CancerPhase 2TAPSNCT00298155
Maximal Suppression of the Androgen Axis in Clinically Localized Prostate Cancer
A Phase 2 study testing goserelin with dutasteride, goserelin with bicalutamide and dutasteride and goserelin with bicalutamide and dutasteride and ketoconazole in people with Cancer and Prostate Neoplasms, run by University of Washington at 2 sites in United States.
Trial summary
Prostate cancer (CaP) is the most commonly diagnosed cancer among males in the U.S. and the second leading cause of cancer-related mortality. More than 230,000 men will be diagnosed with prostate cancer in the USA this year and more than 30,000 will die of this disease. Read more about this study
- Who is it for?
- Ages 18 to 100 years, men only
- Conditions the study is for
- Cancer, Prostate Neoplasms
- What is being tested?
- goserelin with dutasteride, goserelin with bicalutamide and dutasteride and goserelin with bicalutamide and dutasteride and ketoconazole
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2006to Jan 2014
- Phase
- Phase 2
- 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 18 to 100 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men 18 years or older with a histologic diagnosis of clinically localized prostate cancer prior to radical prostatectomy as defined by:
- Clinical stage T1-T2b
- Prostate specific Antigen (PSA) less than 20
- Gleason score 7-10
- Patient's tumor must be considered surgically resectable .
- Eastern Cooperative Group (ECOG) performance status of 0-1.
Show all 9Show fewer
- Life expectancy greater than 2 years.
- Able to understand and give informed consent.
- Laboratory values must be within specified limits.
Who cannot join
- Patients with locally advanced or high risk disease not meeting the criteria defined above.
- Patients who have a total testosterone less than 280 ng/dL.
- Patients who are receiving any other investigational therapy.
- Patients with an active serious infection or other serious underlying medical condition.
- Dementia or significantly altered mental status that would prohibit the understanding and/or giving of informed consent.
- Histologic evidence of small cell carcinoma of the prostate.
Show all 15Show fewer
- Patients who are currently receiving active therapy for other neoplastic disorders.
- Patients who are receiving any androgens, estrogens or progestational agents.
- Patients who are taking drugs or herbal supplements which affect androgen metabolism (e.g., spironolactone, aprepitant, bexarotene, clarithromycin, itraconazole, ketoconazole, St. John's wort).
- Patients who have chronic active hepatitis.
- Patients taking any of the following medications who cannot discontinue these medications for three months during administration of ketoconazole; statin cholesterol medications, cyclosporine, isoniazid, rifampin, terfenadine, triazolam or astemizole.
- Patients who have history of cerebrovascular accident, deep venous thrombosis, pulmonary emboli, unstable angina or clinical congestive heart failure.
- Medical conditions, which, in the opinion of the investigators would jeopardize either the patient or the integrity of the data obtained.
- Patients unwilling to use contraceptives while on study.
- Patients with a risk of nodal involvement of greater than 10% should have received a bone scan and CT of the pelvis prior to screening for the study as part of standard of care.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Veterans' Administration Puget Sound Health Care System (VAPSHCS)
Seattle, Washington, 98108-1532
University of Washington
Seattle, Washington, 98195-6158
About this study
Prostate cancer (CaP) is the most commonly diagnosed cancer among males in the U.S. and the second leading cause of cancer-related mortality. More than 230,000 men will be diagnosed with prostate cancer in the USA this year and more than 30,000 will die of this disease.
Androgen deprivation, the elimination of testosterone and its active metabolites, remains the single most effective intervention available for the treatment of advanced prostate carcinoma. This is usually achieved by surgical removal of the testes (orchiectomy), by suppressing production of testosterone (LHRH agonists) and/or by blocking the androgens at receptor sites (antiandrogens). Unfortunately, androgen suppression does not cure the disease. Most patients progress within 0-5 years, and all patients ultimately progress if the cancer is not eliminated during initial therapy (usually prostatectomy or radiation).
