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.
Condition or disease | Intervention/treatment |
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Prostatic Neoplasms | Other: Observation |
Study Type : | Observational [Patient Registry] |
Actual Enrollment : | 1323 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 10 Years |
Official Title: | Prospective Cohort Study With Collection of Clinical Data, Serum and Plasma of Patients With Prostate Disease |
Actual Study Start Date : | November 4, 2014 |
Estimated Primary Completion Date : | December 2022 |
Estimated Study Completion Date : | November 2029 |
Group/Cohort | Intervention/treatment |
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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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Other: Observation |
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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Other: Observation |
C: Biochemical relapse
Patients with PSA progression after RP with or without systemic therapy
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Other: Observation |
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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Other: Observation |
E: Metastatic castration resistant prostate cancer (mCRPC)
Metastatic castration resistant prostate cancer (mCRPC). Oligometastatic PCa.
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Other: Observation |
PFS will be calculated from the time when patients were assigned into group B0 until first documented event occurred:
The biochemical prostate specific antigen (PSA) progression is calculated from the induction of palliative androgen deprivation therapy (ADT), defined as:
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:
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:
PFS will be calculated from the time when patients were assigned into group B0 until first documented event occurred:
EFS will be calculated from the time when patients were assigned into group B0 until documented events, whichever occurs first:
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:
Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
Criteria for entering diagnostic group A
Criteria for entering group B
Subgroup B0 (active surveillance, closed group):
All of the following criteria should be fulfilled:
Subgroups B1-B3 (treatment with curative intent):
Criteria for entering diagnostic group C
Criteria for entering diagnostic group D
Criteria for entering diagnostic group E (metastatic castration resistant PCa)
Exclusion criteria:
Switzerland | |
Kantonsspital Baden | |
Baden, Switzerland, 5404 | |
Universitaetsspital-Basel | |
Basel, Switzerland, 4031 | |
Inselspital Bern | |
Bern, Switzerland, CH-3010 | |
Spitalzentrum Biel | |
Biel, Switzerland, CH-2501 | |
Kantonsspital Graubuenden | |
Chur, Switzerland, 7000 | |
Hopital Fribourgeois HFR | |
Fribourg, Switzerland, 1708 | |
Hôpitaux Universitaires Genève HUG | |
Geneva, Switzerland, 1211 | |
Clinica Luganese | |
Lugano, Switzerland, 6900 | |
Luzerner Kantonsspital | |
Luzern, Switzerland, 6000 | |
Kantonsspital Olten | |
Olten, Switzerland, 4600 | |
Kantonsspital St. Gallen | |
St. Gallen, Switzerland, 9007 | |
Spital STS AG | |
Thun, Switzerland, 3600 |
Study Chair: | Daniel Engeler, MD | Cantonal Hospital of St. Gallen |
Tracking Information | |||||||
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First Submitted Date | July 11, 2019 | ||||||
First Posted Date | July 18, 2019 | ||||||
Last Update Posted Date | June 3, 2021 | ||||||
Actual Study Start Date | November 4, 2014 | ||||||
Estimated Primary Completion Date | December 2022 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures |
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Original Primary Outcome Measures | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title | Prostate Cancer Biobank | ||||||
Official Title | Prospective Cohort Study With Collection of Clinical Data, Serum and Plasma of Patients With Prostate Disease | ||||||
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. |
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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. |
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Study Type | Observational [Patient Registry] | ||||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | 10 Years | ||||||
Biospecimen | Retention: Samples Without DNA Description:
Serum, plasma, and buffy coat samples; Prostate biopsies
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Sampling Method | Probability Sample | ||||||
Study Population | See description under "Groups/Cohorts" | ||||||
Condition | Prostatic Neoplasms | ||||||
Intervention | Other: Observation | ||||||
Study Groups/Cohorts |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status | Active, not recruiting | ||||||
Actual Enrollment |
1323 | ||||||
Original Estimated Enrollment |
1540 | ||||||
Estimated Study Completion Date | November 2029 | ||||||
Estimated Primary Completion Date | December 2022 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria |
Inclusion Criteria:
Criteria for entering diagnostic group A
Criteria for entering group B Subgroup B0 (active surveillance, closed group):
All of the following criteria should be fulfilled:
Subgroups B1-B3 (treatment with curative intent):
Criteria for entering diagnostic group C
Criteria for entering diagnostic group D
Criteria for entering diagnostic group E (metastatic castration resistant PCa)
Exclusion criteria:
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Sex/Gender |
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Ages | 18 Years to 70 Years (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers | No | ||||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries | Switzerland | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number | NCT04024475 | ||||||
Other Study ID Numbers | SAKK 63/12 | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | Swiss Group for Clinical Cancer Research | ||||||
Study Sponsor | Swiss Group for Clinical Cancer Research | ||||||
Collaborators |
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Investigators |
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PRS Account | Swiss Group for Clinical Cancer Research | ||||||
Verification Date | June 2021 |