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NCT02560051 · ClinicalTrials.gov registry record · Phase 2

Hormone Therapy Plus Chemotherapy as Initial Treatment for Local Failures or Advanced Prostate Cancer

A Phase 2 study, sponsored by The University of Texas Health Science Center, Houston.

Terminated
Registry status
Phase 2
Development phase
19
Enrollment target

NCT02560051: Clinical Trial Phase 2 study, sponsored by The University of Texas Health Science Center, Houston.

NCT02560051 is a Phase 2 study that was terminated before completion, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 19 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02560051, a Phase 2 study, was terminated before completion, sponsored by The University of Texas Health Science Center, Houston.

TERMINATED
Registry status
Phase 2
Development phase
19 participants
Enrollment target

Study Summary

This study is for men who have prostate cancer and have failed local therapy or are not a candidate for prostatectomy or radiation therapy. The purpose of this research study is to assess the safety and benefit of androgen deprivation therapy (ADT, blocks hormones) plus chemotherapy. Degarelix is the hormone blocking drug that will be used. Doxorubicin, Ketoconazole, Docetaxel and Estramustine are the chemotherapy drugs that will be used. The drugs used in this study are approved by the Food and Drug Administration (FDA). Participants will be treated with ADT plus chemotherapy for three, four, or five 8-week cycles (12, 18, or 24 months). The number of cycles of chemotherapy they receive and the number of months they receive ADT will be based on their disease. The current standard treatment is ADT and chemotherapy. What differs in this research study is the cycling and combination of chemotherapy drugs chosen. The drugs chosen for this study have fewer side effects and are believed to provide maximum benefit.

Primary Outcome

Progression defined as increase in Prostate Specific Antigen (PSA) \>0.3 ng/mL over 2 measurements or larger/new lesion

Interventions

  • DRUG Docetaxel
  • DRUG Doxorubicin
  • DRUG Degarelix
  • DRUG Ketoconazole
  • DRUG Estramustine

Trial Details

FieldValue
Enrollment Target 19 participants
Start Date 2015-11
Est. Completion 2017-09-14
Phase Phase 2

Why NCT02560051 stopped before completion

NCT02560051 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower).

The record links to 0 conditions, and to 5 interventions - of which Docetaxel is the first listed.

NCT02560051 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02560051 about?

NCT02560051 is a clinical study titled "Hormone Therapy Plus Chemotherapy as Initial Treatment for Local Failures or Advanced Prostate Cancer". This study is for men who have prostate cancer and have failed local therapy or are not a candidate for prostatectomy or radiation therapy. The purpose of this research study is to assess the safety and benefit of androgen deprivation therapy (ADT, blocks hormones) plus chemotherapy. Degarelix is th...

What is the current status of trial NCT02560051?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 19 participants. The study started on 2015-11. Estimated completion is 2017-09-14.

What interventions are being tested in trial NCT02560051?

The interventions under investigation include: Docetaxel (DRUG), Doxorubicin (DRUG), Degarelix (DRUG), Ketoconazole (DRUG), Estramustine (DRUG).

Who is sponsoring clinical trial NCT02560051?

This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02560051's enrollment target sits among peer trials

19 1894th of 2000 higher than 103 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02560051, the US trial registry maintained by the National Library of Medicine. NCT02560051 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.