2. Methods and Materials
toxicity, toxicities, Toxicity, Cancer
DISEASE PROGRESSION, RECURRENCE, DISEASE, EVENT, DISEASE PROGRESSION, METASTASES, CANCER
Study design: The eligibility criteria are described in our previous publication [Evaluation of disease status: Patients underwent monthly visits for toxicities, physical examinations, and serum PSA, with baseline measurements taken prior to starting the P-MCP treatment protocol. A positron emission tomography (PET)—prostate-specific membrane antigen (PSMA) scan was conducted after 6 and 18 months in patients without clinical or PSA progression, or earlier upon clinical or PSA progression. The primary efficacy endpoint was the rate of patients without PSA progression (defined as an increase of ≥ 25% from baseline) and/or patients with improvement (lengthening) of PSADT versus baseline. The post-baseline PSADT was calculated using baseline PSA measurements obtained at the start of the study and every month during treatment. Secondary endpoints included the rate of patients without radiologic progression and toxicity, and with treatment benefits according to the PSADT risk grouping (e.g., poor < 3 months, intermediate 3–8.99 months, and good ≥9 months) [Duration of treatment: Treatment as per the protocol continued for 12 additional months or until biochemical or clinical disease progression or dose-limiting toxicity.Disease progression was defined as biochemical progression without PSADT prolongation and/or new radiological evidence of metastases.Safety evaluation of toxicity: Toxicity was defined according to the National Cancer Institute (NCI) Common Toxicity Criteria, with treatments terminated at grades 3/4 and patients monitored weekly until ≤grade 1 before restarting therapy. Treatment would be discontinued upon the recurrence of a same grade 3/4 event and for any toxicity requiring longer than 4 weeks to recover to ≤grade 1.Statistical analysis: Comparisons between pre- and post-treatment endpoint parameters, and within groups were analyzed using the Wilcoxon Signed Rank test for abnormally distributed data, or the two-tailed Student Regulatory Considerations: The research was conducted in accordance with the approval by the IRB committee of our institution. The study was registered at ClinicalTrials.gov (accessed on 10 September 2012) (NCT01681823).