Read more
Hormone suppression treatment eliminates the detectable levels of testosterone in the blood. However, the testosterone levels in tissue remain high enough to stimulate androgen receptors. Overexpression of androgen receptors is present in all cell lines which demonstrate "androgen independence," i.e., are resistant to androgen-suppressive therapy.
Approximately 95% of testosterone is supplied by the testes, with the remaining 5% supplied by the adrenal glands. The presumption that standard androgen deprivation achieves the optimal level of androgen suppression for patients is based on the levels of androgen which result from orchiectomy. However, because adrenal androgen levels are unaffected by standard modes of androgen deprivation, 5% of the body's testosterone remains despite hormone therapy.
The hypothesis of this study is that more effective suppression of the androgen axis through elimination of adrenal androgens and more effective suppression of testosterone metabolites will lower intraprostatic androgen levels, minimizing activation of the androgen receptor and augmenting natural cell death (apoptosis). The investigators propose to test this hypothesis by administering neoadjuvant (pre-surgery) androgen deprivation therapy of different types before prostatectomy for patients with clinically localized prostate cancer. The investigators will assay serum and intraprostatic androgen levels, while assessing relative levels of apoptosis of normal and malignant tissue.
Read the detailed description
Androgen deprivation has been the principal means of controlling advanced prostate cancer, but does not cure the disease and all patients ultimately progress if the tumor is not eliminated with definitive local therapy. It has been demonstrated that despite androgen deprivation with LHRH agonists or orchiectomy, prostate tissue and prostate cancer maintain levels of androgens which are more than adequate to stimulate the androgen receptor. These levels of androgen may continue to stimulate the receptor and allow both survival of tumor cells and induction of resistance by overexpression of the receptor. The presumption that standard androgen deprivation achieves the optimal level of androgen suppression for patients is based on the levels of androgen achieved with castration, which achieves relatively short term control of cancer in the majority of patients. The hypothesis of this study is that more effective suppression of the androgen axis through elimination of adrenal androgens and more effective suppression of conversion to dihydrotestosterone will lower intraprostatic androgen levels, minimizing activation of the androgen receptor and augmenting apoptosis. We propose to test this hypothesis in a prospective, randomized trial, administering neoadjuvant androgen deprivation therapy of different types prior to radical prostatectomy for patients with clinically localized prostate cancer for 3 months.
Plan of therapy
Patients with clinically localized (cT1-T2) prostate cancer, at intermediate-high risk for relapse who are candidates for radical prostatectomy will be treated with one of three regimens:
- Goserelin with dutasteride
- Goserelin with bicalutamide and dutasteride
- Goserelin with bicalutamide and dutasteride and ketoconazole
Patients will undergo radical prostatectomy 3 months after initiation of treatment.
Preoperative and intraoperative biopsies of the prostate gland will be utilized for analysis of prostatic hormones, gene expression and apoptosis.
- Conditions
- Cancer, Prostate Neoplasms
- Being tested
- goserelin with dutasteride, goserelin with bicalutamide and dutasteride, goserelin with bicalutamide and dutasteride and ketoconazole
- Medical subject headings
- Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
goserelin with dutasterideDrug
Bicalutamide 50 mg qd for one week, inject goserelin 10.8 mg (3-month depot) and begin dutasteride 3.5 mg qd; continue bicalutamide for one more week.
goserelin with bicalutamide and dutasterideDrug
Bicalutamide 50 mg qd for one week, inject goserelin 10.8 mg (3-month depot) and begin dutasteride 3.5 mg qd.
goserelin with bicalutamide and dutasteride and ketoconazoleDrug
Bicalutamide 50 mg qd for one week, inject goserelin 10.8 mg (3-month depot), begin dutasteride 3.5 mg qd and ketoconazole 200 mg tid (with hydrocortisone 30 mg).
