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Completed

NCT Number: NCT07013890

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

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.

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Key information

Conditions

Chronic Prostatitis (CP) Chronic Prostatitis With Chronic Pelvic Pain Syndrome Chronic Prostatitis/ Pelvic Pain Syndrome Genital Diseases Genital Diseases, Male Male Urogenital Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatitis Signs and Symptoms Urogenital Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Molinette Hospital, Torino, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Statistically significant change of CPSI total score compared to baseline

    Time frame: 1 month and 3 months

    Improvement of CP symptoms

Secondary outcomes

  1. Statistically significant change of CPSI pain domain score compared to baseline

    Time frame: 1 month and 3 months

    improvement of CP pain symptoms

  2. Statistically significant change of CPSI QoL domain score compared to baseline

    Time frame: 1 month and 3 months

    Improvement of CP QoL

  3. Statistically significant change of total PSA

    Time frame: 1 month and 3 months

    Decrease of chronic altered PSA values

  4. n° of any adverse events

    Time frame: 1 month and 3 months

    number and type, so safety analysis

Sponsors and collaborators

Lead sponsor

Clinica Urologica Molinette - Città della Saliute e della Scienza

Other

Collaborators

  • A.O.U. Città della Salute e della Scienza - Molinette Hospital

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 10, 2025
Registry last updated
Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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