Clinical trial NCT07013890: Efficacy of Phycocyanin and Palmitoylethanolamide for the Treatment of Chronic Prostatitis Symptoms
Official title: Effectiveness and Safety of an Association of Phycocyanin and Palmitoylethanolamide in Patients With Chronic Prostatitis/Chronic Pelvic Pain Syndrome: A Prospective Observational Multicentric Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Prostatitis (CP)
Chronic Prostatitis With Chronic Pelvic Pain Syndrome
Chronic Prostatitis/ Pelvic Pain Syndrome
Keywords: Chronic prostatitis
chronic pelvic pain syndrome
LUTS
pain
phycocyanin
palmitoylethanolamide
FICOXPEA®
phytotherapy
Lead sponsor: Clinica Urologica Molinette - Città della Saliute e della Scienza
Sponsor class: OTHER
Collaborators: name: A.O.U. Città della Salute e della Scienza - Molinette Hospital
First posted: 2025-06-10
Enrollment: 48
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: prospective, observational, multicentric, single-arm study
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Statistically significant decrease of CPSI total score compared to baseline
timeFrame: 1 month and 3 months
Secondary outcomes:
measure: Statistically significant decrease of CPSI pain domain score compared to baseline
timeFrame: 1 month and 3 months
measure: Statistically significant decrease of CPSI QoL domain score compared to baseline
timeFrame: 1 month and 3 months
measure: Statistically significant decrease of total PSA
timeFrame: 1 month and 3 months
measure: n° of any adverse events
timeFrame: 1 month and 3 months
Other outcomes:
Locations:
city: Catania
country: Italy
facility: Dipartimento di Chirurgia Università di Catania
city: Torino
country: Italy
facility: Molinette Hospital
Study officials:
References:
citation: Wagenlehner FM, Schneider H, Ludwig M, Schnitker J, Brahler E, Weidner W. A pollen extract (Cernilton) in patients with inflammatory chronic prostatitis-chronic pelvic pain syndrome: a multicentre, randomised, prospective, double-blind, placebo-controlled phase 3 study. Eur Urol. 2009 Sep;56(3):544-51. doi: 10.1016/j.eururo.2009.05.046. Epub 2009 Jun 3.
citation: Litwin MS, McNaughton-Collins M, Fowler FJ Jr, Nickel JC, Calhoun EA, Pontari MA, Alexander RB, Farrar JT, O'Leary MP. The National Institutes of Health chronic prostatitis symptom index: development and validation of a new outcome measure. Chronic Prostatitis Collaborative Research Network. J Urol. 1999 Aug;162(2):369-75. doi: 10.1016/s0022-5347(05)68562-x.
citation: Sibona M, Destefanis P, Agnello M, Lillaz B, Giuliano M, Cai T, Gontero P. The association of Boswellia resin extract and propolis derived polyphenols can improve quality of life in patients affected by prostatitis-like symptoms. Arch Ital Urol Androl. 2020 Jan 14;91(4):251-255. doi: 10.4081/aiua.2019.4.251.
citation: Cai T, Luciani LG, Caola I, Mondaini N, Malossini G, Lanzafame P, Mazzoli S, Bartoletti R. Effects of pollen extract in association with vitamins (DEPROX 500(R)) for pain relief in patients affected by chronic prostatitis/chronic pelvic pain syndrome: results from a pilot study. Urologia. 2013 Apr 24;80 Suppl 22:5-10. doi: 10.5301/RU.2013.10597. Epub 2013 Jan 16.