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Goserelin + dutasteride Receives: Drug: goserelin with dutasteride |
| Group 2 | Active comparator | Bicalutamide for one week, begin goserelin plus dutasteride, continue bicalutamide for the full 12 weeks Receives: Drug: goserelin with bicalutamide and dutasteride |
| Group 3 | Active comparator | Begin bicalutamide for one week, goserelin injection; begin dutasteride, ketoconazole (and replacement hydrocortisone), continue bicalutamide for the full 12 weeks Receives: Drug: goserelin with bicalutamide and dutasteride and ketoconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prostate Tissue DHT
Tissue dihydrotesterone (DHT)
Measured: After 12 weeks of neoadjuvant androgen deprivation
Secondary outcomes (1)
To Determine the Effects of Different Modes of Androgen Deprivation on Serum DHT
Serum DHT
Measured: After 12 weeks of neoadjuvant androgen deprivation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2006 (estimated)
- Study startJul 2006
- Primary completionJun 2010
- Study completionJan 2014
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.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline, AstraZeneca
- Responsible party
- Principal investigator, Bruce Montgomery, University of Washington
- Investigators
- R. Bruce Montgomery, MD, Principal investigator, University of Washington; Seattle Cancer Care Alliance; VA Puget Sound HCSPeter S. Nelson, MD, Principal investigator, Fred Hutchinson Cancer Research Center; Seattle Cancer Care Alliance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00298155
- Sponsor's protocol ID
- 28741
- Other IDs
- FHCRC-05026, 05-8538-V 01, 28741-A, 01253
- Acronym
- TAPS
- Status last verified
- Jul 2018
- First submitted
- 27 Feb 2006
- Last updated
- 9 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Mostaghel EA, Nelson PS, Lange P, Lin DW, Taplin ME, Balk S, Ellis W, Kantoff P, Marck B, Tamae D, Matsumoto AM, True LD, Vessella R, Penning T, Hunter Merrill R, Gulati R, Montgomery B. Targeted androgen pathway suppression in localized prostate cancer: a pilot study. J Clin Oncol. 2014 Jan 20;32(3):229-37. doi: 10.1200/JCO.2012.48.6431. Epub 2013 Dec 9.
PubMed 24323034Tamae D, Byrns M, Marck B, Mostaghel EA, Nelson PS, Lange P, Lin D, Taplin ME, Balk S, Ellis W, True L, Vessella R, Montgomery B, Blair IA, Penning TM. Development, validation and application of a stable isotope dilution liquid chromatography electrospray ionization/selected reaction monitoring/mass spectrometry (SID-LC/ESI/SRM/MS) method for quantification of keto-androgens in human serum. J Steroid Biochem Mol Biol. 2013 Nov;138:281-9. doi: 10.1016/j.jsbmb.2013.06.014. Epub 2013 Jul 10.
PubMed 23851165Dean JP, Sprenger CC, Wan J, Haugk K, Ellis WJ, Lin DW, Corman JM, Dalkin BL, Mostaghel E, Nelson PS, Cohen P, Montgomery B, Plymate SR. Response of the insulin-like growth factor (IGF) system to IGF-IR inhibition and androgen deprivation in a neoadjuvant prostate cancer trial: effects of obesity and androgen deprivation. J Clin Endocrinol Metab. 2013 May;98(5):E820-8. doi: 10.1210/jc.2012-3856. Epub 2013 Mar 26.
PubMed 23533230
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maximal Suppression of the Androgen Axis in Clinically Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT00298155
- Acronym / sponsor ID
- TAPS / 28741
- Conditions
- Cancer, Prostate Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- GlaxoSmithKline, AstraZeneca
- Study start
- Jul 2006
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 1 Mar 2006 (estimated)
- Results
- Posted 8 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prostate cancer (CaP) is the most commonly diagnosed cancer among males in the U.S. and the second leading cause of cancer-related mortality. More than 230,000 men will be diagnosed with prostate cancer in the USA this year and more than 30,000 will die of this disease.
Androgen deprivation, the elimination of testosterone and its active metabolites, remains the single most effective intervention available for the treatment of advanced prostate carcinoma. This is usually achieved by surgical removal of the testes (orchiectomy), by suppressing production of testosterone (LHRH agonists) and/or by blocking the androgens at receptor sites (antiandrogens). Unfortunately, androgen suppression does not cure the disease. Most patients progress within 0-5 years, and all patients ultimately progress if the cancer is not eliminated during initial therapy (usually prostatectomy or radiation).
