APACA-Apheresis/acoustophoresis and Molecular Characterization of Prostate Cancer

NCT06709326 | Recruiting DMC

• 1 other identifier: APACA
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (3)

• Identify circulating tumor cells (CTC) for molecular characterization

  Identification of circulating tumor cells will be accomplished by RNA-based phenotyping using lineage specific transcripts.

  At inclusion in the study and after 4 weeks of treatment.

• Differentiated gene expression in CTCs before and after treatment start

  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.

  At inclusion in the study and after 4 weeks of treatment.

• Phenotypical changes of immune cells due to anti-androgen treatment

  Broad molecular characterization of immune cells before initiation of treatment and at different time points after anti-androgen treatment

  At inclusion in the study, after 4 weeks of treatment, after 3, 6 and 12 months of treatment.

Secondary Outcomes (1)

• Progression free survival

  Within 24, 48 and 72 months respectively

Study Arms (3)

Primary metastatic prostate cancer

EXPERIMENTAL

Men who have not previously received treatment for prostate cancer.

Diagnostic Test: Apheresis; Other: Androgen deprivation therapy

PSA relapse

EXPERIMENTAL

Men with PSA recurrance after surgery.

Diagnostic Test: Apheresis; Diagnostic Test: Anti androgen therapy

Healthy research subjects

OTHER

Control group to distinguish tumor-specific changes from normal signals.

Diagnostic Test: Apheresis

Interventions

Apheresis DIAGNOSTIC_TEST

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.

Healthy research subjects; PSA relapse; Primary metastatic prostate cancer

Androgen deprivation therapy OTHER

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.

Primary metastatic prostate cancer

Anti androgen therapy DIAGNOSTIC_TEST

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.

PSA relapse

Eligibility Criteria

• Age: 18 Years - 81 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• One of the following criteria:
• PSA \>100ng/ml
• Skeletal metastases with high risk of prostate cancer (regardless of PSA-value)

You may not qualify if:

• 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

Sponsors & Collaborators

• Umeå University: lead

Study Sites (1)

Department of surgical and perioperative sciences, Umeå university

Umeå, Norrlands University Hospital, 90185, Sweden

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Androgen Antagonists

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)

Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Andreas Josefsson, MD, PhD

  Department of surgical and perioperative sciences, Urology, Umeå University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andreas Josefsson, MD, PhD

CONTACT

+46 70 3805395; andreas.josefsson@umu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Three groups of research subjects 1. Primary metastatic prostate cancer 2. PSA relapse 3. Healthy research subjects

Study Record Dates

• First Submitted: March 17, 2023
• First Posted: November 29, 2024
• Study Start: September 29, 2020
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: November 29, 2024

Record last verified: 2024-10

Locations

SE (1)