Assessment of treatment efficacy and adverse effects of Microrelin in patient with prostate cancer.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT201109067457N4

Enrollment

Registered

2011-10-09

Start date

2011-10-23

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate cancer. Malignant neoplasm of prostate

Interventions

Intervention 1: Intervention group: 20 patients with Microrelin (LHRH agonist) injection , 3.75 mg, Deep intramuscular injection, Every 28 days. Duration of assessment:18 months. Intervention 2: Cont

Treatment - Drugs

Intervention group: 20 patients with Microrelin (LHRH agonist) injection , 3.75 mg, Deep intramuscular injection, Every 28 days. Duration of assessment:18 months

Control group: 20 patients with Dipherelin - 3.75 mg - deep intramuscular injection - Every 28 days -Duration of assessment : 18 months

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1- High risk prostate cancer with PSA>20 and/or GS>=8 with extraprostatic extension and unsuitable for surgery. 2- Patients with bone metastases. 3- No history of surgery or radiotherapy for prostate cancer. 4- No history of other malignancy or consumption of other hormonal agents except microrelin. 5- Pelvic lymph node involvement . Exclusion criteria: 1- Surgery or raditherapy for prostate cancer. 2- Microrelin withdrawal 3- Coexistance of other malignancy.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Microrelin or Dipherelin consumption. Timepoint: Every 3 month. Method of measurement: Blood analysis.;Hemoglubin. Timepoint: Every 3 month. Method of measurement: Blood analysis.;Prostate Specific Antigen (PSA). Timepoint: Every 3 month. Method of measurement: Blood analysis.;Gleason score (GS). Timepoint: At the end of study. Method of measurement: Prostate biopsy.;SGOT. Timepoint: Every 3 month. Method of measurement: Blood analysis.;SGPT. Timepoint: Every 3 month. Method of measurement: Blood analysis.;Testosteron. Timepoint: Every 3 month. Method of measurement: Blood analysis.;Prolactin. Timepoint: Every 3 month. Method of measurement: Blood analysis.;LH. Timepoint: Every 3 month. Method of measurement: Blood analysis.;FSH. Timepoint: Every 3 month. Method of measurement: Blood analysis.;New changes in bone scan. Timepoint: Annual. Method of measurement: Whole body bone scan.;Alkp. Timepoint: Every 3 month. Method of measurement: Blood analysis.;Calcium. Timepoint: Every 3 month. Method of measurement: Blood analysis.;Phosphor. Timepoint: Every 3 month. Method of measurement: Blood analysis.	—

Measure

Time frame

Microrelin or Dipherelin consumption. Timepoint: Every 3 month. Method of measurement: Blood analysis.;Hemoglubin. Timepoint: Every 3 month. Method of measurement: Blood analysis.;Prostate Specific Antigen (PSA). Timepoint: Every 3 month. Method of measurement: Blood analysis.;Gleason score (GS). Timepoint: At the end of study. Method of measurement: Prostate biopsy.;SGOT. Timepoint: Every 3 month. Method of measurement: Blood analysis.;SGPT. Timepoint: Every 3 month. Method of measurement: Blood analysis.;Testosteron. Timepoint: Every 3 month. Method of measurement: Blood analysis.;Prolactin. Timepoint: Every 3 month. Method of measurement: Blood analysis.;LH. Timepoint: Every 3 month. Method of measurement: Blood analysis.;FSH. Timepoint: Every 3 month. Method of measurement: Blood analysis.;New changes in bone scan. Timepoint: Annual. Method of measurement: Whole body bone scan.;Alkp. Timepoint: Every 3 month. Method of measurement: Blood analysis.;Calcium. Timepoint: Every 3 month. Method of measurement: Blood analysis.;Phosphor. Timepoint: Every 3 month. Method of measurement: Blood analysis.

—

Secondary

Measure	Time frame
Flushing. Timepoint: Monthly. Method of measurement: Physical examination.;Bone pain. Timepoint: Monthly - Annualy. Method of measurement: Physical examination - Whole body bone scan.;Cardiovascular side effects. Timepoint: Every 3 month. Method of measurement: ECG analysis.;Anemia. Timepoint: Every 3 month. Method of measurement: Blood analysis.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Hossein Soltani

Urology and Nephrology Research Center (UNRC)

mohsenof20@yahoo.com+98 21 2256 7222

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026