Page last updated: 2024-11-01

nilutamide and Bone Cancer

nilutamide has been researched along with Bone Cancer in 9 studies

Research Excerpts

ExcerptRelevanceReference
"Nilutamide and placebo were evaluated for efficacy in 207 and 216 patients, respectively."2.67Orchiectomy and nilutamide or placebo as treatment of metastatic prostatic cancer in a multinational double-blind randomized trial. ( Abbou, CC; Bartoletti, R; Bernstein-Hahn, L; Bracken, B; Brisset, JM; Chisholm, G; Crawford, ED; Da Silva, FC; Debruyne, FM; Janknegt, RA, 1993)
"Two cases of metastatic prostate cancer demonstrating decrease in PSA of 92% and 56% on discontinuation of nilutamide therapy are reported."1.30Antiandrogen withdrawal syndrome with nilutamide. ( Gerridzen, RG; Huan, SD; Stewart, DJ; Yau, JC, 1997)

Research

Studies (9)

TimeframeStudies, this research(%)All Research%
pre-19901 (11.11)18.7374
1990's7 (77.78)18.2507
2000's1 (11.11)29.6817
2010's0 (0.00)24.3611
2020's0 (0.00)2.80

Authors

AuthorsStudies
Sartor, AO1
Tangen, CM1
Hussain, MH1
Eisenberger, MA1
Parab, M1
Fontana, JA1
Chapman, RA1
Mills, GM1
Raghavan, D1
Crawford, ED2
Labrie, F1
Dupont, A1
Belanger, A1
Cusan, L1
Lacourciere, Y1
Monfette, G1
Laberge, JG1
Emond, JP1
Fazekas, AT1
Raynaud, JP1
Husson, JM1
Janknegt, RA2
Abbou, CC2
Bartoletti, R1
Bernstein-Hahn, L1
Bracken, B1
Brisset, JM1
Da Silva, FC1
Chisholm, G1
Debruyne, FM1
Bertagna, C1
De Géry, A1
Hucher, M1
François, JP1
Zanirato, J1
Huan, SD1
Gerridzen, RG1
Yau, JC1
Stewart, DJ1
Smith, JA1
Lange, PH1
deGery, A1
Shimazaki, J1
Higa, T1
Akimoto, S1
Masai, M1
Isaka, S1
Decensi, A1
Guarneri, D1
Paoletti, MC1
Lalanne, JM1
Merlo, F1
Boccardo, F1
Béland, G1
Elhilali, M1
Fradet, Y1
Laroche, B1
Ramsey, EW1
Trachtenberg, J1
Venner, PM1
Tewari, HD1

Clinical Trials (1)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Phase II Trial of Enzalutamide in Combination With PSA-TRICOM in Patients With Non-Metastatic Castration Sensitive Prostate Cancer[NCT01875250]Phase 238 participants (Actual)Interventional2013-07-22Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Median Testosterone After 84 Days of Enzalutamide

Normal testosterone is 270-1070 nd/dL. (NCT01875250)
Timeframe: 84 days

Interventionng/dl (Median)
All Participants834

Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)

Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. (NCT01875250)
Timeframe: Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.

InterventionParticipants (Count of Participants)
Arm A - Enzalutamide for 3 Months19
Arm B - Enzalutamide for 3 Months + PSA-TRICOM19

Percent Change in Prostate Specific Antigen (PSA) After 84 Days of Enzalutamide in Course 1

Median PSA change would be considered optimal. (NCT01875250)
Timeframe: 84 days

InterventionPercent change (Median)
Arm A - Enzalutamide for 3 Months-99
Arm B - Enzalutamide for 3 Months + PSA-TRICOM-99

Tumor Growth Rate

Growth rate was measured using the growth rate equation -f(t) = exp (-d*t) + exp (g*t) -1 where exp is the base of the natural algorithm, e = 2.7182 and t is days since treatment started. The tumor growth rate equation measures Prostate Specific Antigen (PSA) rise over time. The UOM is unitless because this is a way to measure PSA kinetics. (NCT01875250)
Timeframe: 7 months

Interventionunitless (Number)
Arm A - Enzalutamide for 3 Months0.031
Arm B - Enzalutamide for 3 Months + PSA-TRICOM0.030

