Efficacy of Phycocyanin and Palmitoylethanolamide for the Treatment of Chronic Prostatitis Symptoms

NCT07013890 | Completed Phase 4

• 1 other identifier: CET n. 530/2021
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• Statistically significant change of CPSI total score compared to baseline

  Improvement of CP symptoms

  1 month and 3 months

Secondary Outcomes (4)

• Statistically significant change of CPSI pain domain score compared to baseline

  1 month and 3 months

• Statistically significant change of CPSI QoL domain score compared to baseline

  1 month and 3 months

• Statistically significant change of total PSA

  1 month and 3 months

• n° of any adverse events

  1 month and 3 months

Study Arms (1)

FICOXPEA®

EXPERIMENTAL

FICOXPEA® is a phytoterapic compound made of: * phycocyanin (spirulina platensis extract) 250 mg * palmitoylethanolamide 200 mg * L-selenometionine 11 mg 1. capsule containing all these compounds is administered every day for 30 days

Drug: FICOXPEA® is an oral combination of Phycocyanin, Palmitoylethanolamide and selenium

Interventions

FICOXPEA® is an oral combination of Phycocyanin, Palmitoylethanolamide and selenium DRUG

FICOXPEA® is a phytoterapic compound made of: * phycocyanin (spirulina platensis extract) 250 mg * palmitoylethanolamide 200 mg * L-selenometionine 11 mg

FICOXPEA®

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Male patients (with a prostate)
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinica Urologica Molinette - Città della Saliute e della Scienza: lead
• A.O.U. Città della Salute e della Scienza - Molinette Hospital: collaborator

Study Sites (2)

Molinette Hospital

Torino, Torino, 10126, Italy

Location

Dipartimento di Chirurgia Università di Catania

Catania, Italy

Location

Related Publications (4)

• 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.

  PMID: 19524353 BACKGROUND

• 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.

  PMID: 10411041 BACKGROUND

• 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.

  PMID: 31937091 BACKGROUND

• 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.

  PMID: 23334883 BACKGROUND

MeSH Terms

Conditions

Prostatitis; Pain

Interventions

palmidrol; Selenium

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Minerals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Urologist, MD

Model Details: prospective, observational, multicentric, single-arm study

Study Record Dates

• First Submitted: June 2, 2025
• First Posted: June 10, 2025
• Study Start: November 2, 2022
• Primary Completion: August 15, 2023
• Study Completion: September 30, 2023
• Last Updated: July 24, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)