Trial Outcomes & Findings for Finasteride in Treating Patients With Stage II Prostate Cancer Who Are Undergoing Surgery (NCT NCT00438464)
NCT ID: NCT00438464
Last Updated: 2016-03-09
Results Overview
Molecular marker expression based on tissue microarray (TMA) derived from dominant tumor focus. 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: vascular epithelial growth factor (VEFG), estrogen receptor beta (ERβ), androgen receptor (AR), 3-oxo-5α-steroid 4-dehydrogenase 2 (SRD5A2), ubiquitin-conjugating enzyme E2C (UBE2C), and Cleaved Caspase 3 (Caspase). P values are based on non-parametric Wilcoxon rank-sum test.
COMPLETED
PHASE2
204 participants
At prostatectomy following maximum 6 week treatment period
2016-03-09
Participant Flow
Recruitment period: From 2007 to 2012 recruitment was done at various medical clinic locations.
Of the 210 participants recruited, 204 were randomized to the study.
Participant milestones
| Measure |
Arm I (Finasteride)
Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
|
Arm II (Placebo)
Placebo once daily for 4-6 weeks, then undergo prostatectomy.
|
|---|---|---|
|
Overall Study
STARTED
|
103
|
101
|
|
Overall Study
Received Assigned Intervention
|
89
|
94
|
|
Overall Study
COMPLETED
|
89
|
94
|
|
Overall Study
NOT COMPLETED
|
14
|
7
|
Reasons for withdrawal
| Measure |
Arm I (Finasteride)
Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
|
Arm II (Placebo)
Placebo once daily for 4-6 weeks, then undergo prostatectomy.
|
|---|---|---|
|
Overall Study
Terminated Early
|
14
|
5
|
|
Overall Study
Incomplete data submission
|
0
|
2
|
Baseline Characteristics
Finasteride in Treating Patients With Stage II Prostate Cancer Who Are Undergoing Surgery
Baseline characteristics by cohort
| Measure |
Arm I (Finasteride)
n=89 Participants
Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
|
Arm II (Placebo)
n=94 Participants
Placebo once daily for 4-6 weeks, then undergo prostatectomy.
|
Total
n=183 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59 years
n=5 Participants
|
62 years
n=7 Participants
|
60 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
89 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
183 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
5 participants
n=5 Participants
|
7 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
5 participants
n=5 Participants
|
2 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
78 participants
n=5 Participants
|
85 participants
n=7 Participants
|
163 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
89 participants
n=5 Participants
|
94 participants
n=7 Participants
|
183 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At prostatectomy following maximum 6 week treatment periodPopulation: Of total 183 enrolled participants in both arms, 62 Finasteride and 68 Placebo participants respectively had a qualifying tumor specimen with GG3 or GG4. Differences in number (N) of tissue specimens (tumor foci) is based on feasibility of subgroup participants' radical prostatectomy samples analyzed.
Molecular marker expression based on tissue microarray (TMA) derived from dominant tumor focus. 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: vascular epithelial growth factor (VEFG), estrogen receptor beta (ERβ), androgen receptor (AR), 3-oxo-5α-steroid 4-dehydrogenase 2 (SRD5A2), ubiquitin-conjugating enzyme E2C (UBE2C), and Cleaved Caspase 3 (Caspase). P values are based on non-parametric Wilcoxon rank-sum test.
