2.2. Patients
Tumor, cancer, adenocarcinoma of the prostate, prostate, psychiatric, alcohol abuse, Liver or renal function, N0
METASTASIS, TUMOR, CANCER, DISEASE, ADENOCARCINOMA OF THE PROSTATE, PROSTATE, METASTASIS, PROSTATE CANCER
The eligibility criteria were the same for all the trials:Inclusion criteria
Histologically proven adenocarcinoma of the prostate;Androgen deprivation therapy suitable (advanced prostate cancer, i.e., with local invasion or/and metastasis);Signed written informed consent.Exclusion criteria
Liver or renal function tests (ASAT/SGOT, ALAT/SGPT, total bilirubin, creatinine) exceeding twice the upper limit of the normal range, unless the elevation is attributed to hepatic metastasis;Any contraindication to the use of Teverelix DP;Life expectancy of less than 1 year;Baseline testosterone value below 2.31 ng/mL;Bilateral orchidectomy;Pre-existing hormone therapy or planned concomitant use of androgen deprivation therapy with any agent other than the investigational drug;Neurological, psychiatric disease, drug or alcohol abuse which could interfere with the subject’s proper compliance;Evidence of concurrent malignancy;Exposure to another investigational agent within the last month;Lack of ability or willingness to give informed consent;Anticipated non-availability for study visits/procedures.The subject populations were male patients with histologically proven adenocarcinoma of the prostate and for whom ADT was considered suitable (advanced prostate cancer, i.e., with local invasion and/or metastasis as staged by the Tumor, Nodes, Metastisis (TNM) scale (see below)). Patient demographics are detailed in The TNM system is a way of staging prostate cancer. It stands for Tumor, Node, Metastasis. Tumor (T) describes the size or area of the cancer. There are 4 main T stages of prostate cancer–T1 to T4.T1 means the cancer is too small to be seen on a scan or felt during an examination of the prostate.T2 means the cancer is completely inside the prostate gland.T3 means the cancer has broken through the capsule of the prostate gland.T4 means the cancer has spread into other body organs nearby, such as the back passage, bladder, or the pelvic wall.Node (N) describes whether the cancer has spread to the lymph nodes with N0 meaning that the nearby lymph nodes do not contain cancer cells and N1 means there are cancer cells in the lymph nodes near the prostate. NX means that the cancer in nearby lymph nodes cannot be measured.Metastasis (M) describes whether the cancer has spread to a different part of the body, and there are two M stages: M0 and M1. M0 means the cancer has not spread to other parts of the body. M1 means the cancer has spread to other parts of the body outside the pelvis.