Prostate CancerPhase 2NCT00002889
Radiation Therapy With Androgen Suppression in Treating Patients With Prostate Cancer
A Phase 2 study testing flutamide, goserelin and leuprolide acetate in people with Prostate Cancer, run by Alliance for Clinical Trials in Oncology at 12 sites in United States.
Trial summary
RATIONALE: Imaging procedures such as MRI may improve the ability to determine the response of prostate tumors to therapy. PURPOSE: Phase II trial to study MRI results in patients with prostate cancer that has been treated with radiation therapy plus androgen suppression therapy. Read more about this study
- Who is it for?
- Ages 30 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- flutamide, goserelin and leuprolide acetate
- Type of treatment
- Surgery or procedure
- How many people
- 180 participants
- Where
- 12 sitesUnited States
- Study dates
- May 1997to Jun 2009
- 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 30 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the prostate AJCC stage T1b-T4b, N0 or Nx, M0 Transrectal, transperineal, or transurethral biopsy required
PATIENT CHARACTERISTICS: Age: 30 and over Performance status: CALGB 0-2 Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: The following may increase the risk of protocol treatment: Serious intercurrent medical illness that might compromise patient safety Active acute infection requiring antibiotics Suppression therapy for chronic urinary tract infection allowed Uncontrolled or severe cardiovascular disease Psychiatric conditions that prevent compliance or informed consent
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for carcinoma of the prostate Endocrine therapy: No prior androgen deprivation therapy (medical or surgical) Radiotherapy: No prior radiation therapy for carcinoma of the prostate Surgery: No prior surgical androgen deprivation therapy
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Joint Center for Radiation Therapy
Boston, Massachusetts, 02215
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
Medical University of South Carolina
Charleston, South Carolina, 29425-0721
University of Chicago Cancer Research Center
Chicago, Illinois, 60637
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
St. Joseph's Hospital and Medical Center
Paterson, New Jersey, 07503
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94115-0128
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157-1082
About this study
Official title: PROGNOSTIC SIGNIFICANCE OF ENDORECTAL MRI IN PREDICTING OUTCOME AFTER COMBINED RADIATION AND ANDROGEN SUPPRESSION FOR PROSTATE CANCER: A PROSPECTIVE PHASE II STUDY
RATIONALE: Imaging procedures such as MRI may improve the ability to determine the response of prostate tumors to therapy.
PURPOSE: Phase II trial to study MRI results in patients with prostate cancer that has been treated with radiation therapy plus androgen suppression therapy.
Read the detailed description
OBJECTIVES: I. Establish whether changes between baseline and 2-month post androgen suppression endorectal coil MRI results predict for biochemical control following radiotherapy with androgen suppression in patients with adenocarcinoma of the prostate.
OUTLINE: Patients undergo a baseline endorectal coil MRI, followed by total androgen suppression (TAS) with either leuprolide IM or subcutaneous goserelin once a month plus oral flutamide 3 times a day for 2 months. Patients then receive a second endorectal coil MRI, followed by 2 months of external-beam radiotherapy plus TAS. Patients may receive an additional 2 months of TAS at the discretion of the treating physician. Patients are followed every 6 months for 3 years, then yearly thereafter.
PROJECTED ACCRUAL: Approximately 180 patients (approximately 60 per year) will be accrued for this study over a 34 months.
- Conditions
- Prostate Cancer
- Being tested
- flutamide, goserelin, leuprolide acetate, low-LET photon therapy
- Keywords
- adenocarcinoma of the prostate, stage I prostate cancer, stage II prostate cancer, stage III prostate cancer, stage IV 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.
flutamideDrug
goserelinDrug
leuprolide acetateDrug
low-LET photon therapyRadiation
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
Measured: 2 years post tx
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2004 (estimated)
- Study startMay 1997
- Primary completionJan 2004
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- 180 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
- Anthony V. D'Amico, MD, PhD, Study chair, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002889
- Sponsor's protocol ID
- CALGB-9682
- Other IDs
- U10CA031946, CLB-9682, CDR0000065212
- Status last verified
- Aug 2023
- First submitted
- 1 Nov 1999
- Last updated
- 18 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
D'Amico AV, Halabi S, Tempany C, Titelbaum D, Philips GK, Loffredo M, McMahon E, Sanford B, Vogelzang NJ, Small EJ; Cancer and Leukemia Group B. Tumor volume changes on 1.5 tesla endorectal MRI during neoadjuvant androgen suppression therapy for higher-risk prostate cancer and recurrence in men treated using radiation therapy results of the phase II CALGB 9682 study. Int J Radiat Oncol Biol Phys. 2008 May 1;71(1):9-15. doi: 10.1016/j.ijrobp.2007.09.033. Epub 2007 Nov 26.