Outcome measures
| Measure |
Arm II (Placebo)
n=68 Participants
Placebo once daily for 4-6 weeks, then undergo prostatectomy.
|
Arm I (Finasteride)
n=62 Participants
Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
|
|---|---|---|
|
Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 3 (GG3) Biomarker Subgroups at Prostatectomy
VEGF (N=37,55)
|
90 Percentage tumor cell involvement
Interval 0.0 to 100.0
|
80 Percentage tumor cell involvement
Interval 5.0 to 100.0
|
|
Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 3 (GG3) Biomarker Subgroups at Prostatectomy
ERβ (N=35, 55)
|
6.6 Percentage tumor cell involvement
Interval 0.0 to 56.3
|
15.0 Percentage tumor cell involvement
Interval 0.03 to 59.0
|
|
Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 3 (GG3) Biomarker Subgroups at Prostatectomy
AR (N=35, 54)
|
78.3 Percentage tumor cell involvement
Interval 33.8 to 97.6
|
75.2 Percentage tumor cell involvement
Interval 21.5 to 92.1
|
|
Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 3 (GG3) Biomarker Subgroups at Prostatectomy
Ki-67 (N=37,54)
|
1.3 Percentage tumor cell involvement
Interval 0.03 to 4.5
|
1.1 Percentage tumor cell involvement
Interval 0.05 to 5.4
|
|
Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 3 (GG3) Biomarker Subgroups at Prostatectomy
SRD5A2 (N=45,47)
|
90 Percentage tumor cell involvement
Interval 0.0 to 100.0
|
100 Percentage tumor cell involvement
Interval 0.0 to 100.0
|
|
Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 3 (GG3) Biomarker Subgroups at Prostatectomy
UBE2C (N=34,55)
|
0.3 Percentage tumor cell involvement
Interval 0.0 to 2.4
|
0.4 Percentage tumor cell involvement
Interval 0.0 to 1.5
|
|
Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 3 (GG3) Biomarker Subgroups at Prostatectomy
Caspase (N=38,55)
|
0.08 Percentage tumor cell involvement
Interval 0.0 to 0.8
|
0.2 Percentage tumor cell involvement
Interval 0.01 to 4.1
|
PRIMARY outcome
Timeframe: At prostatectomy following maximum 6 week treatment periodPopulation: Of total 183 enrolled participants in both arms, 62 Finasteride and 68 Placebo participants respectively had a qualifying tumor specimen with GG3 or GG4. Differences in number (N) of tissue specimens (tumor foci) is based on feasibility of subgroup participants' radical prostatectomy samples analyzed.
Biomarkers using 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. P values are based on non-parametric Wilcoxon rank-sum test.
Outcome measures
| Measure |
Arm II (Placebo)
n=68 Participants
Placebo once daily for 4-6 weeks, then undergo prostatectomy.
|
Arm I (Finasteride)
n=62 Participants
Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
|
|---|---|---|
|
Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 4 (GG4) Biomarker Subgroup at Prostatectomy
VEGF (N=48,61)
|
70 Percentage of tumor cell involvement
Interval 0.0 to 100.0
|
85 Percentage of tumor cell involvement
Interval 5.0 to 100.0
|
|
Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 4 (GG4) Biomarker Subgroup at Prostatectomy
ERβ (N=48,62)
|
9.5 Percentage of tumor cell involvement
Interval 0.0 to 72.8
|
8.0 Percentage of tumor cell involvement
Interval 0.0 to 49.6
|
|
Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 4 (GG4) Biomarker Subgroup at Prostatectomy
AR (N=48,62)
|
75.9 Percentage of tumor cell involvement
Interval 1.4 to 96.6
|
63.71 Percentage of tumor cell involvement
Interval 13.5 to 92.0
|
|
Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 4 (GG4) Biomarker Subgroup at Prostatectomy
Ki-67 (N=48,62)
|
1.4 Percentage of tumor cell involvement
Interval 0.05 to 7.3
|
1.3 Percentage of tumor cell involvement
Interval 0.05 to 7.2
|
|
Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 4 (GG4) Biomarker Subgroup at Prostatectomy
SRD5A2 (N=38,69)
|
90 Percentage of tumor cell involvement
Interval 0.0 to 100.0
|
95 Percentage of tumor cell involvement
Interval 0.0 to 100.0
|
|
Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 4 (GG4) Biomarker Subgroup at Prostatectomy
UBE2C (N=46,62)
|
0.3 Percentage of tumor cell involvement
Interval 0.0 to 2.3
|
0.3 Percentage of tumor cell involvement
Interval 0.0 to 1.6
|
|
Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 4 (GG4) Biomarker Subgroup at Prostatectomy
Caspase (N=47,61)
|
0.04 Percentage of tumor cell involvement
Interval 0.0 to 0.6
|
0.06 Percentage of tumor cell involvement
Interval 0.0 to 0.5
|
PRIMARY outcome
Timeframe: At prostatectomy following maximum 6 week treatment period.Population: Of total 183 enrolled participants in both arms, 62 Finasteride and 68 Placebo participants respectively had a qualifying tumor specimen with GG3 or GG4. Differences in number (N) of tissue specimens (tumor foci) is based on feasibility of subgroup participants' radical prostatectomy samples analyzed.
