Metastatic prostate cancer. Malignant neoplasm of prostate
Conditions
Interventions
Intervention 1: Leupromer 7.5mg every 28 day for 3 times. Intervention 2: Eligard 7.5mg every 28 day for 3 times.
Treatment - Drugs
Leupromer 7.5mg every 28 day for 3 times
Eligard 7.5mg every 28 day for 3 times
Sponsors
Iran Polymer and petrochemical institute
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1-Paetient with metastatic prostate cancer who examined by paraclinical diagnostics. (i.e.: needle biopsy of prostate, pathologic trans rectal sonography bone scan, CT-scan and MRI) and assessd their bone and viscera; 2- Must be Iranian; 3-Signed the testimonial form by own awareness. 4-Confidency of patient cooperation with administering drug; 5-Assitance of patient to come with scheduled program. Exclusion criteria: 1-Disorder in hypothalamus-hypophysis-gonadal axis; 2-Previous treatment with GnRH analog or other hormonal treatment or chemotherapy in last three month; 3-Radioteraohy in last two month; 4-Malignant with active origin; 5-Need to adjuvant treatment; 6-Urinary obstruction or spinal cord compression; 7- Administering with other drug (cooperating with another study); 8- Dissatisfaction of patient; 9-Probability of impossibility of following by patient; 10-drug addiction; 11- allergy to GnRH analogs or any kind of GnRH.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ratio of serum PSA level regarding to baseline. Timepoint: 28, 56 and 84 day after beginning of treatment. Method of measurement: PSA tumor marker (ng/ml). | — |
Secondary
| Measure | Time frame |
|---|---|
| Testosterone serum level. Timepoint: 28, 56 and 84 day after beginning of treatment. Method of measurement: Testosterone blood level (ng/dl).;LH serum level. Timepoint: 28, 56 and 84 day after beginning of treatment. Method of measurement: LH blood level (IU/L).;Side effect frequency. Timepoint: Three month after beginning day of treatment. Method of measurement: Examination and following treatment.;Bone pain decreasing frequency. Timepoint: Three month after beginning day of treatment. Method of measurement: Examination and following treatment based on 1-10 score.;Frequency of reduction in urinary pain. Timepoint: Three month after beginning day of treatment. Method of measurement: Examination and following treatment based on 1-10 score.;Frequency of reduction in urinary symptom. Timepoint: Three month after beginning day of treatment. Method of measurement: Examination and following treatment based on 1-10 score. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Hasanzade
Shahid Beheshti University of Medical Sciences
Outcome results
None listed