Health Trials

Trial of Acetylsalicylic Acid and Atorvastatin in Patients With Castrate-resistant Prostate Cancer

ConditionProstate Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age18+
SponsorGustave Roussy, Cancer Campus, Grand Paris

About this trial

This is a 2x2 factorial randomized, multicenter, international, open phase III trial.

The primary objective is to evaluate the benefit of acetylsalicylic acid and atorvastatin on overall survival (OS) (main endpoint) for patients with castrate-resistant prostate cancer starting first line treatment for CRPC

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically confirmed adenocarcinoma of the prostate and no curative local therapy considered possible

Age ≥ 18 years, life expectancy of at least 6 months

CRPC defined as tumor progression (PSA increase on at least 2 separate values separated by at least 1 week or progression on imaging) while on Androgen Deprivation Therapy (orchiectomy, LHRH agonist or -antagonist) with documented serum testosterone levels ≤ 1.7 nmol/L (≤ 0.50 ng/mL). Ongoing concurrent use of LHRH agonist or antagonist is required if the patient has not been surgically castrated

Presence (M1) or absence (M0) of metastases on imaging

Disqualifiers

Previous localised malignancy within 2 years with the exception of localized non-melanoma skin cancer and Ta or Tis bladder cancer (patients with asymptomatic Chronic Lymphocytic Leukemia can be included)

Previous metastatic malignancy within 5 years

Patient currently taking daily acetylsalicylic acid or a daily statin within the last 6 months

Patients with active liver disease (hepatitis B or C, cirrhosis) or unexplained persistent elevations of serum transaminases exceeding 3 times the upper limit of normal or cholestasis

Trial design

Design model

Factorial

Treatments tested in this trial

  • Acetylsalicylic acid

    Drug

    100mg

  • Atorvastatin

    Drug

    80 mg

Treatment groups

1,210 Participants
are divided into 4 treatment groups
Group A: Arm ANo intervention 0 interventions
Group B: Arm BExperimental treatment 1 intervention
Group C: Arm CExperimental treatment 1 intervention
Group D: Arm DExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Overall Survival (OS)

Time frame
OS will be calculated from the date of randomization to the date of death up to 15 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Gustave Roussy, Cancer Campus, Grand Paris

Lead sponsor

National Cancer Institute, France

Collaborator

Source ClinicalTrials.gov
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