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.
Outcome measures
| Measure |
Arm II (Placebo)
n=68 Participants
Placebo once daily for 4-6 weeks, then undergo prostatectomy.
|
Arm I (Finasteride)
n=62 Participants
Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
|
|---|---|---|
|
Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 3 (GG3) Biomarker Subgroups at Prostatectomy
VEGF (N=37,55)
|
63.7 Percentage of tumor cell involvement
Standard Deviation 38
|
63.9 Percentage of tumor cell involvement
Standard Deviation 36.3
|
|
Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 3 (GG3) Biomarker Subgroups at Prostatectomy
ERβ (N=35, 55)
|
14.8 Percentage of tumor cell involvement
Standard Deviation 14.7
|
18.1 Percentage of tumor cell involvement
Standard Deviation 15.6
|
|
Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 3 (GG3) Biomarker Subgroups at Prostatectomy
AR (N=35, 54)
|
72.4 Percentage of tumor cell involvement
Standard Deviation 16.7
|
69.8 Percentage of tumor cell involvement
Standard Deviation 17.3
|
|
Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 3 (GG3) Biomarker Subgroups at Prostatectomy
Ki-67 (N=37,54)
|
1.5 Percentage of tumor cell involvement
Standard Deviation 1.0
|
1.6 Percentage of tumor cell involvement
Standard Deviation 1.4
|
|
Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 3 (GG3) Biomarker Subgroups at Prostatectomy
SRD5A2 (N=45,47)
|
64.7 Percentage of tumor cell involvement
Standard Deviation 43.7
|
72.9 Percentage of tumor cell involvement
Standard Deviation 37.0
|
|
Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 3 (GG3) Biomarker Subgroups at Prostatectomy
UBE2C (N=34,55)
|
0.5 Percentage of tumor cell involvement
Standard Deviation 0.5
|
0.5 Percentage of tumor cell involvement
Standard Deviation 0.4
|
|
Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 3 (GG3) Biomarker Subgroups at Prostatectomy
Caspase (N=38,55)
|
0.2 Percentage of tumor cell involvement
Standard Deviation 0.2
|
0.4 Percentage of tumor cell involvement
Standard Deviation 0.7
|
PRIMARY outcome
Timeframe: At prostatectomy following maximum 6 week treatment period.Population: Of total 183 enrolled participants in both arms, 62 Finasteride and 68 Placebo participants respectively had a qualifying tumor specimen with GG3 or GG4. Differences in number (N) of tissue specimens (tumor foci) is based on feasibility of subgroup participants' radical prostatectomy samples analyzed.
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.
