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Chronic Prostatitis (CP)Phase 4NCT07013890

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

A Phase 4 study testing FICOXPEA® is an oral combination of Phycocyanin, Palmitoylethanolamide and selenium in people with Chronic Prostatitis (CP) and Chronic Prostatitis With Chronic Pelvic Pain Syndrome, run by Clinica Urologica Molinette - Città della Saliute e della Scienza at 2 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
FICOXPEA® is an oral combination of Phycocyanin, Palmitoylethanolamide and selenium
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
2 sitesItaly
Study dates
2 Nov 2022to 30 Sep 2023
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Italy2 sites

  • Dipartimento di Chirurgia Università di Catania

    Catania

  • Molinette Hospital

    Torino, Torino, 10126

Other trials in Italy

About this study

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

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.

Read more

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.
Being tested
FICOXPEA® is an oral combination of Phycocyanin, Palmitoylethanolamide and selenium
Keywords
Chronic prostatitis, chronic pelvic pain syndrome, LUTS, pain, phycocyanin, palmitoylethanolamide, FICOXPEA®, phytotherapy
Medical subject headings
Prostatitis, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FICOXPEA® is an oral combination of Phycocyanin, Palmitoylethanolamide and seleniumDrug

    FICOXPEA® is a phytoterapic compound made of:

    • phycocyanin (spirulina platensis extract) 250 mg
    • palmitoylethanolamide 200 mg
    • L-selenometionine 11 mg
Study groups in NCT07013890
Study groupRoleWhat they receive
FICOXPEA®ExperimentalFICOXPEA® 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
Receives: Drug: FICOXPEA® is an oral combination of Phycocyanin, Palmitoylethanolamide and selenium

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Improvement of CP symptoms

    Measured: 1 month and 3 months

Secondary outcomes (4)

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

    improvement of CP pain symptoms

    Measured: 1 month and 3 months

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

    Improvement of CP QoL

    Measured: 1 month and 3 months

  3. Statistically significant change of total PSA

    Decrease of chronic altered PSA values

    Measured: 1 month and 3 months

  4. n° of any adverse events

    number and type, so safety analysis

    Measured: 1 month and 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2025
  2. Study start2 Nov 2022
  3. Primary completion15 Aug 2023
  4. Study completion30 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
prospective, observational, multicentric, single-arm study
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07013890
Sponsor's protocol ID
CET n. 530/2021
Status last verified
Jan 2025
First submitted
2 Jun 2025
Last updated
24 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 19524353

  • 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.

    PubMed 10411041

  • 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.

    PubMed 31937091

  • 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.

    PubMed 23334883

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing FICOXPEA® is an oral combination of Phycocyanin, Palmitoylethanolamide and selenium in people with Chronic Prostatitis (CP) and Chronic Prostatitis With Chronic Pelvic Pain Syndrome, run by Clinica Urologica Molinette - Città della Saliute e della Scienza at 2 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Statistically significant change of CPSI total score compared to baseline (time frame: 1 month and 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07013890, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2025.

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