Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Antineoplastic Agents

All Drugs and Chemicals

Docetaxel

MDV3100

Use Central Contact

This study is to evaluate safety, tolerability pharmacokinetics and efficacy of MDV3100 after oral administration to patients with castration-resistant prostate cancer.

This is a Phase1/2, open-label, uncontrolled study, involving Dose-Escalation Cohorts, where dose will be escalated to next dose with the safety, tolerability, and PK being evaluated in metastatic castration-resistant prostate cancer (mCRPC) patients and an Expansion Cohort, where the efficacy, safety, and PK of MDV3100 in post-chemo mCRPC patients will be evaluated. After evaluation of the safety and tolerability in Dose-Escalation Cohorts, additional patients are included in Expansion Cohort.

A Study of MDV3100 to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy of in Prostate Cancer Patients

A Phase I/II, Open-Label, Uncontrolled, Dose-Escalation Study of MDV3100 in Patients With Castration-Resistant Prostate Cancer

Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."

This measure will be assessed on the dose escalation cohorts.

This measure will be assessed on the dose expansion cohort

This measure will be assessed on the dose expansion cohort.

Medivation LLC, a wholly owned subsidiary of Pfizer Inc.

Astellas Pharma Inc

Adenocarcinoma

Androgens

Hormones

Goserelin

Bicalutamide

Estramustine

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Hormonal

Androgen Antagonists

Hormone Antagonists

Antineoplastic Agents, Alkylating

Alkylating Agents

Given intravenously on day 2 of four three-week cycles

Taken orally three times a day for 5 days starting on day one of each three-week cycles (4 cycles)

Started 3 weeks after last chemotherapy treatment; taken orally once a day for 15 months

Casodex

Started one week after the start of casodex; zolades is given as an injection (in the stomach once every 3 months for a total of 5 injections.

Zoladex

Mary-Ellen Taplin, MD

The purpose of this study is to see if the combination of chemotherapy drugs and drugs to suppress testosterone (hormone therapy) is effective in controlling early prostate cancer.

This study will attempt to:

* stop or slow the growth of disease
* gain information about prostate cancer
* evaluate the effectiveness and side effects of the study drug

* Patients will receive two medications; docetaxel and estramustine. Estramustine will be taken orally three times daily for 5 days starting on day one. Docetaxel will be given intravenously on day 2. These two drugs will be repeated every 3 weeks for a total of 4 cycles (12 weeks).
* Patients will also take dexamethasone for three days at the beginning of each cycle to help decrease the risk of side effects.
* Patients will also take coumadin every day for three months while on the chemotherapy to reduce the risk of blood clots.
* After 12 weeks the chemotherapy phase will be completed and patient will start on the hormone therapy part of the treatment. Three weeks after the last chemotherapy treatment, patients will start Casodex orally once daily.
* After taking Casodex for 1 week, patients will then start on Zoladex (an injection in the abdomen) every 3 months for a total of 5 injections.
* During study treatment various blood tests will be performed to watch the disease. Study treatment will stop after a total of 18 months (3 months chemotherapy and 15 months hormone therapy). A physical exam and blood tests will be performed every 3 months for 2 years, every 4 months for the third year, and then every 6 months after that.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of MDV3100 to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy of in Prostate Cancer Patients	NCT01284920	Prostate Cancer Prostate Neopla... Castration Resi...	MDV3100	20 Years -	Astellas Pharma Inc
A Study of MDV3100 to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy of in Prostate Cancer Patients	NCT01284920	Prostate Cancer Prostate Neopla... Castration Resi...	MDV3100	20 Years -	Astellas Pharma Inc
Docetaxel, Estramustine and Short Term Androgen Withdrawal for Patients With a Rising PSA After Local Treatment	NCT00165399	Adenocarcinoma ... Prostate Cancer	Docetaxel Estramustine Casodex Zoladex	18 Years -	Dana-Farber Cancer Institute

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Spots Global Cancer Trial Database for psa level

Every month we try and update this database with for psa level cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for psa level cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.