Prostate Cancer Biobank (NCT04024475) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Prostate Cancer Biobank
Switzerland1,323 participantsStarted 2014-11-04
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 docet…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Group A: Time to prostate cancer (PCa) histological diagnosis
Timeframe: At the occurrence of a positive biopsy result or latest 10 years after registration
2
Group B0: Progression free survival (PFS)
Timeframe: At 1 year after assigned into Group B0
3
Group B1: Biochemical relapse free survival
Timeframe: At 5 years after assigned into Group B1
4
Group B2-B3: Interval to biochemical failure (IBF)
Timeframe: At 18 months after assigned into Group B2-B3
5
Group C: Progression free survival (PFS)
Timeframe: At progression or latest 10 years after assigned into Group C
6
Group D: Biochmical prostate specific antigen progression
Timeframe: At 6 months after induction of androgen deprivation therapy
7
Group E: Overall survival (OS)
Timeframe: At death or latest 10 years after assigned into Group E