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Surgery in Treating Patients With Prostate Cancer

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology Identifier:
First received: November 1, 1999
Last updated: July 1, 2016
Last verified: July 2016

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.

Condition Intervention Phase
Prostate Cancer Procedure: conventional surgery Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Role of Salvage Prostatectomy for Radiation Failure in Prostate Carcinoma: A Phase II Trial

Resource links provided by NLM:

Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • Survival characteristics [ Time Frame: pre treatment; q 3 mon for 2 years, then q 6 mon for 2 yrs, then q year ]

Secondary Outcome Measures:
  • QOL assessment [ Time Frame: pre treatment; 3, 6, 12, 18, and 24 mon post treatment ]
    Quality of life questionnaire

Enrollment: 49
Study Start Date: May 1997
Study Completion Date: January 2010
Primary Completion Date: February 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Salvage prostatectomy
Procedure: conventional surgery
Salvage prostatectomy

Detailed Description:


  • 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.


Ages Eligible for Study:   up to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00002938

  Show 61 Study Locations
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Study Chair: Gary D. Steinberg, MD University of Chicago
  More Information

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.

Responsible Party: Alliance for Clinical Trials in Oncology Identifier: NCT00002938     History of Changes
Other Study ID Numbers: CALGB-9687
U10CA031946 ( U.S. NIH Grant/Contract )
CDR0000065381 ( Registry Identifier: NCI Physician Data Query )
Study First Received: November 1, 1999
Last Updated: July 1, 2016

Keywords provided by Alliance for Clinical Trials in Oncology:
recurrent prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases processed this record on August 18, 2017