Phase 2
N=19
Androgen Deprivation Therapy and Vorinostat Followed by Radical Prostatectomy in Treating Patients With Localized Prostate Cancer
Prostate Adenocarcinoma · Stage I Prostate Cancer · Stage IIA Prostate Cancer · Stage IIB Prostate Cancer · Stage III Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00589472 ↗Enrolled (actual)
19
Serious AEs
10.5%
Results posted
Oct 2017
Primary outcome: Primary: Pathologic Complete Response at the Time of Surgery — 10; 8; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Bicalutamide (Drug); Goserelin Acetate (Drug); Laboratory Biomarker Analysis (Other); Leuprolide Acetate (Drug); Therapeutic Conventional Surgery (Procedure); Vorinostat (Drug)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- Male
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Jun 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pathologic Complete Response at the Time of Surgery |
10; 8; 0 | — |
| SECONDARY Gleason Score |
8 | — |
| SECONDARY Levels of DHEA in Blood From Radical Prostatectomy Specimens |
256 | — |
| SECONDARY Levels of DHEA-S in Blood From Radical Prostatectomy Specimens |
90 | — |
| SECONDARY Levels of DHT in Blood From Radical Prostatectomy Specimens |
24 | — |
| SECONDARY Levels of PSA in Blood From Radical Prostatectomy Specimens |
9.44 | — |
| SECONDARY Levels of Testosterone in Blood From Radical Prostatectomy Specimens |
319 | — |
Summary
This phase II trial studies how well androgen deprivation therapy and vorinostat followed by radical prostatectomy works in treating patients with prostate cancer that has not spread to other parts of the body. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as bicalutamide, goserelin acetate, and leuprolide acetate, may lessen the amount of androgens made by the body. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving androgen deprivation therapy and vorinostat before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
Eligibility Criteria
Inclusion Criteria
- Histologic documentation of prostatic adenocarcinoma in 3 or more biopsy cores, of which at least 1 core demonstrates > 30% involvement with tumor; confirmation of localized disease by magnetic resonance imaging (MRI) with endorectal probe if available
- No evidence of distant disease on a:
- Computed tomography (CT) or MRI of the abdomen and pelvis
- Radionuclide bone scan (with plain film or MRI confirmation as clinically indicated)
- Appropriate candidate for radical prostatectomy
- Adequate cardiac function (evidence of cardiac disease should be evaluated to determine appropriateness of patient as a surgical candidate)
- Candidates may have a history of deep vein thrombosis, pulmonary embolism, and/or cerebrovascular accident, or require concomitant systemic anticoagulation, if otherwise deemed to be suitable for radical prostatectomy
- White blood cell (WBC) > 3000/uL
- Platelets > 150,000/uL
- Creatinine 70%
- Willingness to undergo pretreatment transrectal ultrasound-guided prostate needle biopsy (optional)
- Willingness to use adequate contraceptive methods during study therapy and for at least 3 months after completion of therapy
- Ability to understand and willingness to sign a written informed consent document
Exclusion Criteria
- Evidence of small-cell, transitional-cell, or neuroendocrine pathologic features
- Prior hormonal therapy with (e.g. 5-alpha-reductase inhibitors, gonadotropin hormone releasing analogs, steroids, megestrol acetate, or nonstudy-related antiandrogens), chemotherapy, or herbal medications administered with the intent to treat the patient's malignancy
- Patients on valproic acid (a histone-deacetylase inhibitor) to treat prostate cancer are not eligible
- History of allergic reactions attributed to compounds of similar chemical or biological composition to vorinostat
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situation that would compromise compliance with study requirements
- Currently active secondary malignancy (as determined by the treating physician) other than non-melanoma skin cancer
Data sourced from ClinicalTrials.gov (NCT00589472). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.