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New treatment option for Prostate Cancer
Official title APACA-Apheresis/acoustophoresis and Molecular Characterization of Prostate Cancer
ClinicalTrials.gov ID: NCT06709326
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 81, men only. Healthy volunteers may be eligible.
You may be able to join 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...
- 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
You likely can't join if
- for arm 1, 2 and 3:
- Overall, research people 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
See the full eligibility 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...
- 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 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 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 for Arm 3 - Healthy research people (control group) All of the following two criteria must be fulfilled:
- Previously healthy (no ongoing medication)
- No history of cancer
- for arm 1, 2 and 3:
- Overall, research people 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
The study team makes the final eligibility decision.
Where it's taking place
- Umeå, Norrlands University Hospital, Sweden
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years to 81 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Umeå, Norrlands University Hospital, Sweden. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.