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Chemotherapy, Hormone Therapy, and Radiation Therapy in Treating Patients With Locally Advanced Prostate Cancer

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.
ClinicalTrials.gov Identifier: NCT00016913
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : January 29, 2016
Last Update Posted : July 6, 2016
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Prostate Cancer
Interventions: Drug: carboplatin
Drug: estramustine
Drug: paclitaxel
Radiation: radiation therapy
Drug: leuprolide or goserelin acetate

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Between May 15, 2001 and June 30, 2006, a total of 34 patients were enrolled in the study. All CALGB institutions, comprised of 29 major university medical centers and their affiliates, were approved to participate in this study, of which 10 CALGB sites enrolled patients.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of these 34 patients, 4 patients did not have radiotherapy, 2 patients were ineligible, and 1 case had limited follow-up data after radiotherapy. Final analyses were performed on 27 patients.

Reporting Groups
Neo-Adj ChemoTx + Ablation Prior to RT Treatment with chemotherapy plus androgen ablation prior to radiation treatment for poor prognosis localized prostate cancer

Participant Flow:   Overall Study
    Neo-Adj ChemoTx + Ablation Prior to RT

  Baseline Characteristics

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
Neo-Adj ChemoTx + Ablation Prior to RT Treatment with chemotherapy plus androgen ablation prior to radiation treatment for poor prognosis localized prostate cancer

Baseline Measures
   Neo-Adj ChemoTx + Ablation Prior to RT 
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Median (Full Range)
 (52 to 75) 
[Units: Participants]
Female   0 
Male   27 
Region of Enrollment 
[Units: Participants]
United States   27 

  Outcome Measures

1.  Primary:   Toxicity   [ Time Frame: 90 days and 1 year post treatment ]

2.  Secondary:   Time to Prostate-specific Antigen Failure   [ Time Frame: PSA was measured every 4 weeks during chemotherapy, at least every 12 weeks post radiation for 2 years, and every 6 months thereafter until PSA failure date (Up to 5.5 years). ]

3.  Secondary:   Progression-free Survival (PFS)   [ Time Frame: registration to progression, up to 5.5 years from registration ]

  Serious Adverse Events

  Other Adverse Events

  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
No text entered.

  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: Wm. Kevin Kelly, DO
Organization: Department of Medicine, Memorial Sloan-Kettering Cancer Center
e-mail: kellyw@mskcc.org

Publications of Results:

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00016913     History of Changes
Other Study ID Numbers: CALGB-99811
U10CA031946 ( U.S. NIH Grant/Contract )
CDR0000068632 ( Registry Identifier: NCI Physician Data Query )
First Submitted: June 6, 2001
First Posted: January 27, 2003
Results First Submitted: July 31, 2015
Results First Posted: January 29, 2016
Last Update Posted: July 6, 2016