Impact of Atorvastatin on Prostate Cancer Progression During ADT

Last updated: October 19, 2022
Sponsor: Tampere University Hospital
Overall Status: Active - Recruiting

Phase

3

Condition

Metastatic Cancer

Prostate Cancer

Urologic Cancer

Treatment

N/A

Clinical Study ID

NCT04026230
2016-004774-17
  • Ages > 18
  • Male

Study Summary

This randomized double-blind placebo-controlled trial tests whether intervention with atorvastatin delays development of castration resistance compared to placebo during androgen deprivation therapy (ADT) for prostate cancer.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histopathologically confirmed metastatic (radiologically confirmed bone or soft tissuemetastasis or enlarged lymph nodes at minimum 15 mm in diameter beyond the pelviclymph nodes) or recurrent (requiring treatment after curative-intent surgery orradiotherapy) adenocarcinoma of the prostate for which androgen deprivation orantiandrogen therapy (GnRH agonist/antagonist, bicalutamide/flutamide, surgicalcastration or enzalutamide/abiraterone monotherapy) is initiated as definitivetreatment no longer than 3 months before recruitment
  • previous prostatectomy and radiation therapy allowed
  • ADT/antiandrogen therapy for neoadjuvant hormone therapy is not included
  • Willingness to participate and signing of informed consent

Exclusion

Exclusion Criteria:

  • Statin use at the time of recruitment or within 6 months of it
  • Previous adverse effects during statin therapy
  • Familial hypercholesterolemia or very high total cholesterol (9.3 mmol/l or above)
  • Clinically significant renal insufficiency (serum creatinine above 170 µmol/l) orliver insufficiency (serum alanine aminotransferase more than 2x above the upper limitof normal range)
  • Use of drugs that may interact with statins (St John's Wort, HIV protease inhibitors,ciclosporin, macrolide antibiotics, fucidic acid, phenytoin, carbamazepine,dronedarone or oral antifungal medication).

Study Design

Total Participants: 400
Study Start date:
August 15, 2019
Estimated Completion Date:
December 31, 2025

Study Description

Cholesterol-lowering statin drugs have been reported to lower proliferation activity in prostate cancer, delay occurrence of castration resistance and reduce the risk of prostate cancer death. Therefore, it is important to test statins' efficacy in addition to conventional prostate cancer treatment in a randomized, placebo-controlled trial.

This phase 3 randomized double-blind placebo-controlled trial will explore whether intervention with atorvastatin delays prostate cancer progression i.e. development of castration resistance compared to placebo during androgen deprivation therapy (ADT) for metastatic or recurrent prostate cancer.

Secondary objectives include exploring whether atorvastatin lowers prostate cancer-specific or overall mortality compared to placebo, and to demonstrate whether changes in serum lipid parameters predict disease recurrence and occurrence of adverse genomic changes predicting castration resistance among prostate cancer patients during ADT.

The study recruitment target is 400 participants who start ADT as management of metastatic or recurrent prostate cancer. These men will be randomized 1:1 (200 + 200) to receive blinded study drug, either 80 mg of atorvastatin daily or placebo until disease recurrence i.e. development of castration resistance or for a maximum of five years.

The study will be carried out in collaboration between urological departments of University Hospitals in Finland as a project of the national FinnProstata study group, Herlev University Hospital in Denmark, Vestfold and Telemark hospitals in Norway and the Tartu University Hospital in Estonia.

Follow-up is continued until the primary end-point, development of castration resistance. After this the participants will be given the opportunity to voluntarily carry on with the blinded intervention for maximum time of ten year to observe effects on survival after development of castration resistance. Blinding will be lifted after the follow-up is complete for all study participants.

Castration resistance is defined as prostate-specific antigen (PSA) progression (three consecutive rises of PSA measured at least 1 week apart with two > 50% increases over the nadir and PSA > 2 ng/ml) or radiological disease progression (appearance of two or more lesions in bone scan or soft tissue enlargement as per RECIST criteria) with serum testosterone at castrate level (< 1.73 nmol/l; 50 ng/dl) during ADT.

Connect with a study center

  • Herlev and Gentofte Hospital

    Herlev,
    Denmark

    Site Not Available

  • Tartu University Hospital

    Tartu,
    Estonia

    Active - Recruiting

  • Helsinki University Hospital, Department of Urology

    Helsinki,
    Finland

    Active - Recruiting

  • Central Finland central hospital

    Jyväskylä,
    Finland

    Active - Recruiting

  • Kuopio University Hospital, Department of Urology

    Kuopio,
    Finland

    Site Not Available

  • Seinäjoki Central Hospital, Department of Surgery

    Seinäjoki,
    Finland

    Active - Recruiting

  • Tampere University Hospital

    Tampere,
    Finland

    Active - Recruiting

  • Turku University Hospital

    Turku,
    Finland

    Active - Recruiting

  • The Hospital of Telemark

    Skien,
    Norway

    Active - Recruiting

  • The Hospital of Vestfold

    Tønsberg,
    Norway

    Active - Recruiting

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