Interstitial pneumonitis has been reported in 2% of patients in controlled clinical trials in patients exposed to nilutamide. A small study in Japanese subjects showed that 8 of 47 patients (17%) developed interstitial pneumonitis. Reports of interstitial changes including pulmonary fibrosis that led to hospitalization and death have been reported rarely post-marketing. Symptoms included exertional dyspnea, cough, chest pain, and fever. X-rays showed interstitial or alveolo-interstitial changes, and pulmonary function tests revealed a restrictive pattern with decreased DLco. Most cases occurred within the first 3 months of treatment with NILANDRON, and most reversed with discontinuation of therapy. A routine chest X-ray should be performed prior to initiating treatment with NILANDRON. Baseline pulmonary function tests may be considered. Patients should be instructed to report any new or worsening shortness of breath that they experience while on NILANDRON. If symptoms occur, NILANDRON should be immediately discontinued until it can be determined if the symptoms are drug related.
NILANDRON® tablets contain nilutamide, a nonsteroidal, orally active antiandrogen having the chemical name 5,5-dimethyl-3-[4-nitro-3-(trifluoromethyl)phenyl]-2,4-imidazolidinedione.
Metastatic Prostate Cancer
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.
Media Articles Related to Nilandron (Nilutamide)
Testosterone and Prostate Cancer: Looks Safe But . . . (CME/CE)
Source: MedPageToday.com - medical news plus CME for physicians [2016.09.24]
(MedPage Today) -- Data accumulating but not yet definitive
Data: May Be OK to Give 'T' to Men With Prostate Cancer
Source: Medscape Hematology-Oncology Headlines [2016.09.22]
The idea of prescribing testosterone to men with prostate cancer was once an anathema. But new data from a small patient cohort suggest that it may be okay.
Medscape Medical News
No Vasectomy-Prostate Cancer Link in Largest Study to Date
Source: Medscape Hematology-Oncology Headlines [2016.09.20]
Vasectomy is unlikely to meaningfully increase risk of developing or dying of prostate cancer, according to a new analysis of observational data.
Medscape Medical News
Vasectomy May Not Raise Prostate Cancer Risk After All
Source: MedicineNet Prostate Cancer Specialty [2016.09.20]
Title: Vasectomy May Not Raise Prostate Cancer Risk After All
Category: Health News
Created: 9/19/2016 12:00:00 AM
Last Editorial Review: 9/20/2016 12:00:00 AM
Study: Prostate Cancer-Vasectomy Link Weakens (CME/CE)
Source: MedPage Today Oncology/Hematology [2016.09.19]
(MedPage Today) -- Mortality, incidence, grade all unrelated to procedure
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. 
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. 
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)...
Clinical Trials Related to Nilandron (Nilutamide)
Genomic Guided Therapy With Dasatinib or Nilutamide in Metastatic Castration-Resistant Prostate Cancer [Terminated]
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
Vaccine Therapy Plus Sargramostim and Interleukin-2 Compared With Nilutamide Alone in Treating Patients With Prostate Cancer [Completed]
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.
Chemotherapy Plus Hormone Therapy Versus Androgen Suppression in Treating Patients With Metastatic or Unresectable Prostate Cancer [Completed]
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.
Hormone Therapy and Temsirolimus in Treating Patients With Relapsed Prostate Cancer [Terminated]
This phase I trial is studying the side effects and best dose of temsirolimus when given
together with hormone therapy in treating patients with relapsed prostate cancer. Androgens
can cause the growth of prostate cancer cells. Hormone therapy may fight prostate cancer by
lowering the amount of androgens the body makes. Temsirolimus may stop the growth of tumor
cells by blocking some of the enzymes needed for cell growth. Giving hormone therapy
together with temsirolimus may kill more tumor cells
Hormone Therapy With or Without Surgery or Radiation Therapy in Treating Patients With Prostate Cancer [Completed]
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.