Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Goserelin · 7 trials · 4 indications
The progression-free survival is the length of time during and after the treatment of a disease that a patient lives with the disease but it does not get worse.
The biological response is defined as a non-detectable serum PSA level (\<0.1 ng/ml)
Defined as a decrease of at least 20% in prostate volume detected by ultrasound after the neo-adjuvant treatment
The clinical progression-free survival is the length of time during and after the treatment of a disease that a patient lives with the disease but it does not get worse (based on bone scintigraphy, pelvic scan, or MRI evaluation).
The overall survival is the length of time from randomization that patients enrolled in the study are still alive. The outcome is to evaluate whether SRBT improves overall survival compared to standard of care.
The National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.0 (NCI-CTCAE v4.0) is widely accepted in the community of oncology research as the leading rating scale for adverse events. This scale, divided into 5 grades (1 = "mild", 2 = "moderate", 3 = "severe", 4 = "life-threatening", and 5 = "death") determined by the investigator, will make it possible to assess the severity of the disorders.
Developed by the EORTC, this self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials. The questionnaire includes five functional scales (physical, everyday activity, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), a health/quality of life overall scale, and a number of additional elements assessing common symptoms (including dyspnea, loss of appetite, insomnia, constipation, and diarrhea), as well as, the perceived financial impact of the disease. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
The number of participants for whom neither objective disease progression or death (due to any cause) has been observed at Week 24 over the number of randomised participants x 100.
ORR was determined as the sum of the Complete Response (CR) rate + Partial Response (PR) rates. * CR = Complete disappearance of all clinically- or pathologically-detectable malignant disease for at least 4 weeks. * PR = ≥ 50% decrease in tumor size for at least 4 weeks, without any new lesion or any ≥ 25% increase in size of any lesion. All measurements by ruler or calipers.
| Arm | Type | Description |
|---|---|---|
| Chemotherapy | EXPERIMENTAL | - |
| Without Chemotherapy | ACTIVE_COMPARATOR | - |
| 2 (CMF scheme) | EXPERIMENTAL | 6 cycles CMF scheme (cyclophosphamide, methotrexate, fluorouracil) |
| 1 (Nol + Zol) | EXPERIMENTAL | Zoladex (3 years) combined with Nolvadex (5 years) |
| Immediate ADT | OTHER | - |
| Deferred ADT | OTHER | - |
| I | ACTIVE_COMPARATOR | Exclusive Radiation Therapy 66 Gy (prostatic bed) / 46 Gy (Pelvis with lymph nod involvement) in treating patients who have undergone surgery for recurent or refractory Prostate Cancer |
| II | EXPERIMENTAL | Radiation Therapy 66 Gy (prostatic bed) / 46 Gy (Pelvis with lymph nod involvement) and GOSERELIN ACETATE in treating patients who have undergone surgery for recurent or refractory Prostate Cancer |
| ZOLADEX 10.8 mg | EXPERIMENTAL | ZOLADEX (goserelin acetate) 10.8 mg intramuscular depot for injection every 12 weeks |
| ZOLADEX 3.6 mg | EXPERIMENTAL | ZOLADEX (goserelin acetate) 3.6 mg intramuscular depot for injection every 4 weeks |
| 1 | EXPERIMENTAL | Zoladex 3-month depot |
| 2 | EXPERIMENTAL | Zoladex 1-month depot |
| Anastrozole + Goserelin | EXPERIMENTAL | Participants received goserelin 3.6 mg subcutaneously monthly. Beginning on Day 22 after the first dose of goserelin, participants began taking anastrozole 1 mg orally daily. No dose attenuation or escalation was allowed for either goserelin or anastrozole. |
| Name | Type | Description |
|---|---|---|
| bicalutamide | DRUG | - |
| Goserelin Acetate | DRUG | - |
| docetaxel | DRUG | - |
| Estramustine phosphate sodium | DRUG | - |
| acetylsalicylic acid | DRUG | - |
| conventional surgery | PROCEDURE | - |
| radiation therapy | RADIATION | - |
| Cyclophosphamide | DRUG | Cyclophosphamide 600mg/m2 |
| Methotrexate | DRUG | Methotrexate 40mg/m2 |
| Fluorouracil implant | DRUG | Fluorouracil 600mg/m2 |
| Goserelin | DRUG | Zoladex 3.6mg/28 days for 3 years |
| Tamoxifen | DRUG | Nolvadex 20mg/day for 5 years |
| adjuvant therapy | PROCEDURE | - |
| Anastrozole (Arimidex) | DRUG | Anastrozole is a prescription hormonal treatment that helps fight breast cancer by lowering the amount of estrogen in the body. It is a non-steroidal aromatase inhibitor, which significantly lowers serum estradiol (estrogen) concentrations, without interfering with the formation of adrenal corticosteroids or aldosterone |
| Goserelin (Zoladex) | DRUG | Goserelin is a palliative treatment of advanced breast cancer in pre- and perimenopausal women |
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the prostate * Locally advanced disease or at high risk for relapse * No clinically or radiologically suspected metastases * Prior lymphadenectomy required * Meets at least 1 of the following criteria for poor prognosis: * ...
Goserelin is used for the treatment of breast cancer, including advanced breast cancer and early-stage breast cancer, as well as prostate cancer. It is being studied in premenopausal women with hormone receptor-positive breast cancer to suppress estradiol levels. The drug is administered as a subcutaneous implant.
Goserelin is developed by AstraZeneca PLC, which is listed on the stock exchange under the ticker AZN. The company is conducting clinical trials to evaluate the drug's efficacy in various breast cancer indications, including advanced and early-stage breast cancer.
Goserelin is in Phase 2 clinical development for breast cancer indications. Clinical trials have been completed for advanced breast cancer and early-stage breast cancer. The drug is investigational and has not been approved by regulatory authorities for these uses.
Goserelin has been studied in several completed clinical trials, including NCT00186121 for metastatic breast cancer, NCT00303524 for early-stage breast cancer, NCT00309478 for early-stage breast cancer, and NCT00322348 for advanced breast cancer. These trials enrolled a total of 1,235 participants.
Goserelin is a small molecule that works by suppressing estradiol levels in premenopausal women. It acts on the pituitary gland to reduce the production of estrogen, which can help slow the growth of hormone receptor-positive breast cancer cells.