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The Role of Salvage Prostatectomy for Radiation Failure in Prostate Carcinoma: A Phase II Trial

Phase 2
75 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

The Role of Salvage Prostatectomy for Radiation Failure in Prostate Carcinoma: A Phase II Trial


- 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

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.

Inclusion Criteria


- 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


- Not specified


- Not specified


- Not specified


- 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


Biologic therapy:

- Not specified


- Not specified

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


- Not specified

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Survival characteristics

Outcome Time Frame:

pre treatment; q 3 mon for 2 years, then q 6 mon for 2 yrs, then q year

Safety Issue:


Principal Investigator

Gary D. Steinberg, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Chicago


United States: Federal Government

Study ID:




Start Date:

May 1997

Completion Date:

March 2016

Related Keywords:

  • Prostate Cancer
  • recurrent prostate cancer
  • Prostatic Neoplasms



Roswell Park Cancer Institute Buffalo, New York  14263
Memorial Sloan-Kettering Cancer Center New York, New York  10021
Walter Reed Army Medical Center Washington, District of Columbia  20307-5000
University of Chicago Cancer Research Center Chicago, Illinois  60637
Duke Comprehensive Cancer Center Durham, North Carolina  27710
CCOP - Kansas City Kansas City, Missouri  64131
CCOP - Southern Nevada Cancer Research Foundation Las Vegas, Nevada  89106
CCOP - Christiana Care Health Services Wilmington, Delaware  19899
CCOP - Mount Sinai Medical Center Miami Beach, Florida  33140
CCOP - North Shore University Hospital Manhasset, New York  11030
CCOP - Southeast Cancer Control Consortium Winston-Salem, North Carolina  27104-4241
MBCCOP - Massey Cancer Center Richmond, Virginia  23298-0037
CCOP - Illinois Oncology Research Association Peoria, Illinois  61602
Comprehensive Cancer Center at Wake Forest University Winston-Salem, North Carolina  27157-1082
Martha Jefferson Hospital Charlottesville, Virginia  22901
Holden Comprehensive Cancer Center at University of Iowa Iowa City, Iowa  52242-1002
UMASS Memorial Cancer Center - University Campus Worcester, Massachusetts  01605-2982
Ellis Fischel Cancer Center at University of Missouri - Columbia Columbia, Missouri  65203
Siteman Cancer Center at Barnes-Jewish Hospital Saint Louis, Missouri  63110
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center Lebanon, New Hampshire  03756-0002
Cancer Institute of New Jersey at the Cooper University Hospital Camden, New Jersey  08103-1489
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Chapel Hill, North Carolina  27599-7570
North Shore University Hospital Manhasset, New York  11030
Naval Medical Center - San Diego San Diego, California  92134-3202
Baptist Hospital East - Louisville Louisville, Kentucky  40207
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. Syracuse, New York  13217
St. Joseph's Hospital and Medical Center Paterson, New Jersey  07503
Rebecca and John Moores UCSD Cancer Center La Jolla, California  92093-0658
Broward General Medical Center Fort Lauderdale, Florida  33316
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute Boston, Massachusetts  02115
Northeast Alabama Regional Medical Center Anniston, Alabama  36207
Veterans Affairs Medical Center - San Diego San Diego, California  92161
UCSF Comprehensive Cancer Center San Francisco, California  94115
Veterans Affairs Medical Center - Washington, DC Washington, District of Columbia  20422
Louis A. Weiss Memorial Hospital Chicago, Illinois  60640
West Suburban Center for Cancer Care River Forest, Illinois  60305
Fort Wayne Medical Oncology and Hematology, Incorporated Fort Wayne, Indiana  46885-5099
Veterans Affairs Medical Center - Las Vegas Las Vegas, Nevada  89106
Elmhurst Hospital Center Elmhurst, New York  11373
Queens Cancer Center of Queens Hospital Jamaica, New York  11432
Veterans Affairs Medical Center - Asheville Asheville, North Carolina  28805
Veterans Affairs Medical Center - Dallas Dallas, Texas  75216
Virginia Oncology Associates - Norfolk Norfolk, Virginia  23502
St. Mary's Medical Center Huntington, West Virginia  25701
Oklahoma University Medical Center Oklahoma City, Oklahoma  73104
Mount Sinai Medical Center New York, New York  10029
SUNY Upstate Medical University Hospital Syracuse, New York  13210
Vermont Cancer Center at University of Vermont Burlington, Vermont  05405-0075
Greenebaum Cancer Center at University of Maryland Medical Center Baltimore, Maryland  21201
UNMC Eppley Cancer Center at the University of Nebraska Medical Center Omaha, Nebraska  68198-7680
New Hampshire Oncology-Hematology, PA - Hooksett Hooksett, New Hampshire  03106
NorthEast Oncology Associates - Concord Concord, North Carolina  28025
Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke Roanoke, Virginia  24014
Memorial Cancer Institute at Memorial Regional Hospital Hollywood, Florida  33021
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph Saint Joseph, Michigan  49085
New York Weill Cornell Cancer Center at Cornell University New York, New York  10021
Cape Fear Valley Medical Center Fayetteville, North Carolina  28302-2000
Lenoir Memorial Cancer Center Kinston, North Carolina  28503-1678
Comprehensive Cancer Center at Moore Regional Hospital Pinehurst, North Carolina  28374
Zimmer Cancer Center at New Hanover Regional Medical Center Wilmington, North Carolina  28402-9025
Miriam Hospital at Lifespan Providence, Rhode Island  02906