MDX-010 for Advanced Prostate Cancer

12:47 EDT 21st October 2014 | BioPortfolio

Summary

A total of 108 males with advanced prostate cancer will be enrolled into this study. Patients must have undergone prostate cancer staging within 180 days of enrollment. 54 patients will be randomized to receive hormone therapy alone and 54 patients will be randomized to receive hormone therapy plus the MDX-010 therapy.

Description

This trial has been designed to ensure the capture of both treatment mechanism-specific data as well as clinically meaningful data within a relatively compressed study interval. Thus, this trial is constructed around a single inductive short-term cycle of AA therapy.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Prostatic Neoplasms

Intervention

Combination Androgen Ablative Therapy, MDX-010 therapy

Location

Mayo Clinic
Rochester
Minnesota
United States
55905

Status

Active, not recruiting

Source

Mayo Clinic

Results (where available)

View Results

Links

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Prevention of Osteoporosis in Men With Prostate Cancer on Androgen Deprivation Therapy (POP Study)

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Phase I/II Dose Escalation Study of VELCADE® and Docetaxel in Patients With Advanced Androgen-Independent Prostate Cancer

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PubMed Articles [13764 Associated PubMed Articles listed on BioPortfolio]

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Upregulation of androgen-responsive genes and transforming growth factor-β1 cascade genes in a rat model of non-bacterial prostatic inflammation.

Prostatic inflammation is associated with the development of prostatic hyperplasia. We investigated the effects of prostatic inflammation on expression levels of androgen-responsive genes and growth f...

Androgens and prostate disease.

A growing body of literature has established the anabolic benefi ts of testosterone (T) therapy in hypogonadal men. However, there remains a paucity of data regarding the risks of exogenous androgen u...

Androgen deprivation therapy in castrate-resistant prostate cancer: how important is GnRH agonist backbone therapy?

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Medical and Biotech [MESH] Definitions

Therapy with two or more separate preparations given for a combined effect.

An anti-androgen that, in the form of its acetate (CYPROTERONE ACETATE), also has progestational properties. It is used in the treatment of hypersexuality in males, as a palliative in prostatic carcinoma, and, in combination with estrogen, for the therapy of severe acne and hirsutism in females.

Preliminary cancer therapy (chemotherapy, radiation therapy, hormone/endocrine therapy, immunotherapy, hyperthermia, etc.) that precedes a necessary second modality of treatment.

A synthetic non-aromatizable androgen and anabolic steroid. It binds strongly to the androgen receptor and has therefore also been used as an affinity label for this receptor in the prostate and in prostatic tumors.

A therapeutic approach, involving chemotherapy, radiation therapy, or surgery, after initial regimens have failed to lead to improvement in a patient's condition. Salvage therapy is most often used for neoplastic diseases.

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