Outcome measures
| Measure |
Arm II (Placebo)
n=68 Participants
Placebo once daily for 4-6 weeks, then undergo prostatectomy.
|
Arm I (Finasteride)
n=62 Participants
Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
|
|---|---|---|
|
Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 4 (GG4) Biomarker Subgroup at Prostatectomy
Ki-67 (N=48,62)
|
1.7 Percentage of tumor cell involvement
Standard Deviation 1.4
|
1.8 Percentage of tumor cell involvement
Standard Deviation 1.6
|
|
Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 4 (GG4) Biomarker Subgroup at Prostatectomy
VEGF (N=48,61)
|
59.8 Percentage of tumor cell involvement
Standard Deviation 35.4
|
63.6 Percentage of tumor cell involvement
Standard Deviation 35.5
|
|
Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 4 (GG4) Biomarker Subgroup at Prostatectomy
ERβ (N=48,62)
|
16.7 Percentage of tumor cell involvement
Standard Deviation 18.8
|
15.0 Percentage of tumor cell involvement
Standard Deviation 15.1
|
|
Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 4 (GG4) Biomarker Subgroup at Prostatectomy
AR (N=48,62)
|
68.6 Percentage of tumor cell involvement
Standard Deviation 23.1
|
64.3 Percentage of tumor cell involvement
Standard Deviation 16.67
|
|
Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 4 (GG4) Biomarker Subgroup at Prostatectomy
SRD5A2 (N=38,69)
|
64.9 Percentage of tumor cell involvement
Standard Deviation 40.8
|
71.8 Percentage of tumor cell involvement
Standard Deviation 37.6
|
|
Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 4 (GG4) Biomarker Subgroup at Prostatectomy
UBE2C (N=46,62)
|
0.5 Percentage of tumor cell involvement
Standard Deviation 0.4
|
0.5 Percentage of tumor cell involvement
Standard Deviation 0.4
|
|
Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 4 (GG4) Biomarker Subgroup at Prostatectomy
Caspase (N=47,61)
|
0.06 Percentage of tumor cell involvement
Standard Deviation 0.08
|
0.1 Percentage of tumor cell involvement
Standard Deviation 0.1
|
SECONDARY outcome
Timeframe: Assessment following maximum 6 week treatment period and prostatectomyPopulation: Analysis includes all evaluable participants. One participant in each arm was excluded due to hormonal therapy effect resulting in lack of assignment of Gleason Grade.
Frequency of Grade 3 and Grade 4 tumors in two treatment groups: Participants consist of men with adenocarcinoma of prostate, clinical stage T1c or T2, with Gleason score of 6 or 7 and PSA level \< 10 ng/mL, who are scheduled to undergo prostatectomy. 2005 International Society of Urological Pathologists recommendations for Gleason scoring (GS) used to grade tumors based upon its microscopic appearance: a primary grade is assigned to most common tumor pattern, and a second grade to next most common tumor pattern. Gleason score (GS) is sum of the two Gleason grades, based on scale of 2-10 with lowest numbers indicating slow-growing tumor unlikely to spread and highest numbers indicating an aggressive tumor. Gleason grade = 1-5; Gleason score = 2-10; 5 and 10 indicate worst prognosis. American Joint Committee on Cancer (AJCC) staging describes extent of disease progression utilizing TNM scoring system: Tumor size, Lymph Nodes affected, Metastases. Higher stage cancers are more advanced.
Outcome measures
| Measure |
Arm II (Placebo)
n=93 Participants
Placebo once daily for 4-6 weeks, then undergo prostatectomy.
|
Arm I (Finasteride)
n=88 Participants
Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
|
|---|---|---|
|
Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Score
Gleason Score 6
|
10 participants
|
12 participants
|
|
Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Score
Gleason Score 7
|
78 participants
|
71 participants
|
|
Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Score
Gleason Score 8
|
1 participants
|
2 participants
|
|
Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Score
Gleason Score 9
|
4 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Assessment following maximum 6 week treatment period and prostatectomyPopulation: Analysis includes all evaluable participants. One participant in each arm was excluded due to hormonal therapy effect resulting in lack of assignment of Gleason Grade.
Frequency of Grade 3 and Grade 4 tumors in two treatment groups: Participants consist of men with adenocarcinoma of the prostate, clinical stage T1c or T2, with a Gleason score of 6 or 7 and a PSA level \< 10 ng/mL, who are scheduled to undergo prostatectomy.
