Prostate CancerPhase 3NCT00003645
Randomized Trial of Adjuvant Hormonal Therapy in Surgically Treated Prostate Cancer Patients at High Risk for Recurrence
A Phase 3 study testing Flutamide and Leuprolide Acetate in people with Prostate Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Testosterone can stimulate the growth of prostate cancer cells. Hormone therapy using leuprolide and flutamide may fight prostate cancer by reducing the production of testosterone. It is not yet known whether receiving leuprolide and flutamide is more effective than receiving no further therapy. 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 and Leuprolide Acetate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jun 1999to 20 Mar 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Organ confined prostate cancer (stage T1-T2c) subsequent to clinical staging
- Radical prostatectomy and bilateral lymph node dissection performed
- Pathologic assessment of surgical specimens by MDACC pathologist
- High risk of clinical or biochemical failure post prostatectomy (must fulfill one of the following criteria): pathology; a) Gleason grade sum score greater than or equal to 8, b) Seminal vesicle involvement, c) Extraprostatic extension with positive surgical margins and Gleason greater than or equal to 7
- Radical prostatectomy performed within 90 days of enrollment and serum PSA level < 0.1ng/ml
- Written informed consent
Who cannot join
- Any evidence of metastatic disease confirmed prior to enrollment
- Inability to confirm pathologic risk factors or inadequate prostatectomy (see item 4.1.5).
- Hormonal ablation for greater than 3 months or radiotherapy for prostate cancer
- Failure to achieve prostate specific antigen level of less than 0.1ng/ml prior to enrollment in study
- Elevation of liver function tests 2x normal
- Contraindication to the use of LH-RH agonists or antiandrogens
- Active secondary malignancy (other than squamous or basal cell skin cancer) within five years prior to enrollment in study
- Any concomitant medical condition that would make it undesirable for the 7patient to participate in the trial or jeopardize compliance with the protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
About this study
Official title: A Phase III Randomized Prospective Trial of Adjuvant Hormonal Therapy in Surgically Treated Prostate Cancer Patients at High Risk for Recurrence
RATIONALE: Testosterone can stimulate the growth of prostate cancer cells. Hormone therapy using leuprolide and flutamide may fight prostate cancer by reducing the production of testosterone. It is not yet known whether receiving leuprolide and flutamide is more effective than receiving no further therapy.
PURPOSE: Randomized phase III trial to determine the effectiveness of hormone therapy in treating patients who have stage I or stage II prostate cancer that is at high risk of recurrence and who have already undergone surgery.
Read the detailed description
OBJECTIVES:
- Determine the effect of one year of adjuvant hormonal ablation on disease-free survival at 5 years in node-negative radical prostatectomy patients at high risk for progression.
- Determine the effect of this treatment on the incidence of androgen independent prostate cancer and on disease specific and overall survival.
- Determine the impact of one year of total androgen ablation on quality of life and serum testosterone levels.
- Assess differences in quality of life between wives of patients in the androgen ablation condition compared to wives of patients in the control condition.
- Obtain blood samples from patients at high risk for failure post-prostatectomy to evaluate serum markers of prognosis.
OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms.
- Arm I: Patients receive leuprolide intramuscularly once every 3 months and oral flutamide three times daily for 1 year.
- Arm II: Patients receive no initial treatment. Quality of life is assessed every 6 months for 5 years. Quality of life of wives/partners of patients is assessed every 6 months for two years.
Patients are followed every 3 months for 1 year and then every 6 months for 4 years.
PROJECTED ACCRUAL: A total of 496 patients (248 per treatment arm) will be accrued for this study within 3.5 years.
- Conditions
- Prostate Cancer
- Being tested
- Flutamide, Leuprolide Acetate
- Keywords
- stage I prostate cancer, stage II 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
Also called Goserelin, Zoladex
10.8 mg intramuscularly once every 3 months for 12 months
Leuprolide AcetateDrug
Also called Casodex, Bicalutamide
50 mg tablet orally daily for 12 months
| Study group | Role | What they receive |
|---|---|---|
| Arm I - Leuprolide + Flutamide | Experimental | Arm I: Patients receive leuprolide intramuscularly once every 3 months and oral flutamide three times daily for 1 year. Receives: Drug: Flutamide; Drug: Leuprolide Acetate |
| Arm II - No Treatment | No intervention | Arm II: Patients receive no initial treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Disease Free Survival at 5 Years
To determine if one year of adjuvant hormonal ablation in node negative radical prostatectomy patients at high risk for progression will result in an improvement in disease-free survival at five years.
