Primary outcomeMean· After 12 weeks of neoadjuvant androgen deprivation
Prostate Tissue DHT
| Group | Value (ng/g) | Spread |
|---|---|---|
| Group 1 | 0.03 | 0.01 |
| Group 2 | 0.06 | 0.06 |
| Group 3 | 0.03 | 0.02 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataMaximal Suppression of the Androgen Axis in Clinically Localized Prostate Cancer
Short name TAPS
NCTNCT00298155 (opens ClinicalTrials.gov in a new tab)Other id28741Other idFHCRC-05026Other id05-8538-V 01Other id28741-A
Overview
- Status
- Completed
- Phase
- Phase 2
- Enrollment
- 35 participants (actual)
- Sponsor
- University of Washington · Other
- Design
- Randomized · Open label (no masking)
- Countries
1 country
United States
- Start
- Jul 2006
- Primary completion
- Jun 2010
- Completion
- Jan 2014
- First posted
- 1 Mar 2006 (estimated)
- Last update posted
- 9 Aug 2018
- Conditions
- Cancer · Prostate Neoplasms
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
20062008201020122014
- Ph 2
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- goserelin with dutasterideDrug
- goserelin with bicalutamide and dutasterideDrug
- goserelin with bicalutamide and dutasteride and ketoconazoleDrug
Arms3
Active comparator
Group 1
Goserelin + dutasteride
Active comparator
Group 2
Bicalutamide for one week, begin goserelin plus dutasteride, continue bicalutamide for the full 12 weeks
Active comparator
Group 3
Begin bicalutamide for one week, goserelin injection; begin dutasteride, ketoconazole (and replacement hydrocortisone), continue bicalutamide for the full 12 weeks
Primary outcomes1
Outcomes the sponsor listed as primary.
Prostate Tissue DHT
Time frame · After 12 weeks of neoadjuvant androgen deprivation
Registry description
Tissue dihydrotesterone (DHT)
Secondary outcomes(1)
To Determine the Effects of Different Modes of Androgen Deprivation on Serum DHT
Time frame · After 12 weeks of neoadjuvant androgen deprivation
Registry description
Serum DHT
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(1)
Secondary outcomeMean· After 12 weeks of neoadjuvant androgen deprivation
To Determine the Effects of Different Modes of Androgen Deprivation on Serum DHT
| Group | Value (ng/dL) | Spread |
|---|---|---|
| Group 1 | 4.2 | 3.4 |
| Group 2 | 3.6 | 2.0 |
| Group 3 | 5.7 | 4.9 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Group 1Goserelin + dutasteride goserelin with dutasteride: 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. | – | 0 / 12 | 12 / 12 |
| Group 2Bicalutamide for one week, begin goserelin plus dutasteride, continue bicalutamide for the full 12 weeks goserelin with bicalutamide and dutasteride: Bicalutamide 50 mg qd for one week, inject goserelin 10.8 mg (3-month depot) and begin dutasteride 3.5 mg qd. | – | 0 / 10 | 10 / 10 |
| Group 3Begin bicalutamide for one week, goserelin injection; begin dutasteride, ketoconazole (and replacement hydrocortisone), continue bicalutamide for the full 12 weeks goserelin with bicalutamide and dutasteride and ketoconazole: 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). | – | 0 / 13 | 13 / 13 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies2
Studies that cite this trial.
More studies
2 studies on this page
Indexing hint: Randomized controlled trial · 2014
Targeted androgen pathway suppression in localized prostate cancer: a pilot study.
Mostaghel et al. 2014Journal of clinical oncology : official journal of the American Society of Clinical Oncologycited by 68
PMID 24323034PMC3887479DOI 10.1200/jco.2012.48.6431PUB-24323034
Rights unknown
Indexing hint: Clinical trial · 2013
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.
Dean et al. 2013The Journal of clinical endocrinology and metabolismcited by 22
PMID 23533230PMC4430583DOI 10.1210/jc.2012-3856PUB-23533230
Rights unknown
Other registry references
References listed at the registry that are not in PepBank. They link to PubMed.
- DerivedTamae 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. PMID 23851165
Eligibility
Who could join, as posted.
- Sex
- Male
- Age
- from 18 Years up to 100 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
1. 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
2. Patient's tumor must be considered surgically resectable .
3. Eastern Cooperative Group (ECOG) performance status of 0-1.
4. Life expectancy greater than 2 years.
5. Able to understand and give informed consent.
6. Laboratory values must be within specified limits.
Exclusion Criteria:
1. Patients with locally advanced or high risk disease not meeting the criteria defined above.
2. Patients who have a total testosterone less than 280 ng/dL.
3. Patients who are receiving any other investigational therapy.
4. Patients with an active serious infection or other serious underlying medical condition.
5. Dementia or significantly altered mental status that would prohibit the understanding and/or giving of informed consent.
6. Histologic evidence of small cell carcinoma of the prostate.
7. Patients who are currently receiving active therapy for other neoplastic disorders.
8. Patients who are receiving any androgens, estrogens or progestational agents.
9. Patients who are taking drugs or herbal supplements which affect androgen metabolism (e.g., spironolactone, aprepitant, bexarotene, clarithromycin, itraconazole, ketoconazole, St. John's wort).
10. Patients who have chronic active hepatitis.
11. 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.
12. Patients who have history of cerebrovascular accident, deep venous thrombosis, pulmonary emboli, unstable angina or clinical congestive heart failure.
13. Medical conditions, which, in the opinion of the investigators would jeopardize either the patient or the integrity of the data obtained.
14. Patients unwilling to use contraceptives while on study.
15. 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.
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