Outcome measures
| Measure |
Arm II (Placebo)
n=93 Participants
Placebo once daily for 4-6 weeks, then undergo prostatectomy.
|
Arm I (Finasteride)
n=88 Participants
Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
|
|---|---|---|
|
Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Grade -- Specimen (Primary)
Grade 3
|
75 participants
|
65 participants
|
|
Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Grade -- Specimen (Primary)
Grade 4
|
18 participants
|
23 participants
|
SECONDARY outcome
Timeframe: Assessment following maximum 6 week treatment period and prostatectomyPopulation: Analysis includes all evaluable participants. One participant in each arm was excluded due to hormonal therapy effect resulting in lack of assignment of Gleason Grade.
Frequency of Grade 3, Grade 4 and Grade 5 tumors in two treatment groups: Participants will consist of men with adenocarcinoma of the prostate, clinical stage T1c or T2, with a Gleason score of 6 or 7 and a PSA level \< 10 ng/mL, who are scheduled to undergo prostatectomy.
Outcome measures
| Measure |
Arm II (Placebo)
n=93 Participants
Placebo once daily for 4-6 weeks, then undergo prostatectomy.
|
Arm I (Finasteride)
n=88 Participants
Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
|
|---|---|---|
|
Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Grade -- Specimen (Secondary)
Grade 3
|
24 participants
|
31 participants
|
|
Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Grade -- Specimen (Secondary)
Grade 4
|
64 participants
|
53 participants
|
|
Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Grade -- Specimen (Secondary)
Grade 5
|
5 participants
|
4 participants
|
SECONDARY outcome
Timeframe: Assessment following maximum 6 week treatment period and prostatectomyPopulation: All evaluable participants.
American Joint Committee on Cancer (AJCC) system 6th edition (2002) describing amount and spread of cancer body, using TNM. T describes the size of the tumor and any spread of cancer into nearby tissue; N describes spread of cancer to nearby lymph nodes; and M describes metastasis (spread of cancer to other parts of the body). Numbers after the T (such as T1, T2, T3, and T4) describe tumor size and/or amount of spread into nearby structures. The higher the T number, the larger the tumor and/or the more it has grown into nearby tissues where T3a reflects tumor has spread through the capsule on one or both sides; and T3b reflects tumor has invaded one or both seminal vesicles.
Outcome measures
| Measure |
Arm II (Placebo)
n=94 Participants
Placebo once daily for 4-6 weeks, then undergo prostatectomy.
|
Arm I (Finasteride)
n=89 Participants
Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
|
|---|---|---|
|
Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Tumor, Node, Metastasis (TNM) Stage
pT2
|
74 participants
|
73 participants
|
|
Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Tumor, Node, Metastasis (TNM) Stage
pT3a
|
15 participants
|
11 participants
|
|
Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Tumor, Node, Metastasis (TNM) Stage
pT3b
|
5 participants
|
5 participants
|
SECONDARY outcome
Timeframe: Assessment following maximum 6 week treatment period and prostatectomyPopulation: Analysis includes all evaluable participants.
Edge or border of tissue removed in cancer surgery. The margin is described as negative or clean when the pathologist finds no cancer cells at the edge of the tissue, suggesting that all of the cancer has been removed. The margin is described as positive or involved when the pathologist finds cancer cells at the edge of the tissue, suggesting that all of the cancer has not been removed.
Outcome measures
| Measure |
Arm II (Placebo)
n=94 Participants
Placebo once daily for 4-6 weeks, then undergo prostatectomy.
|
Arm I (Finasteride)
n=89 Participants
Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
|
|---|---|---|
|
Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Margin of Resection (MOR)
Positive
|
16 participants
|
17 participants
|
|
Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Margin of Resection (MOR)
Negative
|
76 participants
|
67 participants
|
|
Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Margin of Resection (MOR)
Equivocal
|
2 participants
|
5 participants
|
SECONDARY outcome
Timeframe: Assessment following maximum 6 week treatment period and prostatectomyPopulation: Analysis includes all evaluable participants.
