Prostate CancerNCT06709326
APACA-Apheresis/acoustophoresis and Molecular Characterization of Prostate Cancer
A study testing Apheresis, Androgen deprivation therapy and Anti androgen therapy in people with Prostate Cancer, run by Umeå University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 81 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Apheresis, Androgen deprivation therapy and Anti androgen therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteSweden
- Study dates
- 29 Sep 2020to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 81 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -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
Show all 25Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Department of surgical and perioperative sciences, Umeå university
Umeå, Norrlands University Hospital, 90185
Andreas Josefsson, MD, PhD, +46 70 3805395, andreas.josefsson@umu.se
About this study
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.
Read the detailed description
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
- Prostate Cancer
- Being tested
- Apheresis, Androgen deprivation therapy, Anti androgen therapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApheresisDiagnostic 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 therapyOther
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 therapyDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Primary metastatic prostate cancer | Experimental | Men who have not previously received treatment for prostate cancer. Receives: Diagnostic Test: Apheresis; Other: Androgen deprivation therapy |
| PSA relapse | Experimental | Men with PSA recurrance after surgery. Receives: Diagnostic Test: Apheresis; Diagnostic Test: Anti androgen therapy |
| Healthy research subjects | Other | Control group to distinguish tumor-specific changes from normal signals. Receives: Diagnostic Test: Apheresis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify circulating tumor cells (CTC) for molecular characterization
Identification of circulating tumor cells will be accomplished by RNA-based phenotyping using lineage specific transcripts.
Measured: 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.
Measured: 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
Measured: At inclusion in the study, after 4 weeks of treatment, after 3, 6 and 12 months of treatment.
Secondary outcomes (1)
Progression free survival
Time to progression defined as PSA relapse or new metastasis or prostate cancer death, which ever comes first.
Measured: Within 24, 48 and 72 months respectively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start29 Sep 2020
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Three groups of research subjects 1. Primary metastatic prostate cancer 2. PSA relapse 3. Healthy research subjects
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andreas Josefsson, MD, PhD, Principal investigator, Department of surgical and perioperative sciences, Urology, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06709326
- Sponsor's protocol ID
- APACA
- Status last verified
- Oct 2024
- First submitted
- 17 Mar 2023
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- APACA-Apheresis/acoustophoresis and Molecular Characterization of Prostate Cancer
- ClinicalTrials.gov ID
- NCT06709326
- Acronym / sponsor ID
- APACA
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- 29 Sep 2020 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 29 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Three groups of research subjects 1. Primary metastatic prostate cancer 2. PSA relapse 3. Healthy research subjects
| Arm | Type | Receives |
|---|---|---|
| Primary metastatic prostate cancer | Experimental | Diagnostic Test: Apheresis, Other: Androgen deprivation therapyMen who have not previously received treatment for prostate cancer. |
| PSA relapse | Experimental | Diagnostic Test: Apheresis, Diagnostic Test: Anti androgen therapyMen with PSA recurrance after surgery. |
| Healthy research subjects | Other | Diagnostic Test: ApheresisControl group to distinguish tumor-specific changes from normal signals. |
Who may qualify
- Ages
- 18 to 81 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- -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.
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ApheresisIsolate 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. | Diagnostic test | Healthy research subjects, PSA relapse, Primary metastatic prostate cancer |
| Androgen deprivation therapyApheresis 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. | Other | Primary metastatic prostate cancer |
| Anti androgen therapyApheresis 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. | Diagnostic test | PSA relapse |
Primary outcome
Identify circulating tumor cells (CTC) for molecular characterization
Time frame: 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
Time frame: 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
Time frame: 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
1 secondary outcome
Progression free survival
Time frame: Within 24, 48 and 72 months respectively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Josefsson, MD, PhD principal investigator
Department of surgical and perioperative sciences, Urology, Umeå University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Apheresis, Androgen deprivation therapy and Anti androgen therapy in people with Prostate Cancer, run by Umeå University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andreas Josefsson, MD, PhD (+46 70 3805395, andreas.josefsson@umu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify circulating tumor cells (CTC) for molecular characterization (time frame: At inclusion in the study and after 4 weeks of treatment.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2024.