trelstar and Neoplasm-Metastasis

This study aimed to evaluate prognostic risk factors for cardiovascular events during treatment of metastatic prostate cancer patients with high-dose parenteral polyoestradiol phosphate (PEP, Estradurin®) or combined androgen deprivation (CAD) with special emphasis on pretreatment cardiovascular disease.. Nine-hundred and fifteen patients with T0-4, Nx, M1, G1-3, hormone- naïve prostate cancer were randomized to treatment with PEP 240 mg i.m. twice a month for 2 months and thereafter monthly, or to flutamide (Eulexin®) 250 mg per os three times daily in combination with either triptorelin (Decapeptyl®) 3.75 mg i.m. per month or on an optional basis with bilateral orchidectomy. Pretreatment cardiovascular morbidity was recorded and cardiovascular events during treatment were assessed by an experienced cardiologist. A multivariate analysis was done using logistic regression.. There was a significant increase in cardiovascular events during treatment with PEP in patients with previous ischaemic heart disease (p = 0.008), ischaemic cerebral disease (p = 0.002), intermittent claudication (p = 0.031) and especially when the whole group of patients with pretreatment cardiovascular diseases was analysed together (p < 0.001). In this group 33% of the patients had a cardiovascular event during PEP treatment. In the multivariate analysis PEP stood out as the most important risk factor for cardiac complications (p = 0.029). Even in the CAD group there was a significant increase in cardiovascular events in the group with all previous cardiovascular diseases taken together (p = 0.036).. Patients with previous cardiovascular disease are at considerable risk of cardiovascular events during treatment with high-dose PEP and even during CAD therapy. Patients without pretreatment cardiovascular morbidity have a moderate cardiovascular risk during PEP treatment and could be considered for this treatment if the advantages of this therapy, e.g. avoidance of osteopenia and hot flushes and the low price, are given priority.

Topics: Aged; Antineoplastic Agents, Hormonal; Cardiovascular Diseases; Combined Modality Therapy; Estradiol; Estrogens; Flutamide; Humans; Infusions, Parenteral; Male; Neoplasm Metastasis; Orchiectomy; Prognosis; Prostatic Neoplasms; Risk Factors; Triptorelin Pamoate

Triptorelin 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.. An 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.. In 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.. The 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).

Topics: Aged; Antineoplastic Agents, Hormonal; Delayed-Action Preparations; Hot Flashes; Humans; Injections, Intramuscular; Male; Middle Aged; Neoplasm Metastasis; Prostate-Specific Antigen; Prostatic Neoplasms; South Africa; Testosterone; Triptorelin Pamoate

To report the results of a trial comparing the efficacy of triptorelin and surgical castration in the treatment of locally advanced or metastatic prostate cancer.. 80 patients with previously untreated locally advanced or metastatic prostate cancer prostate cancer were included in a one-year multicentre, randomized, prospective, open-label therapeutic trial. Patients either received a monthly injection of triptorelin (group 1; n = 40), or were treated by pulpectomy (group 2; n = 40). Patients were reviewed every 3 months, then every 6 months.. The mean age of the patients was 71.22 +/- 8.25 years. At 1 month, 38 patients were castrated (plasma testosterone < 0.5 mg/ml) in the pulpectomy group versus 35 in the triptorelin group. The mean follow-up was 38.8 +/- 26 months in the triptorelin group and 36.3 +/- 25 months in the pulpectomy group. On multivariate analysis, age, impaired performance status and PAP level (> 3.2 ng/ml) were predictive factors of a poor outcome. The median survival was 37.5 +/- 9 months in the triptorelin group and 33 +/- 3 months in the pulpectomy group. At 3 years, no significant difference in specific survival was observed between the 2 groups. At 8 years of follow-up, 63 patients had died.. This study demonstrates an equivalent specific survival between patients treated by triptorelin or surgical castration. Castration is rapidly obtained with triptorelin (< 2 months) and is maintained over time throughout the duration of treatment.

Topics: Acid Phosphatase; Age Factors; Aged; Antineoplastic Agents, Hormonal; Follow-Up Studies; Forecasting; Humans; Male; Neoplasm Metastasis; Neoplasm Staging; Orchiectomy; Prospective Studies; Prostatic Neoplasms; Protein Tyrosine Phosphatases; Survival Rate; Testis; Testosterone; Treatment Outcome; Triptorelin Pamoate

Comparative efficacy and safety of 2 LHRH analogues in metastatic prostatic carcinoma.. 68 patients received monthly injections for 6 months (randomization): either subcutaneous leuprolide 3.75 mg LP (n = 36), or intramuscular triptorelin 3.75 mg LP (n = 32). (Flare-up prevention: nilutamide). Parameters re-evaluated at 1.3 and 6 months: centralized assays of plasma testosterone (T), LH and serum PSA; clinical symptoms. Main criterion: proportion of patients with T < or = 0.5 ng/mL.. The percentages of patients with T < or = 0.50 ng/mL was not significantly different between the two groups and were equal to 100 and 90%, 97 and 100%, and 100 and 96% at the 3 study times, for leuprolide or triptorelin, respectively. The difference was significant at 1 month on complementary analysis at the limit of T < 0.30 ng/mL: 86% with leuprolide versus 60% with triptorelin (p = 0.02) and for mean plasma testosterone: 0.16 +/- 0.10 ng/mL versus 0.33 +/- 0.44 ng/mL, respectively (p = 0.02). The clinical subjective efficacy was not significantly different.. Both treatments were effective, although plasma testosterone fell more rapidly with leuprolide. No conclusion about the possible clinical or survival benefits can be formulated. Overall safety was satisfactory.

