Metastatic Castration-resistent Prostate Cancer Clinical Trial
Official title:
A Randomized Multicenter Phase III Trial Comparing Docetaxel or Hormone Therapy as Second Line Treatment in Patients With Asymptomatic or Oligosymptomatic Metastatic Castration-resistent Prostate Cancer (mCRPC) Progressing After Abiraterone or Enzalutamide.
| Verified date | March 2023 |
| Source | National Cancer Institute, Naples |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This is a randomized phase 3 trial aiming to compare the efficacy of docetaxel and hormone therapy as second line treatment in patients with mCRPC progressing after therapy with abiraterone or enzalutamide.
| Status | Active, not recruiting |
| Enrollment | 18 |
| Est. completion date | July 1, 2024 |
| Est. primary completion date | December 1, 2023 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Histologically or cytologically confirmed adenocarcinoma of the prostate - Distant metastatic disease - Previous first line treatment with abiraterone or enzalutamide for 6 cycles interrupted at least 2 weeks before randomization - Patients must be = 18 years of age - Patients must have castrate serum level of testosterone of < 0.5 ng/mL ( 1.7 nmol/L) - Asymptomatic or Oligosymptomatic disease - Progressive disease according to Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria - ECOG performance status (PS) of 0-2 - Sexually active males must use an accepted and effective method birth control measure - Written informed consent Exclusion Criteria: - Prior exposure to docetaxel or abiraterone for treatment of hormone-sensitive metastatic prostate cancer (mHSPC) - History of adrenal insufficiency or hypoaldosteronism - Any medical condition that would make prednisone use contraindicated - Any medical condition that would make docetaxel use contraindicated - Patients unable to swallow orally administered medication - Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV) requiring antiretroviral therapy - Other malignancy within the last 5 years, except for adequately treated non melanoma skin cancer, bladder cancer (pTis, pTa, pT1) or other solid tumours curatively treated with no evidence of disease for > 5 years - Participation in another clinical study with an investigational product within 30 days prior to randomization - Persistent toxicities [>Common Terminology Criteria for Adverse Event (CTCAE) grade 1)] caused by previous cancer therapy prior to randomization - Uncontrolled medical conditions including diabetes mellitus. Clinically significant cardiovascular disease (e.g.: uncontrolled hypertension or arrhythmia, unstable angina pectoris, congestive heart failure (CHF), vascular disease (arterial thrombosis) and myocardial infarction within < 6 months - Left ventricular ejection fraction < 50% - Peripheral neuropathy [> CTCAE grade 2] - Inadequate bone marrow function defined as: - haemoglobin < 9.0 g/dL - absolute neutrophils count (ANC) <1.5 x 109/L (> 1500 per mm3) - platelet count <100 x 109/L (>100,000 per mm3) - Inadequate renal and hepatic function, defined as: - total serum bilirubin > 1,0 x ULN - AST/SGOT o ALT/SGPT > 1,5 x ULN - calculated creatinine clearance < 40 mL/min - potassium level < 3,5 mmol/L - Child-Pugh class C |
| Country | Name | City | State |
|---|---|---|---|
| Italy | Istituto Nazionale dei Tumori , Oncologia Medica - Dipartimento Uro-Ginecologico | Napoli |
| Lead Sponsor | Collaborator |
|---|---|
| National Cancer Institute, Naples |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Overall survival (OS) | OS is defined as the time from randomization until death | up to 5 years | |
| Secondary | Progression free survival (PFS) | PFS is defined as the time elapsed from the date of randomization to the date of progression, as defined by investigators, or the date of death, whichever comes first. | up to 5 years | |
| Secondary | Time to Prostate-Specific Antigen (PSA) Progression | as determined by investigator | up to 5 years | |
| Secondary | Incidence of symptomatic skeletal events (SSE) | reporting the incidence and types of skeletal related events | up to 5 years | |
| Secondary | Time to symptomatic skeletal event (SSE) | Time from the date of randomization to the date of documented symptomatic skeletal event | up to 5 years | |
| Secondary | Time to Pain Progression | Time from the date of randomization to the date of pain progression | up to 5 years | |
| Secondary | Number of participants with treatment-related side effects as assessed by Common Terminology Criteria for Adverse Event (CTCAE) version 5.0 | graded according to Common Terminology Criteria for Adverse Event (CTCAE) version 5.0 | baseline, during treatment (every 4 weeks) up to 5 years | |
| Secondary | Determination of changes in quality of life | EORTC QLQ-C30, a quality of life questionnaires, composed by 30 items graded from1 (not at all) to 4 (very much) after 1 year from the diagnosis | baseline, during treatment up to 5 years | |
| Secondary | Radiographic response (bone lesions) | Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 | up to 5 years | |
| Secondary | Radiographic response (soft tissue lesions) | Prostate Cancer Working Group 3 (PCWG3) criteria | up to 5 years |