Surgery in Treating Patients With Prostate Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Southwest Oncology Group
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00002938
First received: November 1, 1999
Last updated: October 16, 2013
Last verified: October 2013
  Purpose

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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • QOL assessment [ Time Frame: pre treatment; 3, 6, 12, 18, and 24 mon post treatment ] [ Designated as safety issue: No ]
    Quality of life questionnaire


Enrollment: 49
Study Start Date: May 1997
Estimated Study Completion Date: March 2016
Primary Completion Date: February 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Surgery
Salvage prostatectomy
Procedure: conventional surgery
Salvage prostatectomy

Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Ages Eligible for Study:   up to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 75 and under

Performance status:

  • CALGB (Zubrod) 0-1

Life expectancy:

  • At least 5-10 years

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • Not specified

Endocrine therapy:

  • At least 3 months since prior adjuvant hormonal therapy

Radiotherapy:

  • See Disease Characteristics
  • At least 18 months since prior external beam or interstitial radiotherapy

Surgery:

  • Not specified
  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 ClinicalTrials.gov identifier: NCT00002938

  Show 61 Study Locations
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
Southwest Oncology Group
Investigators
Study Chair: Gary D. Steinberg, MD University of Chicago
Study Chair: Joseph W. Basler, MD, PhD The University of Texas Health Science Center at San Antonio
  More Information

Additional Information:
Publications:
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
ClinicalTrials.gov Identifier: NCT00002938     History of Changes
Other Study ID Numbers: CDR0000065381, U10CA031946, CALGB-9687, SWOG-C9687
Study First Received: November 1, 1999
Last Updated: October 16, 2013
Health Authority: United States: Federal Government

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
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on September 18, 2014