trelstar and nilutamide
trelstar has been researched along with nilutamide* in 6 studies
Trials
4 trial(s) available for trelstar and nilutamide
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Evaluation of antiandrogen therapy in unresectable hepatocellular carcinoma: results of a European Organization for Research and Treatment of Cancer multicentric double-blind trial.
The aim of the study was to evaluate the efficacy of antiandrogen therapy on overall survival and response in unresectable hepatocellular carcinoma (HCC).. A total of 244 patients with unresectable HCC were included in this multicentric double-blind trial. According to a two-by-two factorial design, patients were randomly assigned to receive one of the following treatments: pure antiandrogen plus placebo (A+P group, 60 patients); luteinizing hormone-releasing hormone (LHRH) agonist plus placebo (LHRH+P group, 62 patients); pure antiandrogen plus LHRH agonist (A+LHRH group, 62 patients); or placebo plus placebo (P+P group, 60 patients). Pure antiandrogen consisted of Anandron (Roussel-Uclaf Laboratory, Romainville, France) administered orally (300 mg daily for 1 month, then 150 mg daily). LHRH consisted of goseriline acetate (3.6 mg) or triptoreline (3.75 mg) administered monthly by subcutaneous injection. Treatment was given until death. Response was evaluated every 8 weeks according to World Health Organization (WHO) criteria.. Six patients were considered ineligible. One patient had a complete response (A+P arm) and three had a partial response (two in the LHRH+P arm and one in the A+LHRH arm). An overall log-rank test did not demonstrate any significant difference in survival among the four arms. Taking the factorial design into account, comparison of survival showed no significant difference between Anandron-containing regimens and others, or between LHRH-containing regimens and others. No serious side effects occurred for any regimen.. This controlled study shows clearly the lack of efficacy of androgen treatment in unresectable HCC. Topics: Androgen Antagonists; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Hepatocellular; Double-Blind Method; Female; Gonadotropin-Releasing Hormone; Goserelin; Humans; Imidazoles; Imidazolidines; Liver Neoplasms; Male; Survival Rate; Triptorelin Pamoate | 1998 |
[Tolerance and clinical and biological responses during the first 6 months of treatment with 1-month sustained release LHRH agonists leuprolerin and triptolerin in patients with metastatic prostate cancer].
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 | 1997 |
Stimulation of erythropoiesis by the non-steroidal anti-androgen nilutamide in men with prostate cancer: evidence for an agonistic effect?
The effects of steroid hormones are pleiotropic. Similarly, non-steroidal oestrogen receptor antagonists such as tamoxifen exert partial agonistic effects with a species- and tissue-specific pattern. Conversely, little is known of the biological effects of non-steroidal anti-androgens, whose role has been investigated in the palliative treatment of prostate cancer. We studied the effects of the non-steroidal anti-androgen nilutamide on parameters of red blood cells, an androgen-dependent cell compartment, in 24 men with prostate cancer and compared the results with those obtained in 38 historical control patients treated with D-tryptophan-6-LHRH. Administration of the anti-androgen induced a limited rise in testosterone concentrations (from 14.1 +/- 1.8 up to a maximum of 19.6 +/- 2.3 nmol l-1) and a significant increase with time in haemoglobin and haematocrit (y = 12.6 g dl-1 + 0.15 months and y = 37.3% + 0.46 months respectively, P = 0.008 for both), while no change occurred in red blood cell count (y = 4.19 x 10(6) mm-3 + 0.02 months, P = 0.2). Conversely, no variation in erythroid parameters was observed in the patients treated with the LHRH analogue (haemoglobin = 12.7 + 0.02 months, P = 0.59; haematocrit = 38.1 + 0.02 months, P = 0.9; red blood cells = 4.34 x 10(6) mm-3 + 0.15 months, P = 0.4). The difference between the linear regression slopes of haemoglobin in the two treatment groups was significant (F-ratio = 3.39, P = 0.03). While the stimulation of erythropoiesis induced by the anti-androgen might be due to incomplete neutralisation of endogenous androgens at the bone marrow level, a cell-specific agonistic effect of the drug cannot be excluded, thus calling into question the designation of pure antagonists which has been attributed to this class of compounds. Ongoing randomised trials should address this issue. Topics: Aged; Androgen Antagonists; Antineoplastic Agents; Erythrocyte Count; Erythropoiesis; Hematocrit; Hemoglobins; Humans; Imidazoles; Imidazolidines; Male; Middle Aged; Neoplasm Staging; Platelet Count; Prostatic Neoplasms; Regression Analysis; Testosterone; Triptorelin Pamoate | 1994 |
Effect of the nonsteroidal antiandrogen nilutamide on adrenal androgen secretion.