Hormone suppression treatment eliminates the detectable levels of testosterone in the blood. However, the testosterone levels in tissue remain high enough to stimulate androgen receptors. Overexpression of androgen receptors is present in all cell lines which demonstrate "androgen independence," i.e., are resistant to androgen-suppressive therapy.
Approximately 95% of testosterone is supplied by the testes, with the remaining 5% supplied by the adrenal glands. The presumption that standard androgen deprivation achieves the optimal level of androgen suppression for patients is based on the levels of androgen which result from orchiectomy. However, because adrenal androgen levels are unaffected by standard modes of androgen deprivation, 5% of the body's testosterone remains despite hormone therapy.
The hypothesis of this study is that more effective suppression of the androgen axis through elimination of adrenal androgens and more effective suppression of testosterone metabolites will lower intraprostatic androgen levels, minimizing activation of the androgen receptor and augmenting natural cell death (apoptosis). The investigators propose to test this hypothesis by administering neoadjuvant (pre-surgery) androgen deprivation therapy of different types before prostatectomy for patients with clinically localized prostate cancer. The investigators will assay serum and intraprostatic androgen levels, while assessing relative levels of apoptosis of normal and malignant tissue.
Detailed description
Androgen deprivation has been the principal means of controlling advanced prostate cancer, but does not cure the disease and all patients ultimately progress if the tumor is not eliminated with definitive local therapy. It has been demonstrated that despite androgen deprivation with LHRH agonists or orchiectomy, prostate tissue and prostate cancer maintain levels of androgens which are more than adequate to stimulate the androgen receptor. These levels of androgen may continue to stimulate the receptor and allow both survival of tumor cells and induction of resistance by overexpression of the receptor. The presumption that standard androgen deprivation achieves the optimal level of androgen suppression for patients is based on the levels of androgen achieved with castration, which achieves relatively short term control of cancer in the majority of patients. The hypothesis of this study is that more effective suppression of the androgen axis through elimination of adrenal androgens and more effective suppression of conversion to dihydrotestosterone will lower intraprostatic androgen levels, minimizing activation of the androgen receptor and augmenting apoptosis. We propose to test this hypothesis in a prospective, randomized trial, administering neoadjuvant androgen deprivation therapy of different types prior to radical prostatectomy for patients with clinically localized prostate cancer for 3 months.
Plan of therapy
Patients with clinically localized (cT1-T2) prostate cancer, at intermediate-high risk for relapse who are candidates for radical prostatectomy will be treated with one of three regimens:
- Goserelin with dutasteride
- Goserelin with bicalutamide and dutasteride
- Goserelin with bicalutamide and dutasteride and ketoconazole
Patients will undergo radical prostatectomy 3 months after initiation of treatment.
Preoperative and intraoperative biopsies of the prostate gland will be utilized for analysis of prostatic hormones, gene expression and apoptosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: goserelin with dutasterideGoserelin + dutasteride |
| Group 2 | Active comparator | Drug: goserelin with bicalutamide and dutasterideBicalutamide for one week, begin goserelin plus dutasteride, continue bicalutamide for the full 12 weeks |
| Group 3 | Active comparator | Drug: goserelin with bicalutamide and dutasteride and ketoconazoleBegin bicalutamide for one week, goserelin injection; begin dutasteride, ketoconazole (and replacement hydrocortisone), continue bicalutamide for the full 12 weeks |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Men 18 years or older with a histologic diagnosis of clinically localized prostate cancer prior to radical prostatectomy as defined by:
- Patient's tumor must be considered surgically resectable .
- Eastern Cooperative Group (ECOG) performance status of 0-1.
- Life expectancy greater than 2 years.
- Able to understand and give informed consent.
Key exclusion criteria (15 listed)
- Patients with locally advanced or high risk disease not meeting the criteria defined above.
