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APACA-Apheresis/acoustophoresis and Molecular Characterization of Prostate Cancer

NCT ID: NCT06709326

Last Updated: 2024-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-29

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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In this prospective clinical study, led by Umeå University, all research subjects will undergo apheresis and subjects with cancer will also undergo multiple radiological examinations to both identify apheresis and subsequent experimental protocols for isolation of tumor cells, immune cells and other components from the blood. The goal is to increase the sensitivity of identifying circulating tumor cells in early-stage metastatic prostate cancer for molecular characterization without biopsies of metastases. By doing this on multiple occasions in primary metastatic prostate cancer, investigators will identify early resistance mechanisms to given treatment and also investigate immune changes to standard treatment of metastatic prostate cancer (castration). Through qualitative approach, investigators will identify healthy and risk factors for managing the diagnosis of metastatic prostate cancer and the experience of undergoing apheresis to identify circulating tumor cells (CTC) in the blood, with the aim of identifying possible risks for mental health with this research.

Conditions

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Prostate Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Three groups of research subjects

1. Primary metastatic prostate cancer
2. PSA relapse
3. Healthy research subjects
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Primary metastatic prostate cancer

Men who have not previously received treatment for prostate cancer.

Group Type EXPERIMENTAL

Apheresis

Intervention Type 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.

Androgen deprivation therapy

Intervention Type 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.

PSA relapse

Men with PSA recurrance after surgery.

Group Type EXPERIMENTAL

Apheresis

Intervention Type 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.

Anti androgen therapy

Intervention Type 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.

Healthy research subjects

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

Group Type OTHER

Apheresis

Intervention Type 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type OTHER

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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)


One of the following criteria:

* PSA \>100ng/ml
* Skeletal metastases with high risk of prostate cancer (regardless of PSA-value)


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)


All of the following two criteria must be fulfilled:

* Previously healthy (no ongoing medication)
* No history of cancer

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

81 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Umeå University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andreas Josefsson, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of surgical and perioperative sciences, Urology, Umeå University

Locations

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Department of surgical and perioperative sciences, Umeå university

Umeå, Norrlands University Hospital, Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Andreas Josefsson, MD, PhD

Role: CONTACT

[email protected]
+46 70 3805395

Facility Contacts

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Andreas Josefsson, MD, PhD

Role: primary

[email protected]
+46 70 3805395

Other Identifiers

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APACA

Identifier Type: -

Identifier Source: org_study_id