Prostate CancerPhase 2NCT00002938
Surgery in Treating Patients With Prostate Cancer
A Phase 2 study testing conventional surgery in people with Prostate Cancer, run by Alliance for Clinical Trials in Oncology at 61 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 75 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- conventional surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 61 sitesUnited States
- Study dates
- May 1997to Jan 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 75 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
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
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:
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
Trial locations and contacts
61 sites in 1 country.
61 sites in 1 country
United States61 sites
Northeast Alabama Regional Medical Center
Anniston, Alabama, 36207
Veterans Affairs Medical Center - Asheville
Asheville, North Carolina, 28805-9913
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, 21201
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
Vermont Cancer Center at University of Vermont
Burlington, Vermont, 05401-3498
Cancer Institute of New Jersey at the Cooper University Hospital
Camden, New Jersey, 08103
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27599-7295
Martha Jefferson Hospital
Charlottesville, Virginia, 22902
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
Louis A. Weiss Memorial Hospital
Chicago, Illinois, 60640
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, 65203
NorthEast Oncology Associates - Concord
Concord, North Carolina, 28025
Veterans Affairs Medical Center - Dallas
Dallas, Texas, 75219
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
East Syracuse, New York, 13057
Elmhurst Hospital Center
Elmhurst, New York, 11373
Cape Fear Valley Medical Center
Fayetteville, North Carolina, 28302-2000
Broward General Medical Center
Fort Lauderdale, Florida, 33316
Fort Wayne Medical Oncology and Hematology, Incorporated
Fort Wayne, Indiana, 46885-5099
CCOP - Southeast Cancer Control Consortium
Goldsboro, North Carolina, 27534-9479
Memorial Cancer Institute at Memorial Regional Hospital
Hollywood, Florida, 33021
New Hampshire Oncology-Hematology, PA - Hooksett
Hooksett, New Hampshire, 03106
St. Mary's Medical Center
Huntington, West Virginia, 25701
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, 52242-1009
Queens Cancer Center of Queens Hospital
Jamaica, New York, 11432
CCOP - Kansas City
Kansas City, Missouri, 64131
Lenoir Memorial Cancer Center
Kinston, North Carolina, 28503-1678
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, 92093-0658
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
Veterans Affairs Medical Center - Las Vegas
Las Vegas, Nevada, 89106
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756-0002
Baptist Hospital East - Louisville
Louisville, Kentucky, 40207
CCOP - North Shore University Hospital
Manhasset, New York, 11030
North Shore University Hospital
Manhasset, New York, 11030
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, 33140
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
New York Weill Cornell Cancer Center at Cornell University
New York, New York, 10021
Mount Sinai Medical Center
New York, New York, 10029
CCOP - Christiana Care Health Services
Newark, Delaware, 19713
Virginia Oncology Associates - Norfolk
Norfolk, Virginia, 23502
Oklahoma University Medical Center
Oklahoma City, Oklahoma, 73104
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Omaha, Nebraska, 68198-7680
St. Joseph's Hospital and Medical Center
Paterson, New Jersey, 07503
CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61615-7828
Comprehensive Cancer Center at Moore Regional Hospital
Pinehurst, North Carolina, 28374
Miriam Hospital at Lifespan
Providence, Rhode Island, 02906
MBCCOP - Massey Cancer Center
Richmond, Virginia, 23298-0037
West Suburban Center for Cancer Care
River Forest, Illinois, 60305
Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke
Roanoke, Virginia, 24014
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
Saint Joseph, Michigan, 49085
Naval Medical Center - San Diego
San Diego, California, 92134-3202
Veterans Affairs Medical Center - San Diego
San Diego, California, 92161
UCSF Comprehensive Cancer Center
San Francisco, California, 94115
Siteman Cancer Center at Barnes-Jewish Hospital
St Louis, Missouri, 63110
SUNY Upstate Medical University Hospital
Syracuse, New York, 13210
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5001
Veterans Affairs Medical Center - Washington, DC
Washington D.C., District of Columbia, 20422
Zimmer Cancer Center at New Hanover Regional Medical Center
Wilmington, North Carolina, 28402-9025
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, 27157-1082
UMASS Memorial Cancer Center - University Campus
Worcester, Massachusetts, 01655
About this study
Official title: 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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- conventional surgery
- Keywords
- recurrent prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional surgeryProcedure or surgery
Salvage prostatectomy
| Study group | Role | What they receive |
|---|---|---|
| Surgery | Other | Salvage prostatectomy Receives: Procedure: conventional surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival characteristics
Measured: pre treatment; q 3 mon for 2 years, then q 6 mon for 2 yrs, then q year
Secondary outcomes (1)
QOL assessment
Quality of life questionnaire
Measured: pre treatment; 3, 6, 12, 18, and 24 mon post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startMay 1997
- Primary completionFeb 2005
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Alliance for Clinical Trials in OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Gary D. Steinberg, MD, Study chair, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002938
- Sponsor's protocol ID
- CALGB-9687
- Other IDs
- U10CA031946, CALGB-9687, CDR0000065381
- Status last verified
- Jul 2016
- First submitted
- 1 Nov 1999
- Last updated
- 6 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Salvage Prostatectomy for Radiation Failure in Prostate Carcinoma: A Phase II Trial
- ClinicalTrials.gov ID
- NCT00002938
- Acronym / sponsor ID
- CALGB-9687
- Conditions
- Prostate Cancer
- Keywords
- recurrent prostate cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Alliance for Clinical Trials in OncologyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 1997
- Primary completion
- Feb 2005 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgery | Other | Procedure: conventional surgerySalvage prostatectomy |
Who may qualify
- Ages
- Up to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| conventional surgerySalvage prostatectomy | Procedure or surgery | Surgery |
Primary outcome
Survival characteristics
Time frame: pre treatment; q 3 mon for 2 years, then q 6 mon for 2 yrs, then q year
1 secondary outcome
QOL assessment
Time frame: pre treatment; 3, 6, 12, 18, and 24 mon post treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2016.
- Results publicationSokoloff 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary D. Steinberg, MD study chair
University of Chicago
61 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing conventional surgery in people with Prostate Cancer, run by Alliance for Clinical Trials in Oncology at 61 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 61 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00002938, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2016.