Trial reportProstate cancer and prostatic diseases2012
Efficacy and safety of leuprolide acetate 6-month depot for suppression of testosterone in patients with prostate cancer.
Trial report in Prostate cancer and prostatic diseases, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
21 citing papers in PubMed, 50 citations in OpenAlex.
- A population K-PD model analysis of long-term testosterone inhibition in prostate cancer patients undergoing intermittent androgen deprivation therapy.Journal of pharmacokinetics and pharmacodynamics · 2021Trial
- A phase 3, open-label, multicenter study of a 6-month pre-mixed depot formulation of leuprolide mesylate in advanced prostate cancer patients.World journal of urology · 2020Trial
- Efficacy of switching therapy of luteinizing hormone-releasing hormone analogue for advanced prostate cancer.The Kaohsiung journal of medical sciences · 2016Trial
- Efficacy and safety of leuprorelin acetate 6-month depot in prostate cancer patients: a Phase III, randomized, open-label, parallel-group, comparative study in Japan.Japanese journal of clinical oncology · 2015Trial
- A semi-mechanistic integrated pharmacokinetic/pharmacodynamic model of the testosterone effects of the gonadotropin-releasing hormone agonist leuprolide in prostate cancer patients.Clinical pharmacokinetics · 2015Trial
- Meningioma enlargement associated with luteinizing hormone-releasing hormone agonist therapy: two cases and supporting in vitro evidence.Brain tumor pathology · 2026Article
- Redefining long-acting injectables: the emerging role of extracellular vesicles in sustained drug delivery.Drug delivery and translational research · 2026Review
- Effect of Vitamin K Supplementation on Testosterone Production in a Rat Model of Late-Onset Hypogonadism.Foods (Basel, Switzerland) · 2026Article
- Leveraging Model-Based Simulations to Optimize Extended Dosing of Leuprolide 6-Month Intramuscular Depot Formulation.European journal of drug metabolism and pharmacokinetics · 2025Article
- A disproportionality analysis of adverse events caused by GnRHas from the FAERS and JADER databases.Frontiers in pharmacology · 2024Article
- Effectiveness, pharmacokinetics, and safety of triptorelin acetate microspheres in patients with locally advanced and metastatic prostate cancer.Therapeutic advances in medical oncology · 2024Article
- Clinical development of the GnRH agonist leuprolide acetate depot.F&S reports · 2023Article
- Leveraging the therapeutic, biological, and self-assembling potential of peptides for the treatment of viral infections.Journal of controlled release : official journal of the Controlled Release Society · 2022Review
- Androgen-targeted therapy in men with prostate cancer: evolving practice and future considerations.Prostate cancer and prostatic diseases · 2019Review
- Pharmacokinetic and pharmacodynamic comparison of subcutaneousTherapeutic advances in urology · 2018Article
- Intramuscular depot formulations of leuprolide acetate suppress testosterone levels below a 20 ng/dL threshold: a retrospective analysis of two Phase III studies.Research and reports in urology · 2016Article
- Efficacy of triptorelin pamoate 11.25 mg administered subcutaneously for achieving medical castration levels of testosterone in patients with locally advanced or metastatic prostate cancer.Therapeutic advances in urology · 2015Article
- Interventions for cough in cancer.The Cochrane database of systematic reviews · 2015Article
- Leuprolide acetate 1-, 3- and 6-monthly depot formulations in androgen deprivation therapy for prostate cancer in nine European countries: evidence review and economic evaluation.ClinicoEconomics and outcomes research : CEOR · 2013Article
- Six-month leuprorelin acetate depot formulations in advanced prostate cancer: a clinical evaluation.Clinical interventions in aging · 2013Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThis open-label study evaluated the efficacy and safety of a new leuprolide acetate 45 mg 6-month depot formulation in 151 men with prostate cancer who received 2 intramuscular injections administered 24 weeks apart.
methodsThe primary efficacy measurement was the proportion of patients achieving suppression of serum testosterone to ≤ 50 ng dl(-1) from week 4 through week 48. Adverse events (AEs) and hormonal and safety laboratory values were monitored.
resultsThe primary efficacy end point was achieved in 93.4% of subjects (95% confidence interval (89.2%, 97.6%)). There were nine escapes from testosterone suppression during the study, none of which were accompanied by a rise in PSA. By week 4, mean testosterone concentration was suppressed below castrate levels to 15.9 ng dl(-1); suppression was maintained for the entire 24-week duration of each depot injection. No mean increase in testosterone was observed after the second injection. Mean PSA levels were maintained below 3 ng ml(-1) from week 14 through the 48-week treatment period. The most frequent AE was flushing (58.3%). Injection site reactions were reported in 24.5% of patients.
conclusionsLeuprolide acetate 45 mg 6-month depot demonstrated rapid and sustained testosterone suppression through 12 months and was well tolerated. This 6-month leuprolide acetate depot will decrease the number of annual injections in the treatment of prostate cancer.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.