Status of cancer spread to lymph nodes; PN0 Cancer that has not spread to the lymph nodes. Cancer that has not spread to the lymph nodes. The N category describes whether the cancer has spread into nearby lymph nodes. NX means the nearby lymph nodes cannot be evaluated. N0 means nearby lymph nodes do not contain cancer. Numbers after the N (such as N1, N2, and N3) describe the size, location, and/or the number of nearby lymph nodes affected by cancer. The higher the N number, the greater the cancer spread to nearby lymph nodes.
Outcome measures
| Measure |
Arm II (Placebo)
n=94 Participants
Placebo once daily for 4-6 weeks, then undergo prostatectomy.
|
Arm I (Finasteride)
n=89 Participants
Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
|
|---|---|---|
|
Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Lymph Node Status
PN0
|
43 participants
|
46 participants
|
|
Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Lymph Node Status
PN1
|
2 participants
|
2 participants
|
|
Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Lymph Node Status
pNX
|
49 participants
|
41 participants
|
SECONDARY outcome
Timeframe: Assessment following maximum 6 week treatment period and prostatectomyPopulation: Analysis includes all evaluable participants.
Diagnosis of a small focus of prostatic adenocarcinoma on a prostate needle biopsy from pathologist's identification of an architecturally abnormal focus of epithelial structures at rather low magnification.
Outcome measures
| Measure |
Arm II (Placebo)
n=94 Participants
Placebo once daily for 4-6 weeks, then undergo prostatectomy.
|
Arm I (Finasteride)
n=89 Participants
Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
|
|---|---|---|
|
Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Cancer Foci
1 Focus
|
11 participants
|
15 participants
|
|
Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Cancer Foci
2 Foci
|
20 participants
|
18 participants
|
|
Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Cancer Foci
3 Foci
|
28 participants
|
28 participants
|
|
Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Cancer Foci
4 Foci
|
20 participants
|
13 participants
|
|
Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Cancer Foci
>/= 5 Foci
|
15 participants
|
15 participants
|
SECONDARY outcome
Timeframe: Assessment following maximum 6 week treatment period and prostatectomyPopulation: Analysis includes all evaluable participants.
Tumor distribution within zones of the prostate using radical prostatectomy specimen (RPS) where number of foci categorized by zone defined as: PZ, peripheral zone; TZ, transition zone; CZ, central zone.
Outcome measures
| Measure |
Arm II (Placebo)
n=94 Participants
Placebo once daily for 4-6 weeks, then undergo prostatectomy.
|
Arm I (Finasteride)
n=89 Participants
Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
|
|---|---|---|
|
Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Zonal Origin of Tumor Foci Per Radical Prostatectomy Specimen (RPS)
PZ
|
38 participants
|
35 participants
|
|
Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Zonal Origin of Tumor Foci Per Radical Prostatectomy Specimen (RPS)
PZ + TZ
|
50 participants
|
49 participants
|
|
Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Zonal Origin of Tumor Foci Per Radical Prostatectomy Specimen (RPS)
PZ + TZ + CZ
|
2 participants
|
2 participants
|
|
Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Zonal Origin of Tumor Foci Per Radical Prostatectomy Specimen (RPS)
PZ + CZ
|
1 participants
|
0 participants
|
|
Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Zonal Origin of Tumor Foci Per Radical Prostatectomy Specimen (RPS)
TZ
|
3 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Assessment following maximum 6 week treatment period and prostatectomyPopulation: Analysis includes all evaluable participants.