Topics: Adenocarcinoma; Aged; Aged, 80 and over; Androgen Antagonists; Antineoplastic Agents; Antineoplastic Agents, Hormonal; Data Interpretation, Statistical; Drug Tolerance; Humans; Imidazoles; Imidazolidines; Injections, Intramuscular; Injections, Subcutaneous; Leuprolide; Male; Middle Aged; Neoplasm Metastasis; Prostate-Specific Antigen; Prostatic Neoplasms; Testosterone; Time Factors; Triptorelin Pamoate

One hundred and four patients were randomised for the study. Fifty-five were entered into the D-Trp-6-LHRH group and 49 into the orchiectomy group. All pre-treatment patient characteristics were similar and testosterone levels at 1 month or later were in the castrate range in both groups. Forty-six patients (83%) in the D-Trp-6-LHRH group and 40 (82%) in the orchiectomy group had a partial remission or stable disease at 3 months or later. There was no significant difference between the groups for response or survival. Three patients in the D-Trp-6-LHRH group had a disease "flare" in the first 10 days of treatment. The flare symptoms resolved by the end of 4 to 8 weeks. The incidence of flushing, decreased libido and impotence was similar in both groups. Although there was less psychological morbidity in the D-Trp-6-LHRH group the difference did not reach statistical significance. Our results indicate that long-acting D-Trp-6-LHRH offers a safe and highly effective alternative to orchiectomy.

Topics: Clinical Trials as Topic; Delayed-Action Preparations; Gonadotropin-Releasing Hormone; Humans; Male; Neoplasm Metastasis; Orchiectomy; Pain; Prostatic Neoplasms; Random Allocation; Triptorelin Pamoate; Urination Disorders

Safety and efficacy of a slow-release formulation of D-Trp-6-luteinising-hormone-releasing-hormone (D-Trp-6-LHRH) microcapsules were compared with orchidectomy in the initial treatment of advanced prostatic carcinoma. 41 patients were randomly assigned to D-Trp-6-LHRH and 38 to orchidectomy. Suppression of testosterone and reduction in prostatic acid phosphatase levels were similar in both groups. 87% of patients in the D-Trp-6-LHRH group and 81% in the orchidectomy group responded to treatment or showed no deterioration. Side-effects related to the decrease in testosterone were similar in both groups. 3 patients given D-Trp-6-LHRH had a disease "flare" in the first ten days of treatment which resolved completely when testosterone fell to castrate levels. Results of psychological assessment were similar in both groups before treatment, and on follow-up there was a weak trend towards decreased psychological morbidity in the hormone group. The slow-release preparation of D-Trp-6-LHRH microcapsules offers an important alternative in the management of advanced prostatic carcinoma.

Topics: Aged; Capsules; Delayed-Action Preparations; Follow-Up Studies; Gonadotropin-Releasing Hormone; Humans; Male; Middle Aged; Neoplasm Metastasis; Orchiectomy; Pain; Prostatic Neoplasms; Random Allocation; Testosterone; Triptorelin Pamoate; Urination Disorders

This study aims to assess the effectiveness of triptorelin on lower urinary tract symptoms (LUTS) in Algerian patients with non-localized prostate cancer in routine practice.. This prospective, observational, non-interventional, multicentre study was conducted in Algeria. Included patients who had locally advanced or metastatic prostate cancer and were treated with triptorelin 11.25mg given every 12 weeks. LUTS were evaluated with the International Prostate Symptom Score (IPSS) until week 48 after treatment initiation. An IPSS>7 indicated moderate to severe LUTS. The primary objective of the study was to determine the distribution of IPSS at week 48.. This study enrolled 193 patients at 21 centres. A total of 144 participants had IPSS available at baseline and after baseline (136 patients had moderate to severe LUTS and eight had mild LUTS at baseline). At week 48, amongst the 116 patients with IPSS available and moderate to severe LUTS at baseline, 94 (81.0%) had moderate to severe LUTS and 22 (19.0%) had mild LUTS. At week 48, the eight patients with mild symptoms at baseline remained in this category. The proportion of patient with severe LUTS decreased from 53.7% at baseline to 12.1% at week 48. Adverse events were reported in 22.9% of participants.. A reduction of LUTS is observed in patients with locally advanced or metastatic prostate cancer treated with triptorelin in routine practice. This is in agreement with similar observational studies of triptorelin conducted in other countries.. 4.

