Prostatic NeoplasmsNCT04024475
Prostate Cancer Biobank
An observational study of Prostatic Neoplasms, run by Swiss Cancer Institute at 12 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- Prostatic Neoplasms
- What is being tested?
- Observation
- How many people
- 1,323 participants
- Where
- 12 sitesSwitzerland
- Study dates
- 4 Nov 2014to Nov 2029
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: See description under "Groups/Cohorts"
Who may be able to join
- 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
Show all 24Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Switzerland12 sites
Kantonsspital Baden
Baden, 5404
Universitaetsspital-Basel
Basel, 4031
Inselspital Bern
Bern, CH-3010
Spitalzentrum Biel
Biel, CH-2501
Kantonsspital Graubuenden
Chur, 7000
Hopital Fribourgeois HFR
Fribourg, 1708
Hôpitaux Universitaires Genève HUG
Geneva, 1211
Luzerner Kantonsspital
Lucerne, 6000
Clinica Luganese
Lugano, 6900
Kantonsspital Olten
Olten, 4600
Kantonsspital St. Gallen
Sankt Gallen, 9007
Spital STS AG
Thun, 3600
About this study
Official title: 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.
Read the 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:
- 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.
- Conditions
- Prostatic Neoplasms
- Being tested
- Observation
- Keywords
- Radical prostatectomy, Metastatic castration resistant prostate cancer, Oligometastatic prostate cancer, Radiotherapy, Prostate cancer screening, Prostate-specific antigen (PSA), Prostate cancer (PCa), Opportunistic screening
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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 Receives: Other: Observation | |
| C: Biochemical relapse | Patients with PSA progression after RP with or without systemic therapy Receives: 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. Receives: Other: Observation | |
| E: Metastatic castration resistant prostate cancer (mCRPC) | Metastatic castration resistant prostate cancer (mCRPC). Oligometastatic PCa. Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Group A: Time to prostate cancer (PCa) histological diagnosis
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.
Measured: At the occurrence of a positive biopsy result or latest 10 years after registration
Group B0: Progression free survival (PFS)
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
Measured: At 1 year after assigned into Group B0
Group B1: Biochemical relapse free survival
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).
Measured: At 5 years after assigned into Group B1
Group B2-B3: Interval to biochemical failure (IBF)
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.
Measured: At 18 months after assigned into Group B2-B3
Group C: Progression free survival (PFS)
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.
Measured: At progression or latest 10 years after assigned into Group C
Group D: Biochmical prostate specific antigen progression
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.
Measured: At 6 months after induction of androgen deprivation therapy
Group E: Overall survival (OS)
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.
Measured: At death or latest 10 years after assigned into Group E
Secondary outcomes (6)
Group A, B0-B3, C, D: Overall survival (OS)
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.
Measured: At death from any cause or latest 10 years after assigned into the corresponding Group
Group A, B1-B3, C: Time to PCa-specific death
Time to PCa-specific death is calculated from the time when patients were assigned into the group until death due to cancer occurs.
Measured: At prostate cancer related death or latest 10 years after assigned into the corresponding Group
Group B0: Progression free survival (PFS)
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
Measured: At the occurrence of the event or latest 10 year after assigned into Group B0
Group B0: Event free survival (EFS)
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)
Measured: At the occurrence of the event or latest 10 year after assigned into Group B0
Group D: Progression free survival (PFS)
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
Measured: At the occurrence of the event or latest 10 year after assigned into Group D
Group E: Progression free survival (PFS)
PFS will be calculated from the time when patients were assigned into group E until disease progression or death.
Measured: At the occurrence of the event or latest 10 year after assigned into Group E
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2019
- Study start4 Nov 2014
- Primary completionDec 2022 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,323 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Swiss Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- ProteoMediX AG, Cantonal Hospital of St. Gallen
- Responsible party
- Sponsor
- Investigators
- Daniel Engeler, MD, Study chair, Cantonal Hospital of St. Gallen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04024475
- Sponsor's protocol ID
- SAKK 63/12
- Status last verified
- Jun 2022
- First submitted
- 11 Jul 2019
- Last updated
- 8 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data may be shared on reasonable request, after internal and ethical approval
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study With Collection of Clinical Data, Serum and Plasma of Patients With Prostate Disease
- ClinicalTrials.gov ID
- NCT04024475
- Acronym / sponsor ID
- SAKK 63/12
- Conditions
- Prostatic Neoplasms
- Keywords
- Radical prostatectomy, Metastatic castration resistant prostate cancer, Oligometastatic prostate cancer, Radiotherapy, Prostate cancer screening, Prostate-specific antigen (PSA), Prostate cancer (PCa), Opportunistic screening
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,323 participants (actual)
- Lead sponsor
- Swiss Cancer InstituteUniversity, hospital or other
- Collaborators
- ProteoMediX AG, Cantonal Hospital of St. Gallen
- Study start
- 4 Nov 2014 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Nov 2029 (estimated)
- First posted
- 18 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| A: Opportunistic screening & benign prostate syndrome (BPS) | – | Other: ObservationAsymptomatic 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) |
| B: Localized/locally advanced PCa with curative intent | – | Other: ObservationB0: 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 |
| C: Biochemical relapse | – | Other: ObservationPatients with PSA progression after RP with or without systemic therapy |
| D: Metastatic PCa but hormone sensitive | – | Other: ObservationMetastatic PCa without curative treatment but hormone sensitive disease, treated with ADT (medical or surgical), with or without additive treatments. Oligometastatic PCa. |
| E: Metastatic castration resistant prostate cancer (mCRPC) | – | Other: ObservationMetastatic castration resistant prostate cancer (mCRPC). Oligometastatic PCa. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- See description under "Groups/Cohorts"
Key inclusion criteria (24 listed)
- 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
- Patient under active surveillance for localized PCa
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observation | Other | A: Opportunistic screening & benign prostate syndrome (BPS), B: Localized/locally advanced PCa with curative intent, C: Biochemical relapse, D: Metastatic PCa but hormone sensitive, E: Metastatic castration resistant prostate cancer (mCRPC) |
Primary outcome
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.
6 secondary outcomes
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
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
Group B0: Progression free survival (PFS)
Time frame: At the occurrence of the event or latest 10 year after assigned into Group B0
Group B0: Event free survival (EFS)
Time frame: At the occurrence of the event or latest 10 year after assigned into Group B0
Group D: Progression free survival (PFS)
Time frame: At the occurrence of the event or latest 10 year after assigned into Group D
Group E: Progression free survival (PFS)
Time frame: At the occurrence of the event or latest 10 year after assigned into Group E
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2022.
- Individual participant dataSharing planned: Yes. Data may be shared on reasonable request, after internal and ethical approval
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Engeler, MD study chair
Cantonal Hospital of St. Gallen
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostatic Neoplasms, run by Swiss Cancer Institute at 12 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2022.