Prostate Cancer Biobank

NCT04024475 | Active Not Recruiting DMC

• 1 other identifier: SAKK 63/12
• Study Type: observational
• Target: 1,323
• Locations: 1 country
• Sites: 12

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.

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

Outcome Measures

Primary Outcomes (7)

• 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.

  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

  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).

  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.

  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.

  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.

  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.

  At death or latest 10 years after assigned into Group E

Secondary Outcomes (6)

• Group A, B0-B3, C, D: Overall survival (OS)

  At death from any cause or latest 10 years after assigned into the corresponding Group

• Group A, B1-B3, C: Time to PCa-specific death

  At prostate cancer related death or latest 10 years after assigned into the corresponding Group

• Group B0: Progression free survival (PFS)

  At the occurrence of the event or latest 10 year after assigned into Group B0

• Group B0: Event free survival (EFS)

  At the occurrence of the event or latest 10 year after assigned into Group B0

• Group D: Progression free survival (PFS)

  At the occurrence of the event or latest 10 year after assigned into Group D

Study Arms (5)

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

Interventions

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)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

See description under "Groups/Cohorts"

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Swiss Cancer Institute: lead
• ProteoMediX AG: collaborator
• Cantonal Hospital of St. Gallen: collaborator

Study Sites (12)

Kantonsspital Baden

Baden, 5404, Switzerland

Location

Universitaetsspital-Basel

Basel, 4031, Switzerland

Location

Inselspital Bern

Bern, CH-3010, Switzerland

Location

Spitalzentrum Biel

Biel, CH-2501, Switzerland

Location

Kantonsspital Graubuenden

Chur, 7000, Switzerland

Location

Hopital Fribourgeois HFR

Fribourg, 1708, Switzerland

Location

Hôpitaux Universitaires Genève HUG

Geneva, 1211, Switzerland

Location

Luzerner Kantonsspital

Lucerne, 6000, Switzerland

Location

Clinica Luganese

Lugano, 6900, Switzerland

Location

Kantonsspital Olten

Olten, 4600, Switzerland

Location

Kantonsspital St. Gallen

Sankt Gallen, 9007, Switzerland

Location

Spital STS AG

Thun, 3600, Switzerland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, plasma, and buffy coat samples; Prostate biopsies

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Observation

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Daniel Engeler, MD

  Cantonal Hospital of St. Gallen

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2019
• First Posted: July 18, 2019
• Study Start: November 4, 2014
• Primary Completion: December 1, 2022
• Study Completion (Estimated): November 1, 2029
• Last Updated: June 8, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share

Locations

CH (12)