- Patients who have a total testosterone less than 280 ng/dL.
- Patients who are receiving any other investigational therapy.
- Patients with an active serious infection or other serious underlying medical condition.
- Dementia or significantly altered mental status that would prohibit the understanding and/or giving of informed consent.
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 |
|---|---|---|
| goserelin with dutasterideBicalutamide 50 mg qd for one week, inject goserelin 10.8 mg (3-month depot) and begin dutasteride 3.5 mg qd; continue bicalutamide for one more week. | Drug | Group 1 |
| goserelin with bicalutamide and dutasterideBicalutamide 50 mg qd for one week, inject goserelin 10.8 mg (3-month depot) and begin dutasteride 3.5 mg qd. | Drug | Group 2 |
| goserelin with bicalutamide and dutasteride and ketoconazoleBicalutamide 50 mg qd for one week, inject goserelin 10.8 mg (3-month depot), begin dutasteride 3.5 mg qd and ketoconazole 200 mg tid (with hydrocortisone 30 mg). | Drug | Group 3 |
Primary outcome
Prostate Tissue DHT
Time frame: After 12 weeks of neoadjuvant androgen deprivation
Tissue dihydrotesterone (DHT)
1 secondary outcome
To Determine the Effects of Different Modes of Androgen Deprivation on Serum DHT
Time frame: After 12 weeks of neoadjuvant androgen deprivation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24323034Mostaghel EA, Nelson PS, Lange P, Lin DW, Taplin ME, Balk S, Ellis W, Kantoff P, Marck B, Tamae D, Matsumoto AM, True LD, Vessella R, Penning T, Hunter Merrill R, Gulati R, Montgomery B. Targeted androgen pathway suppression in localized prostate cancer: a pilot study. J Clin Oncol. 2014 Jan 20;32(3):229-37. doi: 10.1200/JCO.2012.48.6431. Epub 2013 Dec 9.
- Derived from this study: PubMed 23851165Tamae D, Byrns M, Marck B, Mostaghel EA, Nelson PS, Lange P, Lin D, Taplin ME, Balk S, Ellis W, True L, Vessella R, Montgomery B, Blair IA, Penning TM. Development, validation and application of a stable isotope dilution liquid chromatography electrospray ionization/selected reaction monitoring/mass spectrometry (SID-LC/ESI/SRM/MS) method for quantification of keto-androgens in human serum. J Steroid Biochem Mol Biol. 2013 Nov;138:281-9. doi: 10.1016/j.jsbmb.2013.06.014. Epub 2013 Jul 10.
- Derived from this study: PubMed 23533230Dean JP, Sprenger CC, Wan J, Haugk K, Ellis WJ, Lin DW, Corman JM, Dalkin BL, Mostaghel E, Nelson PS, Cohen P, Montgomery B, Plymate SR. Response of the insulin-like growth factor (IGF) system to IGF-IR inhibition and androgen deprivation in a neoadjuvant prostate cancer trial: effects of obesity and androgen deprivation. J Clin Endocrinol Metab. 2013 May;98(5):E820-8. doi: 10.1210/jc.2012-3856. Epub 2013 Mar 26.
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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.
R. Bruce Montgomery, MD principal investigator
University of Washington; Seattle Cancer Care Alliance; VA Puget Sound HCS
Peter S. Nelson, MD principal investigator
Fred Hutchinson Cancer Research Center; Seattle Cancer Care Alliance
2 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 goserelin with dutasteride, goserelin with bicalutamide and dutasteride and goserelin with bicalutamide and dutasteride and ketoconazole in people with Cancer and Prostate Neoplasms, run by University of Washington at 2 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?
The sponsor lists 9 inclusion and 15 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: finished, as of the sponsor's last update on 9 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Yes. Results are posted in the registry (first posted 8 May 2017). 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?
Prostate Tissue DHT (time frame: After 12 weeks of neoadjuvant androgen deprivation). 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 NCT00298155, 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 9 Aug 2018; AzTrials last refreshed its copy on 6 Nov 2026.