A Randomized Controlled Trial Evaluating the Tissue Effects of Preoperative Finasteride Versus Placebo for Patients With Clinically Organ-Confined Prostate Cancer
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 204
- Locations
- 8
- Primary Endpoint
- Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 3 (GG3) Biomarker Subgroups at Prostatectomy
Study Overview
Brief Summary
This randomized phase II trial studies how well finasteride works in treating patients with stage II prostate cancer who are undergoing surgery. Testosterone can cause the growth of prostate cancer cells. Hormone therapy using finasteride may fight prostate cancer by lowering the amount of testosterone the body makes. Giving finasteride before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
Detailed Description
PRIMARY OBJECTIVES:
I. Compare the frequency of discriminating molecular marker expression in Gleason grade (GG) 3 cores, adjusted for Gleason score (GS) at prostatectomy, in patients with stage II prostate cancer treated with neoadjuvant finasteride vs placebo.
SECONDARY OBJECTIVES:
I. Compare the frequency with which grade 3 and grade 4 tumors occur in these patients.
II. Determine the frequency of discriminating molecular signature expression in tissue microarray cores segregated by GS at prostatectomy in these patients.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Arm I (Finasteride)
Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
Intervention: Finasteride (Drug)
Arm I (Finasteride)
Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
Intervention: Prostatectomy (Procedure)
Arm I (Finasteride)
Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
Intervention: Laboratory biomarker analysis (Other)
Arm II (Placebo)
Placebo once daily for 4-6 weeks, then undergo prostatectomy.
Intervention: Placebo (Other)
Arm II (Placebo)
Placebo once daily for 4-6 weeks, then undergo prostatectomy.
Intervention: Laboratory biomarker analysis (Other)
Outcomes
Primary Outcomes
Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 3 (GG3) Biomarker Subgroups at Prostatectomy
Time Frame: At prostatectomy following maximum 6 week treatment period.
Molecular marker expression compared between tumor foci using Biomarkers pretreatment and posttreatment values. Staining microarrays for high-throughput assessment of candidate gene expression and data modeling constructed with a tissue microarray apparatus and 0.6-mm biopsy cores, representative of tumor grades and scores (Gleason Grades 3 (GG3) and Gleason Grade 4 (GG4)). The percentage of tumor cells exhibiting detectable staining, scored as 0 to 10 where higher score designates more involvement, as applicable for: VEGF denotes vascular epithelial growth factor, ERβ estrogen receptor beta, AR androgen receptor, SRD5A2, 3-oxo-5α-steroid 4-dehydrogenase 2, UBE2C, ubiquitin-conjugating enzyme E2C.
Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 4 (GG4) Biomarker Subgroup at Prostatectomy
Time Frame: At prostatectomy following maximum 6 week treatment period.
Molecular marker expression compared between tumor foci using biomarkers pretreatment and posttreatment values. Staining microarrays for high-throughput assessment of candidate gene expression and data modeling constructed with a tissue microarray apparatus and 0.6-mm biopsy cores, representative of tumor grades and scores (Gleason Grades 3 (GG3) and Gleason Grade 4 (GG4)). The percentage of tumor cells exhibiting detectable staining, scored as 0 to 10 where higher score designates more involvement, as applicable for: VEGF denotes vascular epithelial growth factor, ERβ estrogen receptor beta, AR androgen receptor, SRD5A2, 3-oxo-5α-steroid 4-dehydrogenase 2, UBE2C, ubiquitin-conjugating enzyme E2C.
Secondary Outcomes
- Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Zonal Origin of Tumor Foci Per Radical Prostatectomy Specimen (RPS)(Assessment following maximum 6 week treatment period and prostatectomy)
- Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Margin of Resection (MOR)(Assessment following maximum 6 week treatment period and prostatectomy)
- Characteristics of Blood Biomarkers: Estrone (ng/dL) Percentage Change(Baseline biopsy to prostatectomy following maximum 6 week treatment period)
- Characteristics of Blood Biomarkers: Estradiol (ng/dL) Percentage Change(Baseline biopsy to prostatectomy following maximum 6 week treatment period)
- Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Score(Assessment following maximum 6 week treatment period and prostatectomy)
- Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Grade -- Specimen (Primary)(Assessment following maximum 6 week treatment period and prostatectomy)
- Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Grade -- Specimen (Secondary)(Assessment following maximum 6 week treatment period and prostatectomy)
- Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Cancer Foci(Assessment following maximum 6 week treatment period and prostatectomy)
- Characteristics of Blood Biomarkers: Testosterone (ng/dL) Percentage Change(Baseline biopsy to prostatectomy following maximum 6 week treatment period)
- Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Tumor, Node, Metastasis (TNM) Stage(Assessment following maximum 6 week treatment period and prostatectomy)
- Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Lymph Node Status(Assessment following maximum 6 week treatment period and prostatectomy)
- Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Upgrade Between Biopsy and Prostatectomy(Baseline biopsy to prostatectomy following maximum 6 week treatment period)
- Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Tumor Volume (Cubic Centimeter)(Baseline biopsy to prostatectomy following maximum 6 week treatment period)
- Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Zonal Origin -- Dominant Tumor Focus(Assessment following maximum 6 week treatment period and prostatectomy)
- Characteristics of Blood Biomarkers: Prostate-specific Antigen (ng/mL) Percentage Change (%)(Baseline biopsy to prostatectomy following maximum 6 week treatment period)
- Characteristics of Blood Biomarkers: Dihydrotestosterone (ng/dL) Percentage Change(Baseline biopsy to prostatectomy following maximum 6 week treatment period)
- Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Placebo Treatment Arm for Biomarker Subgroups (Mean)(At prostatectomy following maximum 6 week treatment period.)
- Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Finasteride Treatment Arm for Biomarker Subgroups (Mean)(At prostatectomy following maximum 6 week treatment period)
- Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Finasteride Treatment Arm for Biomarker Subgroups(At prostatectomy following maximum 6 week treatment period)
- Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Within Placebo Treatment Arm for Biomarker Subgroups(At prostatectomy following maximum 6 week treatment period.)