Mitoxantrone, Prednisone Plus Sorafenib in Taxane-Refractory Metastatic Hormone Refractory Prostate Cancer (HRPC)

This study has been terminated.

( Early stopping rule )

Study NCT00452387 Information provided by Accelerated Community Oncology Research Network

First Received on March 26, 2007. Last Updated on September 13, 2011 History of Changes

Results First Received: August 17, 2009

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Metastatic Prostate Cancer
Interventions:	Drug: Mitoxantrone Drug: Prednisone Drug: Sorafenib

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
10 community oncology research sites across the US within the ACORN network participated in this study. Enrollment started in May 2007 and was closed in July 2008 after the interim analysis was completed.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Informed consent was obtained from all subjects. All subjects underwent a screening period that could last up to 4 weeks during which pre-study assessments were completed.

Reporting Groups

	Description
Treatment Group: Mitoxantrone, Prednisone, Plus Sorafenib	The treatment plan for all subjects was mitoxantrone 12 mg/m2 IV every 21 days; sorafenib 400 mg po bid daily; and prednisone 5 mg po bid daily.

Participant Flow: Overall Study

	Treatment Group: Mitoxantrone, Prednisone, Plus Sorafenib
STARTED	22
COMPLETED	22
NOT COMPLETED	0

Baseline Characteristics

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Reporting Groups

	Description
Treatment Group: Mitoxantrone, Prednisone, Plus Sorafenib	The treatment plan for all subjects was mitoxantrone 12 mg/m2 IV every 21 days; sorafenib 400 mg po bid daily; and prednisone 5 mg po bid daily.

Baseline Measures

	Treatment Group: Mitoxantrone, Prednisone, Plus Sorafenib
Number of Participants [units: participants]	22
Age [units: participants]
<=18 years	0
Between 18 and 65 years	8
>=65 years	14
Age [units: years] Mean ± Standard Deviation	67 ± 9
Gender [units: participants]
Female	0
Male	22
Race (NIH/OMB) [units: participants]
American Indian or Alaska Native	0
Asian	0
Native Hawaiian or Other Pacific Islander	0
Black or African American	2
White	20
More than one race	0
Unknown or Not Reported	0
Region of Enrollment [units: participants]
United States	22

Outcome Measures

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1. Primary:

Median Time to Progression (TTP) by Imaging [ Time Frame: Radiologic imaging was repeated after every 4 cycles (approximately every 12 weeks) during study treatment. ]

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2. Secondary:

Correlation of Biochemical Criteria (PSA, Prostate-specific Antigen) With Objective Imaging [ Time Frame: PSA was evaluated on day 1 of every cycle (approximately every 3 weeks) during study treatment. Radiologic imaging was repeated after every 4 cycles (approximately every 12 weeks) during study treatment. ]

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3. Secondary:

Quality of Life (QoL) [ Time Frame: The Patient Care Monitor questionnaire was administered on day 1 of every cycle (approximately every 3 weeks) during study treatment. ]

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4. Secondary:

Median Overall Survival (OS) [ Time Frame: Overall survival was measured from day 1 of treatment until the end of treatment and then every 3 months thereafter until death. ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Prior to publication or presentation of Sponsored Research results, Researcher agrees to provide Bayer with such presentation or manuscript at least 30 days prior to its submission for the sole purpose of allowing Bayer to redact confidential information and protect any existing or future patents. The Principal Investigator shall acknowledge Bayer contributions where appropriate.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Early termination, according to the stopping rule included in the protocol, leading to a small number of subjects analyzed

Results Point of Contact:

Name/Title: Vice President of Scientific Affairs
Organization: Accelerated Community Oncology Research Network, Inc.
e-mail: mwalker@acorncro.com

No publications provided

Responsible Party:	Accelerated Community Oncology Research Network
ClinicalTrials.gov Identifier:	NCT00452387 History of Changes
Other Study ID Numbers:	ACORN AVAHRPC0607
Study First Received:	March 26, 2007
Results First Received:	August 17, 2009
Last Updated:	September 13, 2011
Health Authority:	United States: Institutional Review Board