PubMed 18037582D'Amico AV, Halabi S, Vollmer R, Loffredo M, McMahon E, Sanford B, Archer L, Vogelzang NJ, Small EJ, Kantoff PW; Cancer and Leukemia Group B. p53 protein expression status and recurrence in men treated with radiation and androgen suppression therapy for higher-risk prostate cancer: a prospective phase II Cancer and Leukemia Group B Study (CALGB 9682). Urology. 2008 May;71(5):933-7. doi: 10.1016/j.urology.2007.11.005. Epub 2008 Feb 21.
PubMed 18291508D'Amico AV, Halabi S, Tempany C, et al.: Changes on endorectal MRI during neoadjuvant hormonal therapy for prostate cancer and biochemical outcome in men managed using radiation therapy: a prospective phase II Cancer and Leukemia Group B study. [Abstract] J Clin Oncol 25 (Suppl 18): A-5072, 252s, 2007.
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROGNOSTIC SIGNIFICANCE OF ENDORECTAL MRI IN PREDICTING OUTCOME AFTER COMBINED RADIATION AND ANDROGEN SUPPRESSION FOR PROSTATE CANCER: A PROSPECTIVE PHASE II STUDY
- ClinicalTrials.gov ID
- NCT00002889
- Acronym / sponsor ID
- CALGB-9682
- Conditions
- Prostate Cancer
- Keywords
- adenocarcinoma of the prostate, stage I prostate cancer, stage II prostate cancer, stage III prostate cancer, stage IV prostate cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Alliance for Clinical Trials in OncologyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 1997
- Primary completion
- Jan 2004 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 22 Apr 2004 (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: Imaging procedures such as MRI may improve the ability to determine the response of prostate tumors to therapy.
PURPOSE: Phase II trial to study MRI results in patients with prostate cancer that has been treated with radiation therapy plus androgen suppression therapy.
Detailed description
OBJECTIVES: I. Establish whether changes between baseline and 2-month post androgen suppression endorectal coil MRI results predict for biochemical control following radiotherapy with androgen suppression in patients with adenocarcinoma of the prostate.
OUTLINE: Patients undergo a baseline endorectal coil MRI, followed by total androgen suppression (TAS) with either leuprolide IM or subcutaneous goserelin once a month plus oral flutamide 3 times a day for 2 months. Patients then receive a second endorectal coil MRI, followed by 2 months of external-beam radiotherapy plus TAS. Patients may receive an additional 2 months of TAS at the discretion of the treating physician. Patients are followed every 6 months for 3 years, then yearly thereafter.
PROJECTED ACCRUAL: Approximately 180 patients (approximately 60 per year) will be accrued for this study over a 34 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 30 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- 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 |
|---|---|---|
| flutamide | Drug | – |
| goserelin | Drug | – |
| leuprolide acetate | Drug | – |
| low-LET photon therapy | Radiation | – |
Primary outcome
Efficacy
Time frame: 2 years post tx
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 18 Aug 2023.
- Results publication: PubMed 18037582D'Amico AV, Halabi S, Tempany C, Titelbaum D, Philips GK, Loffredo M, McMahon E, Sanford B, Vogelzang NJ, Small EJ; Cancer and Leukemia Group B. Tumor volume changes on 1.5 tesla endorectal MRI during neoadjuvant androgen suppression therapy for higher-risk prostate cancer and recurrence in men treated using radiation therapy results of the phase II CALGB 9682 study. Int J Radiat Oncol Biol Phys. 2008 May 1;71(1):9-15. doi: 10.1016/j.ijrobp.2007.09.033. Epub 2007 Nov 26.
- Results publication: PubMed 18291508D'Amico AV, Halabi S, Vollmer R, Loffredo M, McMahon E, Sanford B, Archer L, Vogelzang NJ, Small EJ, Kantoff PW; Cancer and Leukemia Group B. p53 protein expression status and recurrence in men treated with radiation and androgen suppression therapy for higher-risk prostate cancer: a prospective phase II Cancer and Leukemia Group B Study (CALGB 9682). Urology. 2008 May;71(5):933-7. doi: 10.1016/j.urology.2007.11.005. Epub 2008 Feb 21.
- Results publicationD'Amico AV, Halabi S, Tempany C, et al.: Changes on endorectal MRI during neoadjuvant hormonal therapy for prostate cancer and biochemical outcome in men managed using radiation therapy: a prospective phase II Cancer and Leukemia Group B study. [Abstract] J Clin Oncol 25 (Suppl 18): A-5072, 252s, 2007.
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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.
Anthony V. D'Amico, MD, PhD study chair
Dana-Farber Cancer Institute
12 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 flutamide, goserelin and leuprolide acetate in people with Prostate Cancer, run by Alliance for Clinical Trials in Oncology at 12 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 18 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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?
Efficacy (time frame: 2 years post tx). 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 NCT00002889, which also lists 3 linked publications.
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 18 Aug 2023.