Topics: Aged; Aged, 80 and over; Algeria; Disease Progression; Humans; Injections, Intramuscular; Lower Urinary Tract Symptoms; Male; Middle Aged; Neoplasm Metastasis; Primary Health Care; Prostatic Neoplasms; Treatment Outcome; Triptorelin Pamoate

The relevance of drug treatment for prostate cancer increases with the number of patients who develop castration resistance. Currently, no unified treatment regimen for castration-resistant prostate cancer exists, but the standard treatment for these patients is continuous androgen deprivation therapy. This paper presents the experience of concomitant use of abiraterone acetate and triptorelin in patients with castration-resistant prostate cancer. Ten patients with disease duration of 1.5 to 18 years and established castration resistance are currently being followed up. Nine of ten patients have long-term bone metastases, one patient has visceral metastases. The combination therapy produced a significant PSA decrease in nine patients and regression of bone lesions in two patients.

Topics: Aged; Aged, 80 and over; Androstenes; Antineoplastic Combined Chemotherapy Protocols; Bone Neoplasms; Humans; Male; Middle Aged; Neoplasm Metastasis; Prostatic Neoplasms, Castration-Resistant; Triptorelin Pamoate

To assess the value of prostate-specific antigen (PSA) kinetics in predicting survival and relate this to the baseline variables in men with metastatic hormone-refractory prostate cancer (HRPC).. The data from 417 men with HRPC were included in a logistic regression model that included hemoglobin, PSA, alkaline phosphatase, Soloway score, and performance status pain analgesic score at baseline. The posttreatment variables included the PSA level halving time after the start of treatment, PSA level at nadir, interval to nadir, PSA velocity (PSAV), PSA doubling time after reaching a nadir, patient age, and treatment. These variables were added to the baseline model, forming new logistic regression models that were tested for net reclassification improvement.. The area under the receiver operating characteristics curve for the baseline model was 0.67. Of all variables related to PSA kinetics, the PSAV was the best predictor. The addition of PSAV to the baseline model increased the area under the receiver operating characteristics curve to 0.81. Only a moderate increase in the area under the receiver operating characteristics curve (0.83) was achieved by combining the baseline model in a multivariate model with PSAV, PSA doubling time, interval to nadir, and patient age at diagnosis of HRPC.. The PSAV alone gave a better prediction of survival value than all other PSA kinetics variables. By combining PSAV with the variables available at baseline, a better ground for treatment decision-making in men with HRPC can be achieved.

Topics: Aged; Aged, 80 and over; Androgen Antagonists; Antineoplastic Agents, Hormonal; Flutamide; Humans; Kinetics; Male; Neoplasm Metastasis; Orchiectomy; Predictive Value of Tests; Prostate-Specific Antigen; Prostatic Neoplasms; Survival Rate; Treatment Failure; Triptorelin Pamoate

Antitumoral effects of the agonist of luteinizing hormone-releasing hormone (D-Trp-6-LH-RH) and the somatostatin analog RC-160 (D-Phe-Cys-Tyr-D-Trp-Lys-Val-Cys-Trp-NH2) on chemically induced ductal pancreatic adenocarcinomas were studied. The tumors were induced in female Syrian golden hamsters by weekly s.c. injections of N-nitrosobis(2-oxopropyl)amine at a dose of 10 mg/kg b.w. for 6 weeks. 18 weeks after the last injection, the peptides in controlled-release microcapsule formulations were administered s.c. The animals received the following therapies: Group 1 (N = 15), vehicle only; Group 2 (N = 13), D-Trp-6-LH-RH microcapsules releasing 25 micrograms/day injected s.c. once a month; Group 3 (N = 14), RC-160 microcapsules, liberating 25 micrograms/day administered s.c. every 15 days; Group 4 (N = 14), the combination of D-Trp-6-LH-RH plus RC-160 microcapsules. The experiment was terminated on the 80th day when all hamsters in the control group were dead, but in the treated Groups 2, 3, and 4, we observed 71, 77, and 86% of survival rate, respectively. In addition to the prolongation of survival, the combination treatment resulted in a significant decrease in the tumorous pancreatic weight, increase in the body weight of the animals, reduction in ascites from 100 to 8.3% and regressive histological changes in 67% of the specimens. Our findings suggest that somatostatin analogues and D-Trp-6-LH-RH could be considered for the development of hormonal therapy for pancreatic cancer.

Topics: Animals; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Capsules; Cricetinae; Female; Gonadotropin-Releasing Hormone; Mesocricetus; Neoplasm Metastasis; Nitrosamines; Organ Size; Pancreatic Neoplasms; Somatostatin; Triptorelin Pamoate

Topics: Administration, Intranasal; Antineoplastic Agents; Biomarkers, Tumor; Buserelin; Delayed-Action Preparations; Gonadotropin-Releasing Hormone; Humans; Injections, Intramuscular; Luteinizing Hormone; Male; Neoplasm Metastasis; Prostatic Neoplasms; Testosterone; Triptorelin Pamoate

Topics: Acute Disease; Aged; Delirium; Gonadotropin-Releasing Hormone; Humans; Luteolytic Agents; Male; Neoplasm Metastasis; Pain; Prostatic Neoplasms; Triptorelin Pamoate