Who is sponsoring NCT02494713?

NCT02494713 is sponsored by The University of Texas Health Science Center, Houston.

What condition does NCT02494713 study?

NCT02494713 studies Prostate Cancer.

What drugs are being tested in NCT02494713?

Interventions: Degarelix, Doxorubicin, Ketoconazole, Docetaxel, Estramustine.

What is the status of NCT02494713?

NCT02494713 is currently TERMINATED.

Last reviewed 2018-11-02 · How we verify

Neoadjuvant Androgen Deprivation Therapy and Chemotherapy Followed by Radical Prostatectomy in Patients With Prostate Cancer

NCT02494713 Phase 2 TERMINATED Results posted

This is a study for men who have locally-advanced prostate cancer and are eligible to undergo prostatectomy. Standard treatment is prostatectomy alone, but there is a chance that cancer may spread to other organs in the future, even after the prostate is removed. If this were to occur, standard treatment would be androgen deprivation therapy (ADT; hormone therapy that blocks testosterone) plus chemotherapy. Clinical trials suggest that neoadjuvant treatment (treatment given before primary therapy) may prevent a recurrence. The purpose of this research study is to assess the safety and benefit of ADT plus chemotherapy given before prostate removal.

Details

Lead sponsor	The University of Texas Health Science Center, Houston
Phase	Phase 2
Status	TERMINATED
Enrolment	4
Start date	2015-10
Completion	2017-09-14

Conditions

Prostate Cancer

Interventions

Degarelix
Doxorubicin
Ketoconazole
Docetaxel
Estramustine

Primary outcomes

Efficacy as Measured by Pathologic Response — Day of prostate removal, which is about 5 months following the day participant signed consent.
Pathologic response is defined by percentage of tumor burden remaining at time of prostate removal. Percentage of tumor burden is measured based on a pathologist's assessment of the prostate tissue removed and visual estimate of how much tumor there is in the prostate.

Countries

United States