Phase 2 Study of Androgen Deprivation Therapy (ADT) Plus Chemotherapy as Initial Treatment for Local Failures or Advanced Prostate Cancer

The University of Texas Health Science Center, Houston1 site in 1 country19 target enrollmentNovember 2015

ConditionsProstatic Neoplasms

InterventionsDoxorubicin Ketoconazole Docetaxel Estramustine Degarelix

DrugsDoxorubicin Ketoconazole Docetaxel Estramustine Degarelix

Overview

Phase: Phase 2
Intervention: Doxorubicin
Conditions: Prostatic Neoplasms
Sponsor: The University of Texas Health Science Center, Houston
Enrollment: 19
Locations: 1
Primary Endpoint: Efficacy as Measured by Number Who Progressed
Status: Terminated
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Detailed Description

As a working hypothesis, investigators suspect that the transformation from an androgen-dependent to an androgen-independent phenotype is mediated by expansion of an androgen-independent clone already present at the time of ADT that continues to grow while androgen-sensitive clones are being suppressed. It is thus desirable to bring treatment to bear on the androgen-independent component while the corresponding tumor burden remains minimal and prolong the time to hormone resistance. Investigators view the androgen-independent component as analogous to "microscopic residual" or "micro-metastatic" disease, for which adjuvant chemotherapy has been shown to be effective in other contexts, even when the same drugs had little or no impact on survival in the setting of more advanced disease. By treating all components of the tumor initially, investigators anticipate that the emergence of androgen-independent growth will be delayed, ultimately prolonging patient survival. Additionally, instead of treating patients empirically with an identical regimen, as in investigator's previous work, these patient subsets were designed to ensure a level of treatment appropriate to their individual disease, thus potentially lessening the burden of treatment (such as the long-term adverse effects of ADT). Investigators have chosen 3, 4, or 5 cycles of chemotherapy to be administered on the basis of tumor burden, a treatment selection method long established in germ cell tumors and used by this PI. Sub-analyses of previous data have raised the concern that treating patients with varying levels of disease the same way does not produce optimal results. Therefore, investigators seek to improve outcomes by tailoring treatment to tumor burden. In this study, patients with less tumor burden will receive 3 cycles of chemotherapy and 12 months of ADT, those with moderate tumor burden will receive 4 cycles and 18 months of treatment, and those with the greatest tumor burden will receive 5 cycles and 24 months of treatment. Additionally, this regimen of administering treatment sequentially, including a 2-week break, reduces toxicity.

Registry

clinicaltrials.gov

Start Date

November 2015

End Date

September 14, 2017

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

The University of Texas Health Science Center, Houston

Responsible Party

Principal Investigator

Robert J Amato

Director and Professor, Department of Internal Medicine, Division of Oncology

The University of Texas Health Science Center, Houston

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Intervention: Degarelix

Outcomes

Primary Outcomes

Efficacy as Measured by Number Who Progressed

Time Frame: From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 10 months

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

Secondary Outcomes

Quality of Life Measure by FACT-P Scale(about 12 weeks after completion of the last cycle)
Efficacy as Measured by Number Who PSA Progressed(From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 10 months)
Efficacy as Measured by Number of Participants With Pathology/Biopsy Positive for Disease(about 10 months after treatment initiation)
Safety of Drug Regimen as Measured by Number of Adverse Events(From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 10 months)
Efficacy as Measured by PSA Level(end of treatment, which is about about 8 weeks after the start of the last cycle)