Clinical trial · Interventional
Androgen Deprivation Therapy and Vorinostat Followed by Radical Prostatectomy in Treating Patients With Localized Prostate Cancer
Neoadjuvant Androgen Depletion in Combination With Vorinostat Followed by Radical Prostatectomy for Localized Prostate Cancer: Total Androgen-Receptor Gene Expression Targeted Therapy (TARGET)
NCT00589472CI-TRIAL-00029813TARGETcompletedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Adenocarcinoma | Prostate Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Stage IIA Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIB Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage III Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage I Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bicalutamide | Drug | Bicalutamide | ALIAS |
| Goserelin Acetate | Drug | Goserelin | ALIAS |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Leuprolide Acetate | Drug | Leuprolide | ALIAS |
| Therapeutic Conventional Surgery | Procedure | — | UNRESOLVED |
| Vorinostat | Drug | Vorinostat | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (Antihormone therapy and enzyme inhibitor therapy)
- description
- Patients receive bicalutamide PO QD for 1 month and leuprolide acetate IM or goserelin acetate SC once a month until surgery. Patients also receive vorinostat PO QD beginning on the first day of androgen depletion therapy and continuing for up to 8 weeks or until the day of surgery. Patients then undergo an open or laparoscopic radical prostatectomy. Patients with positive surgical margins undergo immediate adjuvant external beam radiotherapy to the prostatic fossa, based on the judgment of the treating physician.
- interventionNames
- Drug: Bicalutamide
- Drug: Goserelin Acetate
- Other: Laboratory Biomarker Analysis
- Drug: Leuprolide Acetate
- Procedure: Therapeutic Conventional Surgery
- Drug: Vorinostat
Primary outcomes (1)
- measure
- Pathologic Complete Response at the Time of Surgery
- timeFrame
- At 12 weeks
- description
- The primary endpoint will be pathologic complete response at the time of surgery. This represents the proportion of patients with no evidence of disease in the prostate (ie, the absence of tumor in the posttherapy pathology specimen) at the time of radical prostatectomy. Pathologic complete response at the time of surgery is the primary endpoint for this study. A Simon 2-stage optimal design that differentiates between response probabilities of 0.05 and 0.20 will be used in the analysis of the pathological complete response at 12 weeks (Type I error 10% and power 90%). A maximum of 38 pts were planned for accrual onto this study. If zero or one response was observed, then the trial was to be stopped. The design had power 0.90 for a population response proportion to 0.20 using a one-sided 0.10 size test. pT2 indicates that the cancer is confined to the prostate, while pT3 indicates that there is an extraprostatic extension of the cancer.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 19 Years
Show eligibility criteria text
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 \< 2 mg/dL * Serum PSA \< 100 ng/mL * Bilirubin \< 1.5 X ULN (institutional upper limits of normal) * Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \< 2 X ULN * Karnofsky performance status \> 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
References
Publications (0)
Data not yet available
No reference posted for this study.