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Prostate Cancer Biobank

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ClinicalTrials.gov Identifier: NCT04024475
Recruitment Status : Recruiting
First Posted : July 18, 2019
Last Update Posted : July 18, 2019
Sponsor:
Collaborators:
ProteoMediX AG
Cantonal Hospital of St. Gallen
Information provided by (Responsible Party):
Swiss Group for Clinical Cancer Research

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.


Condition or disease Intervention/treatment
Prostatic Neoplasms Other: Observation

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1540 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 2019
Estimated Study Completion Date : November 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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)
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
Other: Observation
C: Biochemical relapse
Patients with PSA progression after RP with or without systemic therapy
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.
Other: Observation
E: Metastatic castration resistant prostate cancer (mCRPC)
Metastatic castration resistant prostate cancer (mCRPC). Oligometastatic PCa.
Other: Observation



Primary Outcome Measures :
  1. 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.

  2. 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

  3. 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).

  4. 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.

  5. 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.

  6. 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.

  7. 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.


Secondary Outcome Measures :
  1. 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 ]

    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:

    • the patient is lost to follow-up
    • or death is not experienced.

  2. 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 ]
    Time to PCa-specific death is calculated from the time when patients were assigned into the group until death due to cancer occurs.

  3. Group B0: Progression free survival (PFS) [ Time Frame: At the occurrence of the event or latest 10 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
    • after follow-up ≥ 1 year: PSA doubling time <3 years

  4. Group B0: Event free survival (EFS) [ Time Frame: At the occurrence of the event or latest 10 year after assigned into Group B0 ]

    EFS will be calculated from the time when patients were assigned into group B0 until documented events, whichever occurs first:

    • Any criteria defining PFS, and in addition the following ones:
    • transurethral resection
    • RP with curative intent
    • RT with curative intent
    • start of androgen deprivation therapy (ADT)

  5. Group D: Progression free survival (PFS) [ Time Frame: At the occurrence of the event or latest 10 year after assigned into Group D ]

    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:

    • Biochemical PSA progression
    • Progression of metastatic disease
    • symptomatic clinical progression
    • death

  6. Group E: Progression free survival (PFS) [ Time Frame: At the occurrence of the event or latest 10 year after assigned into Group E ]
    PFS will be calculated from the time when patients were assigned into group E until disease progression or death.


Biospecimen Retention:   Samples Without DNA
Serum, plasma, and buffy coat samples; Prostate biopsies


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
Study Population
See description under "Groups/Cohorts"
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04024475


Contacts
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Contact: Anette van Dorland, PhD +41 31 389 91 91 trials@sakk.ch

Locations
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Switzerland
Kantonsspital Baden Recruiting
Baden, Switzerland, 5404
Contact: Konstantinos Tyriakidis, MD    +41 56 486 34 11      
Contact       konstantinos.tyriakidis@ksb.ch   
Principal Investigator: Konstantinos Tyriakidis, MD         
Universitaetsspital-Basel Recruiting
Basel, Switzerland, 4031
Contact: Cyrill A. Rentsch, MD    +41 61 556 54 77    cyrill.rentsch@usb.ch   
Principal Investigator: Cyrill A. Rentsch, MD         
Inselspital Bern Recruiting
Bern, Switzerland, CH-3010
Contact: Daniel M. Aebersold, Prof    +41 31 632 24 31    daniel.aebersold@insel.ch   
Principal Investigator: Daniel M. Aebersold, Prof         
Spitalzentrum Biel Recruiting
Biel, Switzerland, CH-2501
Contact: Martin Zweifel, MD    +41 32 324 36 62    martin.zweifel@szb-chb.ch   
Principal Investigator: Martin Zweifel, MD         
Kantonsspital Graubuenden Recruiting
Chur, Switzerland, 7000
Contact: Räto Strebel, MD    +41 81 256 62 37    raeto.strebel@ksgr.ch   
Principal Investigator: Räto Strebel, MD         
Hopital Fribourgeois HFR Recruiting
Fribourg, Switzerland, 1708
Contact: Daniel Betticher, Prof    +41 26 426 72 40    daniel.betticher@h-fr.ch   
Principal Investigator: Daniel Betticher, Prof         
Hôpitaux Universitaires Genève HUG Recruiting
Geneva, Switzerland, 1211
Contact: Thomas Zilli, MD    +41 22 372 70 90    thomas.zilli@hcuge.ch   
Principal Investigator: Thomas Zilli, MD         
Clinica Luganese Recruiting
Lugano, Switzerland, 6900
Contact: Franzetti Pellanda Franzetti Pellanda, MD    +41 91 960 81 31    alessandra.franzetti-pellanda@clinicaluganese.ch   
Principal Investigator: Franzetti Pellanda Franzetti Pellanda, MD         
Luzerner Kantonsspital Recruiting
Luzern, Switzerland, 6000
Contact: Agostino Mattei, MD    +41 41 205 45 16    agostino.mattei@luks.ch   
Principal Investigator: Agostino Mattei, MD         
Kantonsspital Olten Recruiting
Olten, Switzerland, 4600
Contact: Peter Spörri, MD    +41 62 311 42 83    peter.spoerri@spital.so.ch   
Principal Investigator: Peter Spörri, MD         
Kantonsspital St. Gallen Recruiting
St. Gallen, Switzerland, 9007
Contact: Daniel Engeler, MD    +41 71 494 14 30    daniel.engeler@kssg.ch   
Principal Investigator: Daniel Engeler, MD         
Spital STS AG Recruiting
Thun, Switzerland, 3600
Contact: Daniel Rauch, MD    +41 58 636 22 27    daniel.rauch@spitalstsag.ch   
Principal Investigator: Daniel Rauch, MD         
Sponsors and Collaborators
Swiss Group for Clinical Cancer Research
ProteoMediX AG
Cantonal Hospital of St. Gallen
Investigators
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Study Chair: Daniel Engeler, MD Cantonal Hospital of St. Gallen

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Responsible Party: Swiss Group for Clinical Cancer Research
ClinicalTrials.gov Identifier: NCT04024475     History of Changes
Other Study ID Numbers: SAKK 63/12
First Posted: July 18, 2019    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data may be shared on reasonable request, after internal and ethical approval
URL: http://sakk.ch

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Swiss Group for Clinical Cancer Research:
Radical prostatectomy
Metastatic castration resistant prostate cancer
Oligometastatic prostate cancer
Radiotherapy
Prostate cancer screening
Prostate-specific antigen (PSA)
Prostate cancer (PCa)
Opportunistic screening

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases