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Nilandron (Nilutamide) - Summary

 
 



NILANDRON SUMMARY

Teratogenic Effects:

NILANDRON tablets contain nilutamide, a nonsteroidal, orally active antiandrogen.

NILANDRON tablets are indicated for use in combination with surgical castration for the treatment of metastatic prostate cancer (Stage D2).

For maximum benefit, NILANDRON treatment must begin on the same day as or on the day after surgical castration.


See all Nilandron indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Nilandron (Nilutamide)

Primary Care of Prostate Cancer Survivors
Source: Medscape Family Medicine Headlines [2014.08.14]
The American Cancer Society's new guidelines outline what the primary care clinician needs to know to provide optimal care to prostate cancer patients and survivors.
Medscape Oncology

Prostate Cancer Survivors Need Well-Rounded Care
Source: Medscape Hematology-Oncology Headlines [2014.08.14]
Dr. Gerald Chodak discusses a new report from the American Cancer Society that provides guidance on long-term care for men who have been diagnosed with prostate cancer.
Medscape Urology

Physician Approaches to Prostate Cancer Vary Widely
Source: Medscape Hematology-Oncology Headlines [2014.08.12]
Dr. Gerald Chodak asks how clinicians can provide a more standardized approach to low-risk prostate cancer.
Medscape Urology

HIFU for Prostate Cancer: Efficacy Data 'Lacking'
Source: Medscape Hematology-Oncology Headlines [2014.08.11]
Dr. Gerald Chodak discusses an FDA panel's recent recommendation against approving high-intensity focused ultrasound (HIFU) for the treatment of prostate cancer.
Medscape Urology

Routine prostate cancer screening 'reduces deaths but leads to overdiagnosis'
Source: Primary Care / General Practice News From Medical News Today [2014.08.07]
Long-term results of a major European study reveal that prostate cancer screening reduces deaths by more than 20%, but researchers say it is still too soon for routine screening.

more news >>

Published Studies Related to Nilandron (Nilutamide)

Long-term efficacy and safety of nilutamide plus castration in advanced prostate cancer, and the significance of early prostate specific antigen normalization. International Anandron Study Group. [1997.07]
PURPOSE: We studied the long-term efficacy and tolerability of nilutamide, a nonsteroidal antiandrogen, combined with orchiectomy in patients with advanced prostate cancer... CONCLUSIONS: With long-term followup of patients with advanced prostate cancer, the combination of nilutamide and orchiectomy has significant benefits in interval to progression and improved survival compared to orchiectomy and placebo.

A randomised trial comparing the safety and efficacy of the Zoladex 10.8-mg depot, administered every 12 weeks, to that of the Zoladex 3.6-mg depot, administered every 4 weeks, in patients with advanced prostate cancer. The Dutch South East Cooperative Urological Group. [1995]
A new longer-acting depot formulation containing 10.8 mg Zoladex administered every 12 weeks was compared to the 3.6-mg Zoladex depot administered every 28 days, in a randomised trial in patients with advanced prostatic carcinoma in which pharmacodynamic efficacy and safety were assessed... This new formulation which is equivalent to three successive 3.6-mg depots will provide a more convenient dosing regime for both patient and doctor in this indication.

Stimulation of erythropoiesis by the non-steroidal anti-androgen nilutamide in men with prostate cancer: evidence for an agonistic effect? [1994.03]
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...

French multicentre trial comparing Casodex (ICI 176,334) monotherapy with castration plus nilutamide in metastatic prostate cancer: a preliminary report. [1994]
This trial compares Casodex (ICI 176,334) monotherapy with the combination of castration (medical or surgical) plus nilutamide. The trial is now closed to entry, 270 patients having been recruited from 32 French centres... In the majority of patients, the effects of gynaecomastia and breast tenderness did not result in withdrawal.

Total androgen blockade with the use of orchiectomy and nilutamide (Anandron) or placebo as treatment of metastatic prostate cancer. Anandron International Study Group. [1993.12.15]
The efficacy of total androgen blockade using orchiectomy and nilutamide was compared with orchiectomy with placebo in a large double-blind clinical trial with 457 patients. The median interval to objective progression was 20.8 months for total androgen blockade and 14.7 months for orchiectomy alone (P = 0.0041)...

more studies >>

Clinical Trials Related to Nilandron (Nilutamide)

Genomic Guided Therapy With Dasatinib or Nilutamide in Metastatic Castration-Resistant Prostate Cancer [Recruiting]
This is a phase II multi-center study to determine the clinical impact of using a patient-specific genomic expression signature of androgen receptor (AR) activity to determine therapy for patients with castration-resistant metastatic prostate cancer (CRPC). After patient eligibility is determined, the genomic signature will be applied to fresh frozen tissue harvested from a metastatic lesion during image-guided biopsy. After assessing for androgen receptor activity, the investigators will select patients for either continued androgen manipulation with nilutamide (high AR activity) or targeted therapy with dasatinib (low AR activity). Once patients develop a first progression on either arm, patients will receive combination therapy with dasatinib and nilutamide. The primary aim is to estimate the median progression free survival in men with CRPC treated according to tumor AR activity. The investigators hypothesize that by treating men based upon AR activity, median progression free survival (PFS) will improve from a historical median of 3. 0 months to 6. 0 months.

Vaccine Therapy Plus Sargramostim and Interleukin-2 Compared With Nilutamide Alone in Treating Patients With Prostate Cancer [Active, not recruiting]
RATIONALE: Vaccines made from prostate cancer cells may make the body build an immune response to kill tumor cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood. Interleukin-2 may stimulate a person's white blood cells to kill prostate cancer cells. Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using nilutamide may fight prostate cancer by reducing the production of androgens. It is not yet known which treatment regimen is more effective for treating prostate cancer.

PURPOSE: Randomized phase II trial to compare the effectiveness of vaccine therapy plus sargramostim and interleukin-2 with that of nilutamide alone in treating patients who have prostate cancer that has not responded to hormone therapy.

Hormone Therapy With or Without Docetaxel And Estramustine in Treating Patients With Prostate Cancer That is Locally Advanced or At High Risk of Relapse [Recruiting]
RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as nilutamide, bicalutamide, flutamide, or cyproterone may stop the adrenal glands from producing androgens. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether hormone therapy is more effective with or without chemotherapy in treating prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of hormone therapy with or without docetaxel and estramustine in treating patients who have prostate cancer that is locally advanced or at high risk of relapse.

Hormone Therapy With or Without Surgery or Radiation Therapy in Treating Patients With Prostate Cancer [Active, not recruiting]
RATIONALE: Hormones can stimulate the growth of prostate cancer cells. Hormone therapy may fight prostate cancer by reducing the production of androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether hormone therapy plus surgery is more effective than hormone therapy plus radiation therapy for prostate cancer.

PURPOSE: This randomized phase III trial is studying giving hormone therapy alone to see how well it works compared to giving hormone therapy together with bilateral orchiectomy or radiation therapy in treating patients with stage III or stage IV prostate cancer.

Chemotherapy Plus Hormone Therapy Versus Androgen Suppression in Treating Patients With Metastatic or Unresectable Prostate Cancer [Active, not recruiting]
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining hormone therapy with chemotherapy and androgen suppression may kill more tumor cells. It is not yet known which treatment regimen is more effective for prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy plus hormone therapy versus androgen suppression alone as initial therapy in patients with prostate cancer that is metastatic or that cannot be removed surgically.

more trials >>


Page last updated: 2014-08-14

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