From the Guidelines
Yes, Androgen Deprivation Therapy (ADT) plus apalutamide (Erleada) should be continued when starting LU 117 therapy for metastatic prostate cancer. The most recent and highest quality study, the NCCN clinical practice guidelines in oncology 1, recommends the use of ADT with treatment intensification for patients with metastatic castration-sensitive prostate cancer, and the use of ADT monotherapy in this setting is discouraged unless there are clear contraindications to combination therapy. The guidelines suggest that treatment intensification options include doublet therapy of ADT with abiraterone, apalutamide, or enzalutamide, and that these doublet therapies are all category 1, preferred options. Given that apalutamide works through a different mechanism than LU 117, providing complementary anti-tumor activity by blocking androgen receptor signaling, it is reasonable to continue apalutamide along with ADT when starting LU 117 therapy. Some key points to consider when making this decision include:
- The importance of maintaining castrate testosterone levels when using radioligand therapy
- The potential for synergistic effects between ADT, apalutamide, and LU 117 in targeting prostate cancer cells through different pathways
- The need to minimize the risk of tumor progression through mechanisms not addressed by the radioligand therapy alone. It is also worth noting that older guidelines, such as the AUA guideline from 2013 1, may not be directly applicable to this specific clinical scenario, and that more recent and higher-quality evidence should be prioritized when making treatment decisions.
From the FDA Drug Label
Patients should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had a bilateral orchiectomy.
The FDA drug label does not answer the question about continuing ADT plus apalutamide when starting LU 117, as there is no mention of LU 117 in the label.
From the Research
Continuing ADT plus Apalutamide when Starting LU 117
There are no direct research papers to assist in answering this question. However, we can look at the available evidence on the use of apalutamide in combination with Androgen Deprivation Therapy (ADT) in patients with advanced prostate cancer.
- The studies 2, 3, 4, 5, 6 discuss the efficacy and safety of apalutamide in combination with ADT in various clinical settings, including metastatic hormone-sensitive prostate cancer (mHSPC) and non-metastatic castration-resistant prostate cancer (nmCRPC).
- These studies suggest that apalutamide plus ADT is an effective and well-tolerated treatment option for patients with advanced prostate cancer, regardless of age or disease volume.
- However, none of these studies specifically address the question of continuing ADT plus apalutamide when starting LU 117.
Key Findings
- Apalutamide plus ADT has been shown to improve overall survival and radiographic progression-free survival in patients with mHSPC and nmCRPC 2, 3, 6.
- The treatment is well-tolerated, with manageable side effects that do not impact health-related quality of life compared to ADT alone 2, 5.
- The efficacy and safety of apalutamide plus ADT have been demonstrated in various patient subgroups, including those with high-volume disease, synchronous or metachronous metastases, and oligometastatic disease 6.