The FDA has approved a new combination treatment—niraparib plus abiraterone acetate (Akeega) taken with low‑dose prednisone—for adults with metastatic castration‑sensitive prostate cancer (mCSPC) whose tumors have a harmful BRCA2 gene change, confirmed by a specialized test. This means some men with a BRCA2‑positive cancer now have a targeted option added to standard hormone‑blocking treatment to help keep the disease under control for longer.
What Did the AMPLITUDE Study Show?
In the AMPLITUDE clinical trial, men with BRCA2‑mutated mCSPC who received niraparib together with abiraterone and prednisone went longer before their cancer worsened on scans compared with those who received abiraterone, prednisone, and a placebo. In this BRCA2‑positive group, many men on the combination had not yet reached the average (median) time until their cancer progressed, while those on placebo plus abiraterone had progression at around 26 months. The benefit from adding niraparib was not seen in men whose cancers did not have BRCA2 mutations, underscoring how important BRCA2 testing is in deciding whether this regimen is likely to help.
Who Was in the Trial?
The study included men whose prostate cancer had spread (metastatic), was still sensitive to hormone‑lowering therapy, and had changes in certain DNA‑repair genes (including BRCA2). Everyone received standard androgen‑deprivation therapy plus daily prednisone, and then was randomly assigned to get either niraparib plus abiraterone or abiraterone with a placebo. The main question was how long men lived before their cancer progressed on scans; researchers also looked at overall survival and how long it took for symptoms to worsen.
Survival and Symptom Control
In the group with BRCA2‑mutated cancer, fewer deaths were seen so far in men who received niraparib plus abiraterone and prednisone than in those who received abiraterone and prednisone alone. The combination also delayed the time until symptoms from prostate cancer got worse, suggesting it may help some men feel better for longer while keeping the disease under better control.
Side Effects and Monitoring
Like many cancer treatments, this combination can cause side effects and often requires dose changes or short treatment breaks. Common side effects included high blood pressure, muscle or bone pain, constipation, fatigue, nausea, and infections such as respiratory tract infections. Some men also experienced heart rhythm changes, dizziness, hot flashes, diarrhea, decreased appetite, and weight loss. Blood tests frequently showed anemia (low red blood cells), low platelets, low lymphocytes, and changes in electrolytes and liver or kidney tests.
Because of these possible effects, men taking niraparib with abiraterone and prednisone usually need:
- Regular blood pressure checks
- Frequent blood tests to monitor blood counts and organ function
- Close reporting of symptoms such as chest pain, shortness of breath, palpitations, increased fatigue, bleeding, or signs of infection
Anyone considering this treatment should talk with their oncology and urology team about genetic testing for BRCA2 and other DNA‑repair genes, the potential benefits of the combination, and whether the side‑effect profile is a good fit for their overall health and goals of care.
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