Trial reportClinical drug investigation2009
Triptorelin 6-month formulation in the management of patients with locally advanced and metastatic prostate cancer: an open-label, non-comparative, multicentre, phase III study.
Trial report in Clinical drug investigation, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00751790 (A Multicenter, Open, Non-comparative, Phase III Study on the Efficacy, Pharmacokinetics and Safety of Two Injections of Triptorelin Embonate 22.5 mg 6-month Formulation in Patients With Advanced Prostate Cancer.), which is not on this map. Cited by 24 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.
A Multicenter, Open, Non-comparative, Phase III Study on the Efficacy, Pharmacokinetics and Safety of Two Injections of Triptorelin Embonate 22.5 mg 6-month Formulation in Patients With Advanced Prostate Cancer.
Who cites it
24 citing papers in PubMed.
- Efficacy of Testosterone Suppression with Sustained-Release Triptorelin in Advanced Prostate Cancer.Advances in therapy · 2017Trial
- Efficacy and safety of leuprolide acetate 6-month depot for suppression of testosterone in patients with prostate cancer.Prostate cancer and prostatic diseases · 2012Trial
- Triptorelin associated adverse events evaluated using FAERS pharmacovigilance data.Scientific reports · 2025Article
- A Noninterventional, Cross-Sectional Study to Assess Patient Prostate Cancer Treatment Preferences and Experiences in Europe.Advances in therapy · 2025Article
- A 6-month sustained-release formulation of triptorelin for locally advanced or metastatic prostate cancer: a real-world experience in Asia.BMC urology · 2025Article
- The Therapeutic Mechanisms of Honey in Mitigating Toxicity from Anticancer Chemotherapy Toxicity: A Review.Journal of xenobiotics · 2024Review
- Testosterone nadir and clinical outcomes in patients with advanced prostate cancer: Post hoc analysis of triptorelin pamoate Phase III studies.BJUI compass · 2024Article
- Effectiveness, pharmacokinetics, and safety of triptorelin acetate microspheres in patients with locally advanced and metastatic prostate cancer.Therapeutic advances in medical oncology · 2024Article
- Targeting sex steroid biosynthesis for breast and prostate cancer therapy.Nature reviews. Cancer · 2023Review
- Machine learning in accelerating microsphere formulation development.Drug delivery and translational research · 2023Article
- Androgen-targeted therapy in men with prostate cancer: evolving practice and future considerations.Prostate cancer and prostatic diseases · 2019Review
- Effects of Initiating or Switching to a Six-Monthly Triptorelin Formulation on Prostate Cancer Patient-Healthcare Interactions and Hospital Resource Use: a Real-World, Retrospective, Non-Interventional Study.Oncology and therapy · 2018Article
- Triptorelin relieves lower urinary tract symptoms in Chinese advanced prostate cancer patients: a multicenter, non-interventional, prospective study.BMC urology · 2018Article
- Triptorelin for the relief of lower urinary tract symptoms in men with advanced prostate cancer: results of a prospective, observational, grouped-analysis study.Therapeutic advances in urology · 2017Article
- Effect of triptorelin on lower urinary tract symptoms in Australian prostate cancer patients.Research and reports in urology · 2017Article
- An Update on Triptorelin: Current Thinking on Androgen Deprivation Therapy for Prostate Cancer.Advances in therapy · 2016Review
- 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
- A prospective, observational grouped analysis to evaluate the effect of triptorelin on lower urinary tract symptoms in patients with advanced prostate cancer.Therapeutic advances in urology · 2015Article
- Comparison of the Efficacy of Two Brands of Triptorelin (Microrelin and Diphereline) in Reducing Prostate-Specific Antigen and Serum Testosterone in Prostate Cancer: A Double-Blinded Randomized Clinical Trial.Nephro-urology monthly · 2015Article
- Transplantation of bovine adrenocortical cells encapsulated in alginate.Proceedings of the National Academy of Sciences of the United States of America · 2015Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
17 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
objectivesTriptorelin 6-month formulation was developed to offer greater convenience to both patients and physicians by reducing the injection frequency. The efficacy, pharmacokinetics and safety of a new 6-month formulation of triptorelin were investigated over 12 months (48 weeks). The primary objective was to evaluate the formulation in achieving castrate serum testosterone levels (< or = 1.735 nmol/L or < or = 50 ng/dL) on day 29 and in maintaining castration at months 2-12. Absence of luteinizing hormone (LH) stimulation and change in prostate-specific antigen (PSA) level were also assessed.
methodsAn open-label, non-comparative, phase III study in 120 patients with advanced prostate cancer was conducted from July 2006 to August 2007 in private and public institutions in South Africa. Each patient received two consecutive intramuscular injections of triptorelin embonate (pamoate) 22.5 mg at an interval of 24 weeks. In all patients, testosterone (primary outcome measurement) was measured at baseline and then every 4 weeks; LH was measured before and 2 hours after the two injections. PSA was measured on day 1 and at weeks 12, 24, 36 and 48. Adverse events were recorded at each visit.
resultsIn the intent-to-treat population, 97.5% (95% CI 92.9, 99.5) of patients achieved castrate serum testosterone levels by day 29, and 93.0% (95% CI 86.8, 97.0) maintained castration at months 2-12. After the second injection, 98.3% of patients showed absence of LH stimulation. The most frequent drug-related adverse events were hot flushes (71.7% of patients). No patient withdrew from the study as a result of an adverse event.
conclusionsThe triptorelin 6-month formulation was well tolerated and was able to achieve and maintain castration for the treatment of locally advanced and metastatic prostate cancer. By reducing the frequency of required injections, this new formulation offers a more convenient treatment regimen. (Clinical Trial Registration,NCT00751790 at www.clinicaltrials.gov).
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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.