Apalutamide Monotherapy in Metastatic Hormone-Sensitive Prostate Cancer: a Viable Alternative to First Generation Anti-Androgen Agents to Avoid the Flare Phenomenon and an Effective Treatment to Achieve Early PSA Response

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Abstract

Background/Objectives. Androgen Deprivation Therapy (ADT) is the mainstay of prostate cancer treatment, especially in the advanced disease. In particular, the Gonadotropin-Releasing Hormone agonists (aGnRH) reduce the production of gonadotropin and, therefore, testosterone. In about 10% of patients, the non-pulsatile stimulation of GnRH receptor initially causes a surge in LH and testosterone, defined “flare-up phenomenon”, leading to increased bone pain, spinal cord compression, bladder outlet obstruction and cardiovascular issues. To mitigate this effect, combining a First Generation Antiandrogen agent (FGA) with aGnRH is recommended. However, second-generation Anti-androgens, as apalutamide, bind selectively and irreversibly to the Androgen Receptor (AR), exhibiting a more efficient inhibition of the AR pathway. Methods. This is a descriptive retrospective study of 27 patients (pts) with mHSPC, treated at a single centre “Santa Maria delle Grazie” Hospital in Pozzuoli, ASL Napoli 2 Nord, Italy, between June 2022 and April 2024. Pts received apalutamide monotherapy for 14 days followed by continuous combination with aGnRH plus apalutamide. Serum PSA and testosterone levels were measured at baseline, at day 14 (after 13 days of apalutamide monotherapy), at day 28 (after additional 15 days of apalutamide plus a aGnRH), and at day 60. Results. PSA levels decreased from a mean of 45.2 (±63.1) ng/ml at baseline to a mean of 12.6 (±23.4) ng/ml at day 14 and to 3.3 ng/ml (±6.0) at day 28 of treatment. After 14 days of apalutamide monotherapy, 21 patients (77.8%) achieved a >50% PSA reduction and 4 (14.8%) a >90% PSA reduction. The number of patients with undetectable PSA was 1 (3.7%) at day 14, 2 (7.4%) at day 28 and 9 (33.3%) at day 60. The mean serum testosterone levels were 6.56 (± 4.46) ng/ml at baseline, 6.58 (± 4.42) ng/ml at day 14, and 2.40 (± 3.38) ng/ml at day 28. No significant difference in PSA and testosterone levels reduction during treatment emerged between subgroups of patients with low vs. high volume disease. Conclusions. Apalutamide alone is a viable option for mitigating the flare up phenomenon avoiding first generation Anti-androgen therapy, and it is able to achieve a rapid and deep biochemical control.

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