Impact of atorvastatin on prostate cancer progression after initiation of androgen deprivation therapy

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Pirkanmaan hyvinvointialue

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male

Therapeutic area

Diseases [C] - Neoplasms [C04], Diseases [C] - Male Urogenital Diseases [C12]

Trial duration

5 Aug 2019 → ongoing

Decision date (initial)

2024-10-21

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-517854-91-00

EudraCT number

2016-004774-17

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Therapy

Whether intervention with atorvastatin delays prostate cancer progression i.e. development of castration
resistance compared to placebo during androgen deprivation therapy (ADT) for advanced prostate cancer.

Conditions and MedDRA coding

Metastatic or high-risk recurrent prostate cancer managed with androgen deprivation therapy

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Histopathologically confirmed metastatic adenocarcinoma of the prostate (radiologically confirmed bone or soft tissue metastasis or enlarged lymph nodes at minimum 15 mm in diameter beyond the pelvic lymph nodes) for which androgen deprivation or antiandrogen therapy (GnRH agonist/antagonist, bicalutamide/flutamide, surgical castration or enzalutamide/abiraterone monotherapy) is initiated no longer than 3 months before either as the primary treatment
2. High-risk M0 stage prostate cancer recurring after curative-intent primary therapy (surgery or radiotherapy) for which androgen deprivation or antiandrogen therapy (GnRH agonist/antagonist, bicalutamide/flutamide, surgical castration or enzalutamide/abiraterone monotherapy) is initiated no longer than 3 months before recruitment. • High risk M0 prostate cancer defined when one of the following criteria fulfilled: o Primarily Gleason 8-10 cancer OR o PSA doubling time ≤ 6 months OR o PSA ≥ 20 ng/ml OR o new lymph node metastases in imaging o previous prostatectomy and radiation therapy allowed o ADT/antiandrogen therapy for neoadjuvant hormone therapy is not included
3. Willingness to participate and signing of informed consent

Exclusion criteria 6

1. Statin use at the time of recruitment or within 6 months of it
2. Previous adverse effects during statin therapy
3. Familial hypercholesterolemia or very high total cholesterol (9.3 mmol/l or above)
4. Clinically significant renal insufficiency (serum creatinine above 170 µmol/l) or liver insufficiency (serum alanine aminotransferase more than 2x above the upper limit of normal range)
5. 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)
6. Hypersensitivity to the active substance (atorvastatin) or to any of the excipients in the atorvastatin product (microcrystalline cellulose, sodium carbonate, maltose, croscarmellose sodium, magnesium stearate, hypromellose (E464), hydroxypropylcellulose, triethyl citrate (E1505), polysorbate 80 or titanium dioxide (E171)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Time to disease progression after starting ADT/antiandrogen therapy

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Pirkanmaan hyvinvointialue

Sponsor organisation

Pirkanmaan hyvinvointialue

Address

Elamanaukio 2

City

Tampere

Postcode

33520

Country

Finland

Scientific contact point

Organisation

Pirkanmaan hyvinvointialue

Contact name

Teemu Murtola

Public contact point

Organisation

Pirkanmaan hyvinvointialue

Contact name

Teemu Murtola

Third parties 1

Locations

4 EU/EEA countries · 12 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 50 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications