What should the treatment plan be for a patient with a declining PSA from 0.2 to 0.17 after starting ADT and apalutamide?

From the Guidelines

The treatment plan for a patient with a declining PSA from 0.2 to 0.17 after starting ADT and apalutamide should continue with the current regimen as this represents an appropriate response to therapy. The patient should maintain their androgen deprivation therapy (typically a GnRH agonist/antagonist like leuprolide or degarelix) along with apalutamide at the standard dose of 240 mg daily, as supported by the recent guideline update 1. Regular PSA monitoring should occur every 3 months to ensure continued response, with imaging reserved for PSA rises or new symptoms. Laboratory monitoring should include complete blood counts, liver function tests, and metabolic panels every 3 months, along with testosterone levels to confirm castrate levels (<50 ng/dL). The declining PSA indicates the treatment is effectively suppressing androgen-sensitive prostate cancer cells, as apalutamide blocks androgen receptors while ADT reduces testosterone production. This combination therapy provides more complete androgen blockade than ADT alone, which explains the favorable PSA response, as demonstrated in the SPARTAN trial 1. Side effect management should include monitoring for fatigue, hot flashes, falls, fractures, and cardiovascular events, with appropriate supportive care as needed.

Some key points to consider in the management of this patient include:

• The importance of continuing the current regimen given the evidence of its efficacy in improving metastasis-free survival and overall survival in patients with non-metastatic castration-resistant prostate cancer 1.
• The need for regular monitoring of PSA levels and imaging studies to assess response to therapy and detect potential progression early.
• The management of side effects, which can include fatigue, hot flashes, and cardiovascular events, to ensure the patient can tolerate the treatment and maintain their quality of life.
• The consideration of updated treatment recommendations, such as those from the ESMO clinical practice guideline, which support the use of apalutamide in combination with ADT for patients with non-metastatic castration-resistant prostate cancer 1.

Overall, the current treatment plan is appropriate, and continuation of ADT and apalutamide, along with regular monitoring and management of side effects, is recommended based on the latest evidence and guidelines.

From the FDA Drug Label

Apalutamide 240 mg daily in addition to ADT in patients with mCSPC (TITAN) reduced PSA to undetectable levels (<0.2 ng/mL) in 68% of patients compared to 32% of patients taking ADT alone. The exposure-response relationship and time course of pharmacodynamic response for the safety and effectiveness of apalutamide have not been fully characterized

The patient's PSA level has declined from 0.2 to 0.17 after starting ADT and apalutamide. Continuation of current treatment is recommended, as the patient is showing a response to the therapy.

• The treatment plan should be to continue ADT and apalutamide as the patient's PSA level is declining.
• Monitoring of PSA levels should be continued to assess the patient's response to treatment.
• No changes to the treatment plan are recommended at this time, as the patient is showing a positive response to the current therapy 2.

From the Research

Treatment Plan

The patient's PSA levels have declined from 0.2 to 0.17 after starting ADT and apalutamide, indicating a positive response to treatment. Based on the studies, the following points should be considered:

• A deep PSA response (≥90% PSA reduction or PSA ≤0.2 ng/ml) is associated with improved time to PSA progression, metastasis-free survival, and overall survival 3, 4, 5.
• The achievement of a deep PSA decline at landmark 3 months of apalutamide treatment is associated with longer overall survival, radiographic progression-free survival, time to PSA progression, and time to castration resistance 4, 5.
• Apalutamide plus ADT has been shown to produce rapid, deep, and durable PSA responses in patients with metastatic castration-sensitive prostate cancer, which are associated with improved clinical outcomes 3, 4, 6, 7.

Considerations for Treatment Plan

The following considerations should be taken into account when determining the treatment plan:

• The patient's PSA levels have declined, but it is essential to continue monitoring PSA levels to assess the treatment's effectiveness.
• The patient is currently receiving ADT and apalutamide, which has been shown to be an effective combination in improving overall survival and delaying castration resistance 3, 4, 6, 7.
• The treatment plan should be individualized based on the patient's response to treatment, overall health, and other factors.

Key Points

• The patient's PSA decline is a positive response to treatment.
• Continued monitoring of PSA levels is essential to assess treatment effectiveness.
• The combination of ADT and apalutamide has been shown to be effective in improving overall survival and delaying castration resistance 3, 4, 6, 7.