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Clinical Trials in Sweden / NCT06709326
Recruiting Not applicable

APACA-Apheresis/acoustophoresis and Molecular Characterization of Prostate Cancer

NCT06709326 · tracked via the Priya Life Science Sweden tracker
Sponsor
Umeå University
Phase
Not applicable
Started
2020-09-29
Last updated
2024-11-29

Condition(s) studied

Prostate Cancer

Investigational drug(s) / intervention(s)

ApheresisAndrogen deprivation therapyAnti androgen therapy

Apheresis: 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.

Androgen 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.

Anti 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.

Study 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
MALE
Min age
18 Years
Max age
81 Years
Healthy volunteers
Accepted
Inclusion Criteria: -The patient (arm 1 and arm 2) must have a health status that minimises the already low risks of the apheresis treatment, have the logistical possibilities to come to the visits according to the study and be planned for treatment according to standard treatment in Sweden today. For arm 1, 2 and 3: * Venous blood vessels enabling apheresis * ECOG-performance status 0-2 * Concentration of av potassium, calcium and magnesium in blood within normal range * Testosterone\>1,7 nmol/L * Hb\>90 g/L * TPK \>50x10exp9 /L * LPK \>1x10exp9 /L * Bilirubin \<1,4 x upper limit for normal (unless the subject suffers from Gilberts disease) * ALAT or ASAT \<2,4 x above limit for normal * Creatinine \<2 mg/dL (\<177µmol/L) Additional inclusion criteria for Arm 1 - Metastatic prostate cancer One of the following criteria: * PSA \>100ng/ml * Skeletal metastases with high risk of prostate cancer (regardless of PSA-value) Additional inclusion criteria for Arm 2 - PSA relapse after operation All of the three following criteria must be fulfilled: * Prostatectomy * PSA \>0.2ng/ml * PSA doubling time \<18 months (according to www.mskcc.org/nomograms/prostate/psa\_doubling\_time) Additional inclusion criteria for Arm 3 - Healthy research subjects (control group) All of the following two criteria must be fulfilled: * Previously healthy (no ongoing medication) * No history of cancer Exclusion Criteria for arm 1, 2 and 3: * Overall, research subjects must not have any other cancer disease or risk factors for undergoing apheresis treatment * Weight \<50 kg * Medical castration last 6 months (or previous surgical castration) * Antiandrogen treatment in the last 6 months * Previous myocardial infarction, stroke, chronic heart failure, atrial fibrillation or multiple deep vein thromboses * Heart rate \<45 * Systolic blood pressure below 100 * Ongoing diagnosed chronic inflammation

Primary outcome measure(s)

  • Identify circulating tumor cells (CTC) for molecular characterization — At inclusion in the study and after 4 weeks of treatment.
    Identification of circulating tumor cells will be accomplished by RNA-based phenotyping using lineage specific transcripts.
  • Differentiated gene expression in CTCs before and after treatment start — At inclusion in the study and after 4 weeks of treatment.
    To find resistance mechanisms by deep molecular characterization of CTC before and after treatment start to identify up and down regulations of genes in paired samples.
  • Phenotypical changes of immune cells due to anti-androgen treatment — At inclusion in the study, after 4 weeks of treatment, after 3, 6 and 12 months of treatment.
    Broad molecular characterization of immune cells before initiation of treatment and at different time points after anti-androgen treatment

Trial sites (1)

FacilityCityRegionStatus
Department of surgical and perioperative sciences, Umeå university Umeå Norrlands University Hospital Recruiting

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Other trials for the same condition

Personalized Radiotherapy for Biochemical Recurrence of Prostate Cancer After Prostatectomy. Recruiting
Artificial Intelligence Supporting CAncer Patients Across Europe - the ASCAPE Project Active, not recruiting
SPCG17: Prostate Cancer Active Surveillance Trigger Trial Active, not recruiting
Prostate Cancer IRE Study (PRIS) Active, not recruiting
International Registry for Men With Advanced Prostate Cancer (IRONMAN) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06709326 on ClinicalTrials.gov ↗ ← All trials in Sweden