Apalutamide for prostate cancer: Multicentre and multidisciplinary real-world study of 227 patients.

OBJECTIVE: To evaluate the efficacy and safety of apalutamide prostate cancer compared to the pivotal trials patients and to identify the first subsequent therapy in a real-world setting. METHODS: The study is prospective and observational based on real-world evidence, performed by different medical disciplines and eight academics centres around Barcelona, Spain. It included all patients with metastatic hormone-sensitive prostate cancer (mHSPC) and high-risk non-metastatic castration-resistant prostate cancer (nmCRPC) treated with apalutamide from June 2018 to December 2022. RESULTS: Of 227 patients treated with apalutamide, 10% had ECOG-PS 2, and 41% were diagnosed with new-generation imaging. In the mHSPC group (209 patients), 75 years was the median age, 53% had synchronous metastases, and 22% were M1a. In the nmCRPC (18 patients), 82 years was the median age, and 81% ≤6 months had PSA doubling time. Patients achieved PSA90 in 92% of mHSPC and 50% of nmCRPC and PSA ≤0.2 in 71% of mHSPC and 39% of nmCRPC. Treatment-related adverse events occurred in 40.1% of mHSPC and 44.4% of nmCRPC. After discontinuation of apalutamide due to disease progression, 54.5% in mHSPC and 75% in nmCRPC started chemotherapy, while after discontinuation because of adverse events, 73.3% in mHSPC and 100% in nmCRPC continued with other hormonal-therapies. CONCLUSIONS: The efficacy and safety of apalutamide were similar to that described in the pivotal trials, despite including an older and more comorbid population. Usually, subsequent therapies after apalutamide differed depending on the reason for discontinuation: by disease progression started chemotherapy and by adverse events hormonal sequencing.

Low testosterone bioavailability is related to prostate cancer diagnose in patients submitted to prostate biopsy.

INTRODUCTION: Relationship between prostate cancer (PCa) and testosterone (T) is controversial. Conflicting evidence has been published about T levels and development of PCa. AIM: (1) To determine the relationship between hormone levels and the diagnosis of PCa. (2) To specifically focus on the relationship between PCa and T in men classified as biochemically hypogonadal. MATERIALS AND METHODS: Prospective analysis of 1,000 transrectal ultrasound guided prostate biopsies (5 + 5 cores biopsies) between September 2007 and January 2010 in one center. Indication for prostate biopsy was suspicion of PCa on the basis of elevated prostate-specific antigen (PSA) and/or digital rectal examination (DRE). Serum testosterone and sex hormones binding globulin (SHBG) were determined in these patients. Of 557 men, the data were sufficient for further analysis. Age, body mass index (BMI), smoking/drinking habits, PSA, free PSA, PSA density, prostate volume, number of previous biopsies, DRE, and hormone levels were prospectively recorded. RESULTS: No relationship was found between T and PCa (449 ± 167 ng/dL in PCa versus 437 ± 169 ng/dL in non-PCa). SHBG was significantly higher in patients with PCa (51 ± 27 ng/dL in PCa vs. 44 ± 18 ng/dL in non-PCa). In hypogonadal men, T levels correlated with the PCa (235 ± 95 ng/dL in men with PCa versus 270 ± 58 ng/dL in men without PCa, P = 0.004). CONCLUSIONS: T levels were comparable in men with and without PCa, but SHBG levels were significantly higher in men with PCa. In men with low T, the men with PCa had a lower serum T levels and a lower prostate volume than the men without PCa.