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出境医 / 临床实验 / Prostate Cancer Biobank

Prostate Cancer Biobank

Study Description
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

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Study Design
Layout table for study information
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
Arms 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)
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
Outcome Measures
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

Eligibility Criteria
Layout table for eligibility information
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.
Contacts and Locations

Locations
Layout table for location information
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
Sponsors and Collaborators
Swiss Group for Clinical Cancer Research
ProteoMediX AG
Cantonal Hospital of St. Gallen
Investigators
Layout table for investigator information
Study Chair: Daniel Engeler, MD Cantonal Hospital of St. Gallen
Tracking Information
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
 (submitted: July 16, 2019)
  • 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 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 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 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 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.
  • 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 16, 2019)
  • 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.
  • 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.
  • 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
  • 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)
  • 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
  • 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.
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.

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 Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 10 Years
Biospecimen Retention:   Samples Without DNA
Description:
Serum, plasma, and buffy coat samples; Prostate biopsies
Sampling Method Probability Sample
Study Population See description under "Groups/Cohorts"
Condition Prostatic Neoplasms
Intervention Other: Observation
Study Groups/Cohorts
  • 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)
    Intervention: 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
    Intervention: Other: Observation
  • C: Biochemical relapse
    Patients with PSA progression after RP with or without systemic therapy
    Intervention: 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.
    Intervention: Other: Observation
  • E: Metastatic castration resistant prostate cancer (mCRPC)
    Metastatic castration resistant prostate cancer (mCRPC). Oligometastatic PCa.
    Intervention: Other: Observation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: January 12, 2021)
1323
Original Estimated Enrollment
 (submitted: July 16, 2019)
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:

  • 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.
Sex/Gender
Sexes Eligible for Study: Male
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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
Responsible Party Swiss Group for Clinical Cancer Research
Study Sponsor Swiss Group for Clinical Cancer Research
Collaborators
  • ProteoMediX AG
  • Cantonal Hospital of St. Gallen
Investigators
Study Chair: Daniel Engeler, MD Cantonal Hospital of St. Gallen
PRS Account Swiss Group for Clinical Cancer Research
Verification Date June 2021

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