Surgery in Treating Patients With 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. Identifier: NCT00002938
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 6, 2016
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

November 1, 1999
January 27, 2003
July 6, 2016
May 1997
February 2005   (Final data collection date for primary outcome measure)
Survival characteristics [ Time Frame: pre treatment; q 3 mon for 2 years, then q 6 mon for 2 yrs, then q year ]
Not Provided
Complete list of historical versions of study NCT00002938 on Archive Site
QOL assessment [ Time Frame: pre treatment; 3, 6, 12, 18, and 24 mon post treatment ]
Quality of life questionnaire
Not Provided
Not Provided
Not Provided
Surgery in Treating Patients With Prostate Cancer
The Role of Salvage Prostatectomy for Radiation Failure in Prostate Carcinoma: A Phase II Trial

RATIONALE: Prostatectomy may be an effective treatment for prostate cancer that has not responded to radiation therapy.

PURPOSE: This phase II trial is studying how well prostatectomy works in treating patients with recurrent or persistent prostate cancer that has not responded to radiation therapy.


  • Determine the characteristics of failure-free survival, disease-free survival, overall survival, surgical morbidity and mortality, and quality of life of patients treated with salvage prostatectomy for the recurrence of persistent disease after treatment with prior radiotherapy for localized prostate cancer.
  • Develop expertise in the use of salvage prostatectomy prior to a possible phase III trial of salvage prostatectomy in this population versus a control arm such as hormonal therapy or cryotherapy.
  • Determine the quality of life measures in these patients.
  • Determine the preliminary data on the quality of life of patients undergoing salvage radical prostatectomy and use the data to design a phase III study.
  • Determine the histologic and morphometric characterization of the carcinoma.

OUTLINE: Patients undergo modified bilateral pelvic lymph node dissection.

Patients with negative nodes undergo salvage prostatectomy via either retropubic or perineal approach. Patients with positive nodes may undergo radical prostatectomy at the discretion of the investigator.

Postoperative hormonal therapy may be given at time of symptomatic disease progression or a newly positive bone scan, or for a consistently rising prostate-specific antigen. Adjuvant hormonal therapy is also allowed.

Quality of life is assessed prior to surgery and at 3, 6, 12, 18, and 24 months after surgery.

Patients are followed at least every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 2 years.

Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Prostate Cancer
Procedure: conventional surgery
Salvage prostatectomy
Salvage prostatectomy
Intervention: Procedure: conventional surgery
Sokoloff MH, Halabi S, Sanford B, et al.: Management of recurrent prostate cancer after radiotherapy: preliminary results of CALGB 9687, a contemporary salvage prostatectomy series. [Abstract] American Society of Clinical Oncology 2005 Prostate Cancer Symposium, 17-19 February 2005, Orlando, Florida. A-166, 2005.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Not Provided
January 2010
February 2005   (Final data collection date for primary outcome measure)


  • Histologically proven recurrent or persistent prostate cancer
  • Prostate-specific antigen (PSA) no greater than 20 ng/mL
  • Must have been previously treated with at least 60 cGy of external beam radiotherapy or brachytherapy for clinical stages T1-2NXM0 with PSA no greater than 30 ng/mL
  • No metastatic disease at time of biopsy



  • 75 and under

Performance status:

  • CALGB (Zubrod) 0-1

Life expectancy:

  • At least 5-10 years


  • No other "currently Temporarily closed" malignancy except nonmelanoma skin cancer

    • Patients are not considered to have a "currently Temporarily closed" malignancy if they have completed therapy and are considered to be at less than 30% risk of relapse


Endocrine therapy:

  • At least 3 months since prior adjuvant hormonal therapy


  • See Disease Characteristics
  • At least 18 months since prior external beam or interstitial radiotherapy
Sexes Eligible for Study: Male
up to 75 Years   (Child, Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
U10CA031946 ( U.S. NIH Grant/Contract )
CDR0000065381 ( Registry Identifier: NCI Physician Data Query )
Not Provided
Not Provided
Alliance for Clinical Trials in Oncology
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Study Chair: Gary D. Steinberg, MD University of Chicago
Alliance for Clinical Trials in Oncology
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP