AMPLITUDE

Description

A phase 3, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of niraparib in combination with abiraterone acetate and prednisone (AA-P) and androgen deprivation therapy (ADT), versus abiraterone + prednisone + ADT in patients with metastatic castration-sensitive prostate cancer (mCSPC) with alterations in DNA repair genes (DNA repair defects or DRDs).

Target

The AMPLITUDE study aims to determine whether adding a new drug called niraparib to the standard treatment for advanced prostate cancer (abiraterone + prednisone + hormone therapy) can improve outcomes in men with certain genetic alterations in their DNA repair mechanisms.

• Standard treatment: abiraterone + prednisone + androgen deprivation therapy (ADT).
• New treatment under investigation: niraparib + abiraterone + prednisone + ADT.

All patients receive the standard treatment. Half of them also take niraparib (a new drug), while the other half take a placebo.

The goal is to determine whether this new combination helps better control the disease and prolong survival.

How the study is conducted

The trial is international, randomized (assigned at random), and double-blind (neither the patient nor the doctor knows which treatment each person is receiving). Participants are divided into two groups:

1. Group receiving niraparib + abiraterone + prednisone + ADT.
2. Group receiving a placebo (pill containing no active ingredient) + abiraterone + prednisone + ADT.

Study phases

1. Screening: A tumor sample is analyzed to determine whether the patient has a mutation in the DNA repair genes (a requirement for participation).
2. Screening: Medical tests and examinations are conducted to confirm that the patient meets the criteria.
3. Treatment: The patient takes the prescribed medication and undergoes follow-up imaging tests (CT scan, MRI, or bone scan) every 12 to 20 weeks.
4. Follow-up: Once treatment is complete, the patient continues to be monitored every 4 months to assess their progress.

To whom it is addressed

Men with:

• Confirmed diagnosis of metastatic prostate adenocarcinoma.
• That still respond to hormone therapy (medical or surgical castration).
• Who have a genetic mutation in their DNA repair mechanisms (such as BRCA1, BRCA2, ATM, etc.).
• Who have not previously received advanced treatments for this type of cancer (except for up to 6 cycles of docetaxel).

The following are excluded:

• Patients who have already received medications known as PARP inhibitors.
• Patients who have used other advanced hormonal therapies (enzalutamide, apalutamide, darolutamide, etc.).
• Patients with uncontrolled hypertension or other serious medical conditions.

Treatment

• Niraparib: 200 mg daily (by mouth).
• Abiraterone: 1000 mg daily (by mouth).
• Prednisone: 5 mg daily (by mouth).
  All medications are taken on a continuous basis, usually once a day.

Tracking and Security

The following will be monitored throughout the trial:

• Monitoring the progression of cancer through imaging tests.
• Possible side effects of the treatment.
• The patient's quality of life, as assessed through questionnaires.

If the tumor progresses or significant side effects occur, treatment is discontinued.

Duration

The duration may vary from patient to patient, but generally:

• Treatment continues as long as it is effective and well tolerated.
• Follow-up care may continue for up to a year after stopping the medication.