Prostate CancerPhase 2NCT00003124
Hormone Therapy Plus Radiation Therapy in Treating Patients With Prostate Cancer
A Phase 2 study testing flutamide, leuprolide acetate and radiation therapy in people with Prostate Cancer, run by Herbert Irving Comprehensive Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using leuprolide and flutamide may fight prostate cancer by reducing the production of androgens. Combining radiation therapy with hormone therapy may kill more tumor cells. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- flutamide, leuprolide acetate and radiation therapy
- Type of treatment
- Surgery or procedure
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- May 1997to Jan 2007
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically proven localized adenocarcinoma of the prostate
- Prostate specific antigen (PSA) greater than 4 or Gleason score at least 8 if PSA is no greater than 4
- CT, MRI, or pelvic lymphadenectomy negative for metastases, if PSA is no greater than 50
- Negative pelvic lymphadenectomy, if PSA is greater than 50
- Bone scan negative for metastases or PSA no greater than 20
PATIENT CHARACTERISTICS:
Age:
- Not specified
Performance Status:
- Not specified
Life Expectancy:
- Not specified
Hematopoietic:
- WBC at least 3,000/mm3
- Platelet count at least 70,000/mm3
- Hemoglobin at least 10 g/dL
- Patients on anticoagulant therapy must have a baseline PT test
Hepatic:
- Bilirubin less than 1.5 times upper limit of normal (ULN)
- ALT or AST less than 1.5 times ULN
- Alkaline phosphatase less than 1.5 times ULN
Renal:
- Creatinine less than 1.5 times ULN
Cardiovascular:
- No history of collagen vascular disease
Other:
- No acute infection requiring antibiotics
- No history of hypersensitivity to flutamide
- No history of hypersensitivity to leuprolide acetate
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Trial locations and contacts
1 site in 1 country.
United States1 site
Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
About this study
Official title: Phase II Trial of Maximal Androgen Deprivation Followed by Conformal External Beam Radiotherapy With Continued Androgen Deprivation for Clinically Localized Prostate Cancer
RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using leuprolide and flutamide may fight prostate cancer by reducing the production of androgens. Combining radiation therapy with hormone therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of hormone therapy plus radiation therapy in treating patients with prostate cancer.
Read the detailed description
OBJECTIVES:
- Assess the disease free survival of patients with localized adenocarcinoma of the prostate cancer.
- Evaluate the toxic effects of three dimensional conformal external beam radiotherapy and androgen deprivation in these patients.
OUTLINE: Patients are stratified according to PSA values and Gleason scores (class II versus class III/IV).
Patients receive intramuscular leuprolide acetate every 3 months, and oral flutamide tid.
Patients are evaluated on a monthly basis for response. Patients with unchanged or undetectable prostate specific antigen levels are considered to have reached maximal hormonal response and three dimensional conformal external beam radiotherapy is instituted. In addition, patients with disease progression are considered to have reached maximal response, and three dimensional conformal external beam radiotherapy is instituted. Radiotherapy must be administered within 6 months after initiation of leuprolide and flutamide therapy.
Hormonal therapy is administered until 9 months of treatment have elapsed.
Patients will be followed every 3 months for the first year, every 4 months for the second and third years, and every 6 months thereafter.
PROJECTED ACCRUAL: A total of 105 patients will be accrued from biologic class II over 3 years, and 58 patients from biologic class III-IV.
- Conditions
- Prostate Cancer
- Being tested
- flutamide, leuprolide acetate, radiation therapy
- Keywords
- adenocarcinoma of the prostate, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III 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
leuprolide acetateDrug
radiation therapyRadiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2003 (estimated)
- Study startMay 1997
- Study completionJan 2007
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.
- 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
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Herbert Irving Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Ronald D. Ennis, MD, Study chair, Herbert Irving Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003124
- Sponsor's protocol ID
- CDR0000065883
- Other IDs
- CPMC-IRB-7947, NCI-G97-1356
- Status last verified
- Dec 2002
- First submitted
- 1 Nov 1999
- Last updated
- 6 Jan 2014
- Results posted
- No
Publications
Heymann JJ, Benson MC, O'Toole KM, Malyszko B, Brody R, Vecchio D, Schiff PB, Mansukhani MM, Ennis RD. Phase II study of neoadjuvant androgen deprivation followed by external-beam radiotherapy with 9 months of androgen deprivation for intermediate- to high-risk localized prostate cancer. J Clin Oncol. 2007 Jan 1;25(1):77-84. doi: 10.1200/JCO.2005.05.0419.
PubMed 17194907
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Maximal Androgen Deprivation Followed by Conformal External Beam Radiotherapy With Continued Androgen Deprivation for Clinically Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT00003124
- Acronym / sponsor ID
- CDR0000065883
- Conditions
- Prostate Cancer
- Keywords
- adenocarcinoma of the prostate, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Herbert Irving Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 1997
- Study completion
- Jan 2007 (actual)
- First posted
- 18 Apr 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: Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using leuprolide and flutamide may fight prostate cancer by reducing the production of androgens. Combining radiation therapy with hormone therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of hormone therapy plus radiation therapy in treating patients with prostate cancer.
Detailed description
OBJECTIVES:
- Assess the disease free survival of patients with localized adenocarcinoma of the prostate cancer.
- Evaluate the toxic effects of three dimensional conformal external beam radiotherapy and androgen deprivation in these patients.
OUTLINE: Patients are stratified according to PSA values and Gleason scores (class II versus class III/IV).
Patients receive intramuscular leuprolide acetate every 3 months, and oral flutamide tid.
Patients are evaluated on a monthly basis for response. Patients with unchanged or undetectable prostate specific antigen levels are considered to have reached maximal hormonal response and three dimensional conformal external beam radiotherapy is instituted. In addition, patients with disease progression are considered to have reached maximal response, and three dimensional conformal external beam radiotherapy is instituted. Radiotherapy must be administered within 6 months after initiation of leuprolide and flutamide therapy.
Hormonal therapy is administered until 9 months of treatment have elapsed.
Patients will be followed every 3 months for the first year, every 4 months for the second and third years, and every 6 months thereafter.
PROJECTED ACCRUAL: A total of 105 patients will be accrued from biologic class II over 3 years, and 58 patients from biologic class III-IV.
Study design
- Primary purpose
- Treatment
Who may qualify
- 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 |
|---|---|---|
| flutamide | Drug | – |
| leuprolide acetate | Drug | – |
| radiation therapy | Radiation | – |
Primary outcome
Not reported in the source record.
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 Jan 2014.
- Results publication: PubMed 17194907Heymann JJ, Benson MC, O'Toole KM, Malyszko B, Brody R, Vecchio D, Schiff PB, Mansukhani MM, Ennis RD. Phase II study of neoadjuvant androgen deprivation followed by external-beam radiotherapy with 9 months of androgen deprivation for intermediate- to high-risk localized prostate cancer. J Clin Oncol. 2007 Jan 1;25(1):77-84. doi: 10.1200/JCO.2005.05.0419.
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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.
Ronald D. Ennis, MD study chair
Herbert Irving Comprehensive Cancer Center
1 site 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, leuprolide acetate and radiation therapy in people with Prostate Cancer, run by Herbert Irving Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00003124, 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 Jan 2014.