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Androgen Deprivation Therapy and Vorinostat Followed by Radical Prostatectomy in Treating Patients With Localized Prostate Cancer (TARGET)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00589472
First Posted: January 9, 2008
Last Update Posted: October 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Cancer Institute (NCI)
Results First Submitted: March 24, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Prostate Adenocarcinoma
Stage I Prostate Cancer
Stage IIA Prostate Cancer
Stage IIB Prostate Cancer
Stage III Prostate Cancer
Interventions: Drug: Bicalutamide
Drug: Goserelin Acetate
Other: Laboratory Biomarker Analysis
Drug: Leuprolide Acetate
Procedure: Therapeutic Conventional Surgery
Drug: Vorinostat

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Treatment (Antihormone Therapy and Enzyme Inhibitor Therapy)

Patients receive bicalutamide PO QD for 1 month and leuprolide acetate IM or goserelin acetate SC once a month until surgery. Patients also receive vorinostat PO QD beginning on the first day of androgen depletion therapy and continuing for up to 8 weeks or until the day of surgery. Patients then undergo an open or laparoscopic radical prostatectomy. Patients with positive surgical margins undergo immediate adjuvant external beam radiotherapy to the prostatic fossa, based on the judgment of the treating physician.

Bicalutamide: Given PO

Goserelin Acetate: Given SC

Laboratory Biomarker Analysis: Correlative studies

Leuprolide Acetate: Given IM

Therapeutic Conventional Surgery: Undergo radical prostatectomy

Vorinostat: Given PO


Participant Flow:   Overall Study
    Treatment (Antihormone Therapy and Enzyme Inhibitor Therapy)
STARTED   19 
COMPLETED   18 
NOT COMPLETED   1 
Adverse Event                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Treatment (Antihormone Therapy and Enzyme Inhibitor Therapy)

Patients receive bicalutamide PO QD for 1 month and leuprolide acetate IM or goserelin acetate SC once a month until surgery. Patients also receive vorinostat PO QD beginning on the first day of androgen depletion therapy and continuing for up to 8 weeks or until the day of surgery. Patients then undergo an open or laparoscopic radical prostatectomy. Patients with positive surgical margins undergo immediate adjuvant external beam radiotherapy to the prostatic fossa, based on the judgment of the treating physician.

Bicalutamide: Given PO

Goserelin Acetate: Given SC

Laboratory Biomarker Analysis: Correlative studies

Leuprolide Acetate: Given IM

Therapeutic Conventional Surgery: Undergo radical prostatectomy

Vorinostat: Given PO


Baseline Measures
   Treatment (Antihormone Therapy and Enzyme Inhibitor Therapy) 
Overall Participants Analyzed 
[Units: Participants]
 19 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      14  73.7% 
>=65 years      5  26.3% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      0   0.0% 
Male      19 100.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Pathologic Complete Response at the Time of Surgery   [ Time Frame: At 12 weeks ]

2.  Secondary:   Gleason Score   [ Time Frame: Baseline ]

3.  Secondary:   Levels of DHEA in Blood From Radical Prostatectomy Specimens   [ Time Frame: Up to 1 year ]

4.  Secondary:   Levels of DHEA-S in Blood From Radical Prostatectomy Specimens   [ Time Frame: Up to 1 year ]

5.  Secondary:   Levels of DHT in Blood From Radical Prostatectomy Specimens   [ Time Frame: Up to 1 year ]

6.  Secondary:   Levels of PSA in Blood From Radical Prostatectomy Specimens   [ Time Frame: Up to 1 year ]

7.  Secondary:   Levels of Testosterone in Blood From Radical Prostatectomy Specimens   [ Time Frame: Up to 1 year ]

8.  Other Pre-specified:   Protein Expression Analysis, Including AR Target Genes, PSA and TMPRSS2   [ Time Frame: Up to 1 year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

9.  Other Pre-specified:   Safety and Tolerability of Androgen Depletion Therapy in Combination With Vorinostat as Assessed by Physical Examinations, Adverse Events, and Laboratory Assessments. Please See Adverse Events Section.   [ Time Frame: Up to 1 year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

10.  Other Pre-specified:   Gene Expression Analysis, Including AR Target Genes, PSA and TMPRSS2   [ Time Frame: at 12 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

11.  Other Pre-specified:   Gene Microarray Analysis   [ Time Frame: Up to 1 year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

12.  Other Pre-specified:   Levels of Testosterone in Prostate Tissue   [ Time Frame: Up to 1 year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

13.  Other Pre-specified:   Levels of DHT in Prostate Tissue   [ Time Frame: Up to 1 year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

14.  Other Pre-specified:   Levels of Androstenediol in Prostate Tissue   [ Time Frame: Up to 1 year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

15.  Other Pre-specified:   Levels of Androstenedione in Prostate Tissue   [ Time Frame: Up to 1 year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

16.  Other Pre-specified:   Levels of DHEA in Prostate Tissue   [ Time Frame: Up to 1 year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

17.  Other Pre-specified:   Levels of DHEA-S in Prostate Tissue   [ Time Frame: Up to 1 year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
No text entered.


  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:
unchecked 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Susan Slovin
Organization: Memorial Sloan Kettering Cancer Center
phone: 646-422-4470
e-mail: slovins@mskcc.org



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00589472     History of Changes
Other Study ID Numbers: NCI-2009-00238
NCI-2009-00238 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
06-160
MSKCC IRB 06-160
MSKCC-06160
CDR0000579559
06-160 ( Other Identifier: Memorial Sloan-Kettering Cancer Center )
7864 ( Other Identifier: CTEP )
N01CM62205 ( U.S. NIH Grant/Contract )
N01CM62206 ( U.S. NIH Grant/Contract )
P30CA008748 ( U.S. NIH Grant/Contract )
First Submitted: December 20, 2007
First Posted: January 9, 2008
Results First Submitted: March 24, 2017
Results First Posted: October 6, 2017
Last Update Posted: October 6, 2017