Intermittent Versus Continuous Androgen Deprivation Therapy in Patients with Relapsing or Locally Advanced Prostate...

Area of Science:

• Oncology
• Urology
• Clinical Trials

Background:

• Limited data exists on intermittent androgen deprivation (IAD) versus continuous androgen deprivation (CAD) in nonmetastatic prostate cancer (PCa).
• The relative efficacy, safety, and quality of life (QoL) benefits of IAD compared to CAD remain unclear.

Purpose of the Study:

• To compare the efficacy and safety of IAD versus CAD in patients with nonmetastatic relapsing or locally advanced PCa.
• To evaluate potential benefits such as reduced side effects and improved QoL with IAD.

Main Methods:

• A 42-month, phase 3b, open-label, randomized study involving 933 patients across 20 European countries.
• Patients received a 6-month induction with leuprorelin acetate, followed by randomization to either CAD or IAD for 36 months.
• Primary endpoint: time to prostate-specific antigen (PSA) progression; secondary endpoints included PSA progression-free survival (PFS), overall survival (OS), testosterone levels, performance status, and QoL.

Main Results:

• 701 patients were randomized; no statistically significant or clinically relevant differences were observed between IAD and CAD groups in time to PSA progression, PSA PFS, OS, mean PSA levels, or QoL.
• Adverse events were similar between groups, with hot flushes and hypertension being most common.
• Study limitations include the open-label design and lack of formal testosterone recovery assessment.

Conclusions:

• IAD and CAD demonstrate comparable efficacy, tolerability, and QoL in men with nonmetastatic prostate cancer.
• The primary advantage of IAD over CAD is potential cost reduction with similar OS rates.
• No significant QoL benefits were observed with IAD compared to CAD.