 10 years after assigned into Group E
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: * the patient is lost to follow-up * or death is not experienced.
Group D: Biochmical prostate specific antigen progression
Time Frame: At 6 months after induction of androgen deprivation therapy
The biochemical prostate specific antigen (PSA) progression is calculated from the induction of palliative androgen deprivation therapy (ADT), defined as: * In case PSA levels had not decreased from baseline, under treatment: ≥ 25% increase from baseline (last PSA measurement before treatment start) AND an increase in the absolute PSA value of ≥ 2 ng/mL and presence of castrate level of testosterone. * In case PSA levels decreased from baseline, under treatment: ≥ 25% increase above the nadir AND an increase in the absolute PSA value of ≥ 2 ng/mL and presence of castrate level of testosterone.
Secondary Outcomes
- Group A, B0-B3, C, D: Overall survival (OS)(At death from any cause or latest 10 years after assigned into the corresponding Group)
- Group B0: Progression free survival (PFS)(At the occurrence of the event or latest 10 year after assigned into Group B0)
- Group B0: Event free survival (EFS)(At the occurrence of the event or latest 10 year after assigned into Group B0)
- Group D: Progression free survival (PFS)(At the occurrence of the event or latest 10 year after assigned into Group D)
- Group E: Progression free survival (PFS)(At the occurrence of the event or latest 10 year after assigned into Group E)
- Group A, B1-B3, C: Time to PCa-specific death(At prostate cancer related death or latest 10 years after assigned into the corresponding Group)