Measured: Beginning of the study up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2003 (estimated)
- Study start14 Jun 1999
- Primary completion20 Mar 2017
- Study completion20 Mar 2017
Why it stopped: Per PI request
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Eastern Cooperative Oncology Group, AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Curtis A. Pettaway, MD, Study chair, M.D. Anderson Cancer CenterMichael O. Koch, MD, Study chair, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003645
- Sponsor's protocol ID
- ID97-077
- Other IDs
- P30CA016672, MDA-ID-97077, E-97077, NCI-T97-0069, CDR0000066733, NCI-2009-00818
- Status last verified
- Apr 2020
- First submitted
- 1 Nov 1999
- Last updated
- 28 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized Prospective Trial of Adjuvant Hormonal Therapy in Surgically Treated Prostate Cancer Patients at High Risk for Recurrence
- ClinicalTrials.gov ID
- NCT00003645
- Acronym / sponsor ID
- ID97-077
- Conditions
- Prostate Cancer
- Keywords
- stage I prostate cancer, stage II prostate cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Per PI request
- Enrolment
- 64 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Eastern Cooperative Oncology Group, AstraZeneca
- Study start
- 14 Jun 1999 (actual)
- Primary completion
- 20 Mar 2017 (actual)
- Study completion
- 20 Mar 2017 (actual)
- First posted
- 15 Jul 2003 (estimated)
- Results
- Posted 28 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Testosterone can stimulate the growth of prostate cancer cells. Hormone therapy using leuprolide and flutamide may fight prostate cancer by reducing the production of testosterone. It is not yet known whether receiving leuprolide and flutamide is more effective than receiving no further therapy.
PURPOSE: Randomized phase III trial to determine the effectiveness of hormone therapy in treating patients who have stage I or stage II prostate cancer that is at high risk of recurrence and who have already undergone surgery.
Detailed description
OBJECTIVES:
- Determine the effect of one year of adjuvant hormonal ablation on disease-free survival at 5 years in node-negative radical prostatectomy patients at high risk for progression.
- Determine the effect of this treatment on the incidence of androgen independent prostate cancer and on disease specific and overall survival.
- Determine the impact of one year of total androgen ablation on quality of life and serum testosterone levels.
- Assess differences in quality of life between wives of patients in the androgen ablation condition compared to wives of patients in the control condition.
- Obtain blood samples from patients at high risk for failure post-prostatectomy to evaluate serum markers of prognosis.
OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms.
- Arm I: Patients receive leuprolide intramuscularly once every 3 months and oral flutamide three times daily for 1 year.
- Arm II: Patients receive no initial treatment. Quality of life is assessed every 6 months for 5 years. Quality of life of wives/partners of patients is assessed every 6 months for two years.
Patients are followed every 3 months for 1 year and then every 6 months for 4 years.
PROJECTED ACCRUAL: A total of 496 patients (248 per treatment arm) will be accrued for this study within 3.5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I - Leuprolide + Flutamide | Experimental | Drug: Flutamide, Drug: Leuprolide AcetateArm I: Patients receive leuprolide intramuscularly once every 3 months and oral flutamide three times daily for 1 year. |
| Arm II - No Treatment | No intervention | –Arm II: Patients receive no initial treatment. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Organ confined prostate cancer (stage T1-T2c) subsequent to clinical staging
- Radical prostatectomy and bilateral lymph node dissection performed
- Pathologic assessment of surgical specimens by MDACC pathologist
- High risk of clinical or biochemical failure post prostatectomy (must fulfill one of the following criteria): pathology; a) Gleason grade sum score greater than or equal to 8, b) Seminal vesicle involvement, c) Extraprostatic extension with positive surgical margins and Gleason greater than or equal to 7
- Radical prostatectomy performed within 90 days of enrollment and serum PSA level < 0.1ng/ml
Key exclusion criteria (8 listed)
- Any evidence of metastatic disease confirmed prior to enrollment
- Inability to confirm pathologic risk factors or inadequate prostatectomy (see item 4.1.5).
- Hormonal ablation for greater than 3 months or radiotherapy for prostate cancer
- Failure to achieve prostate specific antigen level of less than 0.1ng/ml prior to enrollment in study
- Elevation of liver function tests 2x normal
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 |
|---|---|---|
| FlutamideAlso: Goserelin, Zoladex10.8 mg intramuscularly once every 3 months for 12 months | Drug | Arm I - Leuprolide + Flutamide |
| Leuprolide AcetateAlso: Casodex, Bicalutamide50 mg tablet orally daily for 12 months | Drug | Arm I - Leuprolide + Flutamide |
Primary outcome
Number of Participants With Disease Free Survival at 5 Years
Time frame: Beginning of the study up to 5 years
To determine if one year of adjuvant hormonal ablation in node negative radical prostatectomy patients at high risk for progression will result in an improvement in disease-free survival at five years.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Texas MD Anderson Cancer Center Official WebsiteLink provided by the sponsor.
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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.
Curtis A. Pettaway, MD study chair
M.D. Anderson Cancer Center
Michael O. Koch, MD study chair
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Flutamide and Leuprolide Acetate in people with Prostate Cancer, run by M.D. Anderson Cancer Center at 1 site 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?
The sponsor lists 6 inclusion and 8 exclusion criteria. 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: stopped early, as of the sponsor's last update on 28 Apr 2020. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Disease Free Survival at 5 Years (time frame: Beginning of the study up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Apr 2020.