The nonsteroidal androgen-receptor antagonist nilutamide has previously been shown to inhibit adrenal androgen steroidogenesis in patients with prostatic carcinoma treated in combination with an LHRH agonist. In order to understand better the mechanisms subserving this observation, we have studied the effects of nilutamide alone on the serum concentrations of androstenedione (A), dehydroepiandrosterone (DHEA), and DHEA-sulphate (DHEA-S) in 12 patients with prostatic cancer and compared them with those achieved in 21 patients treated with the agonist D-Trp-6-LHRH. In addition, the adrenocorticotropic hormone (ACTH)-stimulated adrenal response and the thyrotropin releasing hormone (TRH)-stimulated prolactin (PRL) response observed in the patients treated with nilutamide were compared with a control group of healthy age-matched controls. No significant variation in the basal concentrations of adrenal androgens occurred either within or between both treatment groups. In response to ACTH, a decreased 17-alpha hydroxyprogesterone (17-OHP) accumulation and an augmented A/17-OHP ratio were observed in the antiandrogen group (P < 0.05 for both), suggesting the partial removal of the 17,20 lyase block which was distinctive of the untreated controls, while no significant difference was found for other steroids. Basal PRL levels were not affected by the antiandrogen, but the response to TRH was increased. We conclude that no significant inhibition of adrenal androgen secretion occurs after nilutamide or LHRH agonist treatment. Rather, administration of the antiandrogen alone may partially remove the physiological decrease in adrenal androgen secretion observed in the elderly. Topics: Adrenal Glands; Adrenocorticotropic Hormone; Aged; Androgen Antagonists; Androgens; Androstenedione; Antineoplastic Agents; Dehydroepiandrosterone; Dehydroepiandrosterone Sulfate; Humans; Imidazoles; Imidazolidines; Male; Middle Aged; Neoplasms, Hormone-Dependent; Prostatic Neoplasms; Triptorelin Pamoate | 1994 |
Other Studies
2 other study(ies) available for trelstar and nilutamide
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Long-term endocrine effects of administration of either a non-steroidal antiandrogen or a luteinizing hormone-releasing hormone agonist in men with prostate cancer.
The claimed ability of non-steroidal antiandrogens to preserve libido and sexual potency is sought as a potential improvement in the palliative management of prostate cancer. A critical issue for the clinical use of these compounds is, however, the reported evidence in the rat of an excessive increase in testosterone concentrations as a consequence of the androgen negative feedback interruption. On the other hand, the recovery of testicular function after long-term inhibition by luteinizing hormone-releasing hormone (LHRH) analogs is also an important concern in view of the proposed use of these compounds for the treatment of several non-malignant conditions. We addressed these issues by studying the long-term endocrine effects induced by the administration of either the non-steroidal antiandrogen nilutamide or the depot preparation of D-Trp6-LHRH in men with prostate cancer. Treatment with the antiandrogen induced a marked increase in gonadotropin levels, LH concentrations rising from a mean (SEM) of 17.5 +/- 1.6 to a maximum of 56.6 +/- 6.9 kU/l (p < 0.001), while mean testosterone and 17 beta estradiol-concentrations rose only by about 50% and 70% over pretreatment values, testosterone levels reaching a plateau after 1 month of treatment. In the subjects treated with the LHRH agonist, 6 months after discontinuation of long-term administration the mean (+/- SEM) LH had risen to 36.9 +/- 6.8 IU/l while mean testosterone levels were still as low as 1.7 +/- 0.7 and rose only to a maximum of 4.2 +/- 1 nmol/l after high-dose human chorionic gonadotropin loadings.(ABSTRACT TRUNCATED AT 250 WORDS) Topics: Aged; Androgen Antagonists; Endocrine Glands; Gonadotropin-Releasing Hormone; Humans; Imidazoles; Imidazolidines; Male; Middle Aged; Pituitary Hormones; Prostatic Neoplasms; Steroids; Testis; Time Factors; Triptorelin Pamoate | 1993 |
[Combined anti-androgen treatment in adenocarcinoma of the prostate: first use of a new therapeutically efficacious principle in hormone-dependent cancer].
Since the first observation reported by Huggins et al. in 1941, hormonal treatment of advanced prostatic cancer has been directed primarily at neutralizing testicular androgens by orchiectomy or estrogen therapy. These two approaches yielded a 60 to 80% positive response rate in the many studies carried out over the last forty years. However, responses were short-lived and the disease recurred rapidly in nearly every case. A possible reason for these limited results may well be related to the fact that a unique characteristic of man as compared to other species is a high level of secretion of adrenal steroids that act as precursors and are converted into androgens within the prostatic tissue itself. Complete neutralization of both testicular and adrenal androgens is therefore mandatory to achieve total suppression of the influence of androgens on the carcinoma. To accomplish this goal, we have used a combination of an LHRH agonist (or orchiectomy) and a pure antiandrogen in fifty-two previously untreated patients with prostatic carcinoma and bone metastases (stage D2). Average duration of treatment was eighteen months (six to thirty-two months). An objective positive response assessed according to the criteria set forward by the National Prostatic Cancer Project (NPCP) was recorded during the first treatment months in every case, a significant improvement over the 60 to 80% positive response rate following previous treatments confined to neutralization of testicular androgens by orchiectomy or estrogens.(ABSTRACT TRUNCATED AT 250 WORDS) Topics: Adenocarcinoma; Aged; Androgen Antagonists; Antineoplastic Agents; Drug Therapy, Combination; Flutamide; Gonadotropin-Releasing Hormone; Humans; Imidazoles; Imidazolidines; Male; Middle Aged; Neoplasms, Hormone-Dependent; Orchiectomy; Prostatic Neoplasms; Triptorelin Pamoate | 1986 |