Efficacy of Phycocyanin and Palmitoylethanolamide for the Treatment of Chronic Prostatitis Symptoms (NCT07013890) | Clinical Trial Compass
CompletedPhase 4
Efficacy of Phycocyanin and Palmitoylethanolamide for the Treatment of Chronic Prostatitis Symptoms
Italy48 participantsStarted 2022-11-02
Plain-language summary
Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is a bothering condition characterized by pain localized to the pelvic, perineal and/or genital area and lower urinary tract symptoms (LUTS). Phytotherapy, which involves the combination of two or more active compounds, can be used to treat this challenging condition.
The aim of this study was to investigate the role of an association of phycocyanin (PC) and palmitoylethanolamide (PEA) and selenium (FICOXPEA®) in male patients affected by CP/CPPS.
The main questions the present study aims to answer are:
* Does FICOXPEA® enhance quality of life of CPP/CPPS patients?
* Does it help reducing pain symptoms of CPP/CPPS patients?
Researchers will investigate whether FICOXPEA® works to treat CPP/CPPS symptoms, so its efficacy, but also its tolerability and adherence to therapy.
Participants will:
* Take FICOXPEA® once a day for 30 days;
* Visit the clinic for follow-up visits at 1 and 3 months;
* Answer validated questionnaires and declare potential adverse events at follow-up visits.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* adult male patients (aged \>18 years)
* clinical affection by CP/CPPS with symptoms that persisted for ≥ 3 months;
* PSA values of 4 to 10 ng/ml (at least 2 determinations)
* patients must have completed diagnostic work-up, such as multiparametric prostate MRI (evidence level 1a according to EAU guidelines) with or without subsequent prostate biopsy (according to the diagnostic flow-chart depicted by EAU international guidelines).
Exclusion Criteria:
* patients with previous diagnosis of prostate cancer
* patients who underwent previous low urinary tract surgery
* patients who underwent previous intravescical chemotherapy
* patients with acute bacterial prostatitis
* diagnostic work-up for prostate cancer not completed
* patients having antibiotic therapy or specific chronic prostatis treatment (phytotherapy included) or benign prostatic iperplasia treatment (e.g. alpha litics) at the time of the recruitment or finished less than a month before
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Statistically significant change of CPSI total score compared to baseline
Timeframe: 1 month and 3 months
Trial details
NCT IDNCT07013890
SponsorClinica Urologica Molinette - Città della Saliute e della Scienza