Mean Pretreatment Plasma Vascular Endothelial Growth Factor (VEGF) Concentration 30 Days After the Start of Course 1 and Course 2 of Enzalutamide

VEGF was measured by the enzyme-linked immunosorbent assay (ELISA) assay. The lower limit of quantitation of assay was 9.0 pg/ml. (NCT01875250)
Timeframe: 30 Days After the Start of Course 1 and Course 2 of Enzalutamide

Interventionpg/ml (Mean)
Course 1Course 2
All Participants192165.04

Median Time Until Prostate Specific Antigen (PSA) Recovery From Baseline Following Course 1 and Course 2 of Enzalutamide

PSA recovery is defined as the return above baseline PSA in participants with normal testosterone and non-metastatic, castration sensitive prostate cancer. (NCT01875250)
Timeframe: up to 41 months

InterventionDays (Median)
Course 1Course 2
All Participants224189

Reviews

1 review available for nilutamide and Bone Cancer

ArticleYear
Efficacy of the combination of nilutamide plus orchidectomy in patients with metastatic prostatic cancer. A meta-analysis of seven randomized double-blind trials (1056 patients).
    British journal of urology, 1994, Volume: 73, Issue:4

    Topics: Acid Phosphatase; Alkaline Phosphatase; Androgen Antagonists; Antineoplastic Agents; Biomarkers, Tum

1994

Trials

5 trials available for nilutamide and Bone Cancer

ArticleYear
Antiandrogen withdrawal in castrate-refractory prostate cancer: a Southwest Oncology Group trial (SWOG 9426).
    Cancer, 2008, Volume: 112, Issue:11

    Topics: Adenocarcinoma; Aged; Aged, 80 and over; Androgen Antagonists; Anilides; Bone Neoplasms; Disease-Fre

2008
Orchiectomy and nilutamide or placebo as treatment of metastatic prostatic cancer in a multinational double-blind randomized trial.
    The Journal of urology, 1993, Volume: 149, Issue:1

    Topics: Acid Phosphatase; Actuarial Analysis; Aged; Aged, 80 and over; Antineoplastic Agents; Bone Neoplasms

1993
Serum markers as a predictor of response duration and patient survival after hormonal therapy for metastatic carcinoma of the prostate.
    The Journal of urology, 1997, Volume: 157, Issue:4

    Topics: Acid Phosphatase; Alkaline Phosphatase; Androgen Antagonists; Antineoplastic Agents, Hormonal; Bone

1997
Phase II study of the pure non-steroidal antiandrogen nilutamide in prostatic cancer. Italian Prostatic Cancer Project (PONCAP).
    European journal of cancer (Oxford, England : 1990), 1991, Volume: 27, Issue:9

    Topics: Aged; Antineoplastic Agents; Bone Neoplasms; Drug Evaluation; Estradiol; Humans; Imidazoles; Imidazo

1991
A controlled trial of castration with and without nilutamide in metastatic prostatic carcinoma.
    Cancer, 1990, Sep-01, Volume: 66, Issue:5 Suppl

    Topics: Adult; Aged; Aged, 80 and over; Androgen Antagonists; Bone Neoplasms; Combined Modality Therapy; Dou

1990

Other Studies

3 other studies available for nilutamide and Bone Cancer

ArticleYear
New hormonal therapy in prostatic carcinoma: combined treatment with an LHRH agonist and an antiandrogen.
    Clinical and investigative medicine. Medecine clinique et experimentale, 1982, Volume: 5, Issue:4

    Topics: Adenocarcinoma; Androgen Antagonists; Animals; Bone Neoplasms; Buserelin; Drug Therapy, Combination;

1982
Antiandrogen withdrawal syndrome with nilutamide.
    Urology, 1997, Volume: 49, Issue:4

    Topics: Aged; Aged, 80 and over; Androgen Antagonists; Bone Neoplasms; Humans; Imidazoles; Imidazolidines; M

1997
Clinical course of bone metastasis from prostatic cancer following endocrine therapy: examination with bone x-ray.
    Advances in experimental medicine and biology, 1992, Volume: 324

    Topics: Aged; Aged, 80 and over; Bone Neoplasms; Chlormadinone Acetate; Combined Modality Therapy; Estrogens

1992