RecruitingNot ApplicableNCT06709326

APACA-Apheresis/acoustophoresis and Molecular Characterization of Prostate Cancer


Sponsor

Umeå University

Enrollment

130 participants

Start Date

Sep 29, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical study is to to improve diagnosis, follow-up and treatment for patients with disseminated prostate cancer. The aim is to isolate tumour cells before image diagnostic methods find the metastases. In addition, investigators will use this method to characterise the tumour cells at the "single-cell" level to understand both the metastasis process, early resistance mechanisms and thus find new treatment targets to optimise individualised treatment. Research subjects who either have disseminated disease at diagnosis or have recurrence after surgery (with minimal dissemination) will be included. A control population of young men without cancer will also be recruited to distinguish tumor-specific changes from normal signals using these new methods.


Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 81 Years

Plain Language Summary

Simplified for easier understanding

This study is collecting blood samples from men with prostate cancer using a procedure called apheresis (filtering blood through a machine to collect circulating tumor cells) to better characterize prostate cancer at the molecular level and understand how it evolves during treatment. **You may be eligible if...** - You have prostate cancer and are being treated according to standard Swedish guidelines - You have suitable veins for the apheresis procedure - Your blood counts and organ function meet minimum requirements (hemoglobin, platelets, liver enzymes, kidney function within acceptable ranges) - Your ECOG performance status is 0-2 **You may NOT be eligible if...** - Your blood counts or organ function do not meet the minimum thresholds - You have conditions that would make the apheresis procedure unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTApheresis

Isolate tumor cells, immune cells, exosomes and cell free DNA from the blood by a clinically used method of whole blood volume filtration, apheresis, and subsequent separation of blood components using novel techniques, such as acoustophoresis and other experimental protocols.

OTHERAndrogen deprivation therapy

Apheresis will be performed before initiation of systemic therapy (androgen deprivation therapy) and 4 weeks after. Androgen deprivation therapy is treatment as per clinical routine and not part of the protocol.

DIAGNOSTIC_TESTAnti androgen therapy

Apheresis will be performed before initiation of systemic therapy (anti androgen therapy). Anti androgen therapy is treatment as per clinical routine and not part of the protocol.


Locations(1)

Department of surgical and perioperative sciences, Umeå university

Umeå, Norrlands University Hospital, Sweden

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NCT06709326


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