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


Phase 2
N/A
75 Years
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

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:

No

Principal Investigator

Gary D. Steinberg, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Chicago

Authority:

United States: Federal Government

Study ID:

CDR0000065381

NCT ID:

NCT00002938

Start Date:

May 1997

Completion Date:

March 2016

Related Keywords:

  • Prostate Cancer
  • recurrent prostate cancer
  • Prostatic Neoplasms

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
University of Chicago Cancer Research CenterChicago, Illinois  60637
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
CCOP - North Shore University HospitalManhasset, New York  11030
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
MBCCOP - Massey Cancer CenterRichmond, Virginia  23298-0037
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Martha Jefferson HospitalCharlottesville, Virginia  22901
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
UMASS Memorial Cancer Center - University CampusWorcester, Massachusetts  01605-2982
Ellis Fischel Cancer Center at University of Missouri - ColumbiaColumbia, Missouri  65203
Siteman Cancer Center at Barnes-Jewish HospitalSaint Louis, Missouri  63110
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756-0002
Cancer Institute of New Jersey at the Cooper University HospitalCamden, New Jersey  08103-1489
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570
North Shore University HospitalManhasset, New York  11030
Naval Medical Center - San DiegoSan Diego, California  92134-3202
Baptist Hospital East - LouisvilleLouisville, Kentucky  40207
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.Syracuse, New York  13217
St. Joseph's Hospital and Medical CenterPaterson, New Jersey  07503
Rebecca and John Moores UCSD Cancer CenterLa Jolla, California  92093-0658
Broward General Medical CenterFort Lauderdale, Florida  33316
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteBoston, Massachusetts  02115
Northeast Alabama Regional Medical CenterAnniston, Alabama  36207
Veterans Affairs Medical Center - San DiegoSan Diego, California  92161
UCSF Comprehensive Cancer CenterSan Francisco, California  94115
Veterans Affairs Medical Center - Washington, DCWashington, District of Columbia  20422
Louis A. Weiss Memorial HospitalChicago, Illinois  60640
West Suburban Center for Cancer CareRiver Forest, Illinois  60305
Fort Wayne Medical Oncology and Hematology, IncorporatedFort Wayne, Indiana  46885-5099
Veterans Affairs Medical Center - Las VegasLas Vegas, Nevada  89106
Elmhurst Hospital CenterElmhurst, New York  11373
Queens Cancer Center of Queens HospitalJamaica, New York  11432
Veterans Affairs Medical Center - AshevilleAsheville, North Carolina  28805
Veterans Affairs Medical Center - DallasDallas, Texas  75216
Virginia Oncology Associates - NorfolkNorfolk, Virginia  23502
St. Mary's Medical CenterHuntington, West Virginia  25701
Oklahoma University Medical CenterOklahoma City, Oklahoma  73104
Mount Sinai Medical CenterNew York, New York  10029
SUNY Upstate Medical University HospitalSyracuse, New York  13210
Vermont Cancer Center at University of VermontBurlington, Vermont  05405-0075
Greenebaum Cancer Center at University of Maryland Medical CenterBaltimore, Maryland  21201
UNMC Eppley Cancer Center at the University of Nebraska Medical CenterOmaha, Nebraska  68198-7680
New Hampshire Oncology-Hematology, PA - HooksettHooksett, New Hampshire  03106
NorthEast Oncology Associates - ConcordConcord, North Carolina  28025
Oncology and Hematology Associates of Southwest Virginia, Incorporated - RoanokeRoanoke, Virginia  24014
Memorial Cancer Institute at Memorial Regional HospitalHollywood, Florida  33021
Lakeland Cancer Care Center at Lakeland Hospital - St. JosephSaint Joseph, Michigan  49085
New York Weill Cornell Cancer Center at Cornell UniversityNew York, New York  10021
Cape Fear Valley Medical CenterFayetteville, North Carolina  28302-2000
Lenoir Memorial Cancer CenterKinston, North Carolina  28503-1678
Comprehensive Cancer Center at Moore Regional HospitalPinehurst, North Carolina  28374
Zimmer Cancer Center at New Hanover Regional Medical CenterWilmington, North Carolina  28402-9025
Miriam Hospital at LifespanProvidence, Rhode Island  02906