metastatic prostate cancer hormone sensitive MedDRA version: 21.1 Level: PT Classification code 10036909 Term: Prostate cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10060862 Term: Prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Dexamethasone
Product Name: Dexamethasone
Pharmaceutical Form: Tablet
INN or Proposed INN: Dexamethasone
CAS Number: 50-02-2
Other descriptive name: Dexamethasone
Concentration unit: mg mi
Sponsors
SOGUG (Spanish Genitourinary Oncologic Group)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Informed consent. 2. Age equal to or older than 18 years. 3. Eastern Cooperative Oncology Group Performance Status (ECOG PS) or = 2 ng/mL. c. Documented progression after at least 12 weeks of treatment. 7. Blood testosterone levels 9 g/dL ii. Leukocytes > 2,000/mm 3 iii. Neutrophils > 1,000/mm 3 iv. Platelets > 75,000/mm 3 b. Hepatic: i. GOT 30 mL/min. 10. Absence of contraindication for administration of abiraterone acetate according to the data sheet. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 1. Radiological progression in the baseline radiological evaluation, according to RECIST and PCWG3 criteria. 2. Presence of clinically relevant symptomatology related to the disease, defined as: a. Significant pain (score > or = 3 on the Brief Pain Inventory - Short Form (BPI-SF), item 3). b. Presence of adverse effects > or = grade 2 that, in the judgment of the investigator, related to the baseline disease (adverse effects related to the toxicity of the related treatment will be accepted). 3. Biochemical, radiological or clinical progression in the 12 weeks since initiation of abiraterone + prednisone for the treatment of CPHSm. 4. Prior diagnosis of cancer, except: a. Patients diagnosed with a localized malignant tumor treated with curative intent, free of disease after curative intent, free of disease after 3 years. b. Patients diagnosed with skin tumors (of non-melanoma type) or intervened carcinomas in situ. 5. Any comorbidity that, in the judgment of the investigator, contraindicates the administration of dexamethasone as an adjuvant corticoid to treatment with abirateracetate with abiraterone acetate. 6. Medical, psychiatric or any other condition, which, in the investigator's judgment, would interfere with the interferes with the subject's ability to give informed consent, or safely carry out the procedures required in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the rate of PSA progression at 12 weeks in patients with metastatic HSCC who continue treatment with AA after biochemical progression in routine clinical practice and in whom the adjuvant prednisone is replaced by dexamethasone.;Secondary Objective: To compare, in patients with mCPHS who continue treatment with AA after biochemical progression within standard clinical practice and in whom the adjuvant prednisone is replaced by dexamethasone: a) The response rate by PSA b) Progression-free survival c) Overall survival d) Toxicity profile;Primary end point(s): Rate or proportion of patients with progression by PSA;Timepoint(s) of evaluation of this end point: At progression | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Rate or proportion of patients with PSA response - Radiologic progression-free survival - Radiological response rate - Clinical progression-free survival - Overall survival - Toxicity;Timepoint(s) of evaluation of this end point: Toxicity: throughout the trial. The rest, at the time of progression. | — |
Countries
Spain
Contacts
Public ContactSecretaría SOGUG
SOGUG (Spanish Genitourinary Oncologic Group)
Outcome results
None listed