Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Leuprorelin acetate, Leuprorelin (GF), Leuprorelin SR, Enantone ®
Leuprorelin · 4 trials · 4 indications
Staging biopsy of at least 12 cores were sampled and analyzed according to a centralized biopsy procedure which confirm the results of the first biopsy \[presence of positive cores, the absence of core with tumor length \> 3 millimeters (mm), and absence Grade 4 cells (Gleason score \< 7)\]. The Gleason score grades prostate cancer tissue, based on its appearance under a microscope. Scores range from 2 to 10, with a higher score meaning that the cancer tissue is more likely to spread.
PFS=time from randomization to first documentation of progression (death, biological progression or clinical progression). PFS at Year 5=probability of participants' PFS at Year 5. Biological progression definition I: halfway point between nadir and first rise with prostate-specific antigen (PSA) ≥1 nanogram per milliliter (ng/mL) signifying progression and date of introduction of prostate treatment for all participants, including those leaving prematurely for reason other than progression/death; definition II: first date when PSA=nadir+2 ng/mL and date of introduction of prostate treatment, for participants leaving prematurely for reason other than progression/death. Clinical progression: local clinical progression-\>50% increase in prostate volume relative to lowest volume, recurrence of palpable prostatic tumor after complete regression, positive biopsy; locoregional progression=pelvic regional lymph node lesion development; metastatic progression=distant lesions identification.
Median Overall survival is defined as the number of days from date of inclusion to the date of death. For subjects who do not die, survival will be censored at the date of last contact.
Median Progression Free Survival=time from date of inclusion to date of first documentation of progressive disease (death, biological progression, clinical progression). Biological progression: date of the first PSA increase after the nadir and greater than or equal to (≥) 4 ng/mL under treatment. Clinical progression: date of appearance of the clinical sign of progression under treatment. Clinical signs of progression are: 1. Appearance of marked increase of bone pain or appearance of symptoms related to disease progression (example: liver, lungs, kidneys); 2. Alteration of general health conditions related to disease progression (decrease of at least 2 degrees in the European Organization for Research and Treatment of Cancer (ECOG) performance status, weight loss of more than 10% since the last visit); 3. Anemia - drop in hemoglobin level of more than 2 gram per deciliter (g/dL) since the last visit (only if disease related).
| Arm | Type | Description |
|---|---|---|
| Leuprorelin 11.25 mg | EXPERIMENTAL | Active surveillance after a single subcutaneous injection of leuprorelin 11.25 mg and bicalutamide 50 mg, tablet, orally, once daily, to prevent flare-up for 15 days. |
| Active surveillance | NO_INTERVENTION | Active surveillance is close medical monitoring of prostate cancer for any changes. |
| Combined Radiotherapy and Hormone Therapy | EXPERIMENTAL | Leuprorelin 11.25 milligram (mg) sustained release (SR), injection, subcutaneously, once every 3 months up to 3 years and flutamide 250 mg, tablet, orally, thrice daily for 30 days from the first dose of leuprorelin. Radiotherapy 70 +/- 4 Gray (Gy) in 35 fractions at a rate of 5 fractions of 2 Gy per week up to 3 years. An interval of a maximum of 2 weeks is authorized between radiation of the pelvis with 50 Gy (±4) (5 weeks) and radiation of the prostate with an additional 20 Gy. |
| Hormone Therapy alone | ACTIVE_COMPARATOR | Leuprorelin 11.25 mg SR, injection, subcutaneously, once every 3 months up to 3 years and flutamide 250 mg, tablet, orally, thrice daily for 30 days from the first dose of leuprorelin. |
| Leuprorelin (GF) | EXPERIMENTAL | - |
| Leuprorelin (GC) | EXPERIMENTAL | - |
| Continuous Therapy | ACTIVE_COMPARATOR | Continuous complete androgen suppression therapy with leuprorelin 3.75 mg sustained release (SR), injection, subcutaneously once every 28 days and flutamide, 250 mg, tablet, orally thrice daily until there are signs of disease progression. |
| Intermittent therapy | EXPERIMENTAL | Intermittent complete androgen suppression therapy starting at randomization with interruption of treatment given in the induction period until PSA levels reach \>=10 ng/mL or other signs of progression appear. Upon treatment resumption, leuproreline 3.75 mg SR, injection, subcutaneously once every 28 days and flutamide 250 mg, tablet, orally thrice daily, until PSA levels are \<normal (that is, \<4 ng/mL) and no signs of disease progression appear. The intermittent therapy will be continued similarly until the study end or the appearance of signs of disease progression under treatment. |
| Name | Type | Description |
|---|---|---|
| Leuprorelin | DRUG | Solution for injection |
| Bicalutamide | DRUG | Bicalutamide tablets |
| Leuprorelin SR | DRUG | Leuprorelin SR injection |
| Radiotherapy | RADIATION | Radiotherapy 70 +/- 4 Gy |
| Flutamide | DRUG | Flutamide tablets |
| Leuprorelin (GF) | DRUG | Leuprorelin (GF) 3.75 mg injection, subcutaneously, once every 4 weeks for up to 12 weeks. |
| Leuprorelin (GC) | DRUG | Leuprorelin (GC) 3.75 mg injection, subcutaneously, once every 4 weeks for up to 12 weeks. |
Inclusion Criteria: 1. Is an out-patient 50 to 80 years old. 2. Has read, understood, signed and dated the informed consent. 3. Has indolent prostate cancer defined by: * Clinical Stage T1c or T2a. * Biopsy cores of which at least 12 reveal the presence of positive cores and the absence of c...
Top 20 of 55 competitors
Leuprorelin is used to treat prostate cancer, including locally advanced prostatic neoplasms, and uterine fibroids. Clinical studies have evaluated it in indolent prostate cancer, in T3-T4 or pT3 N0 M0 prostate cancer combined with radiotherapy, in Stage D2 or TxNxM1b,c disease with flutamide, and in female subjects with uterine fibroids.
Leuprorelin is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the company associated with the Leuprorelin clinical development program across prostate cancer and uterine fibroids.
Leuprorelin is in Phase 3 clinical development. The Phase 3 studies include NCT02085252 in indolent prostate cancer and NCT01122121 in locally advanced prostate cancer. Earlier Phase 2 studies covered intermittent hormonal therapy in advanced prostatic neoplasms and a pharmacodynamic study in uterine fibroids.
Leuprorelin has been studied in completed trials including NCT02085252, a Phase 3 study of Enantone LP 11.25 mg in indolent prostate cancer, and NCT01122121, a Phase 3 comparison of Leuprorelin with radiotherapy versus Leuprorelin alone in locally advanced prostate cancer. Phase 2 trials include NCT00817739 and NCT00776074.
Yes, Leuprorelin acetate is an alternative name for Leuprorelin. Other names used for this agent include Leuprorelin (GF) and Leuprorelin SR. Searches for any of these names refer to the same drug developed by Takeda.
Leuprorelin trials have enrolled a total of 341 patients across the reported studies. Individual trial enrollment includes 116 patients in NCT02085252, 273 patients in NCT01122121, 341 patients in NCT00817739, and 80 patients in NCT00776074.