Dominant tumor focus, distribution within zones of the prostate using radical prostatectomy specimen (RPS) where number of foci categorized by zone defined as: PZ, peripheral zone; TZ, transition zone; CZ, central zone. Dominant tumor focus is the largest, index lesion, single high risk focus of the prostate cancer.
Outcome measures
| Measure |
Arm II (Placebo)
n=94 Participants
Placebo once daily for 4-6 weeks, then undergo prostatectomy.
|
Arm I (Finasteride)
n=89 Participants
Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
|
|---|---|---|
|
Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Zonal Origin -- Dominant Tumor Focus
PZ
|
73 participants
|
67 participants
|
|
Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Zonal Origin -- Dominant Tumor Focus
TZ
|
21 participants
|
22 participants
|
SECONDARY outcome
Timeframe: Baseline biopsy to prostatectomy following maximum 6 week treatment periodPopulation: Analysis includes all evaluable participants.
Change in Gleason Score from biopsy to prostatectomy where an upgrade refers to a higher Gleason Score signifying worsening of tumor. Gleason scoring (GS) to based on microscopic appearance using 2005 International Society of Urological Pathologists recommendation.
Outcome measures
| Measure |
Arm II (Placebo)
n=94 Participants
Placebo once daily for 4-6 weeks, then undergo prostatectomy.
|
Arm I (Finasteride)
n=89 Participants
Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
|
|---|---|---|
|
Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Upgrade Between Biopsy and Prostatectomy
Yes
|
24 participants
|
26 participants
|
|
Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Upgrade Between Biopsy and Prostatectomy
No
|
70 participants
|
63 participants
|
SECONDARY outcome
Timeframe: Baseline biopsy to prostatectomy following maximum 6 week treatment periodPopulation: Analysis includes all evaluable participants.
Characteristics of tumor considering total zone cancer volume, and cancer volume using zonal foci categorized as: PZ, peripheral zone; TZ, transition zone; CZ, central zone.
Outcome measures
| Measure |
Arm II (Placebo)
n=94 Participants
Placebo once daily for 4-6 weeks, then undergo prostatectomy.
|
Arm I (Finasteride)
n=89 Participants
Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
|
|---|---|---|
|
Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Tumor Volume (Cubic Centimeter)
Total
|
0.8 cubic centimeter
Interval 0.0 to 10.4
|
1.0 cubic centimeter
Interval 0.0 to 9.3
|
|
Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Tumor Volume (Cubic Centimeter)
PZ Cancer focus/foci
|
0.5 cubic centimeter
Interval 0.0 to 9.0
|
0.6 cubic centimeter
Interval 0.0 to 9.3
|
|
Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Tumor Volume (Cubic Centimeter)
TZ cancer focus/foci
|
0.0 cubic centimeter
Interval 0.0 to 10.4
|
0.0 cubic centimeter
Interval 0.0 to 6.0
|
SECONDARY outcome
Timeframe: Baseline biopsy to prostatectomy following maximum 6 week treatment periodPopulation: Analysis includes all evaluable participants.
Characteristics of blood biomarkers using pretreatment and posttreatment values. Prostate-specific antigen (PSA) blood test measuring protein produced by prostate cells.
Outcome measures
| Measure |
Arm II (Placebo)
n=80 Participants
Placebo once daily for 4-6 weeks, then undergo prostatectomy.
|
Arm I (Finasteride)
n=75 Participants
Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
|
|---|---|---|
|
Characteristics of Blood Biomarkers: Prostate-specific Antigen (ng/mL) Percentage Change (%)
|
-4.6 percentage of change
Interval -61.2 to 200.0
|
-39.4 percentage of change
Interval -96.6 to 155.2
|
SECONDARY outcome
Timeframe: Baseline biopsy to prostatectomy following maximum 6 week treatment periodPopulation: Analysis includes all evaluable participants.
Characteristics of blood biomarkers using pretreatment and posttreatment values. Blood tests used for measuring the amount of testosterone in the blood.
Outcome measures
| Measure |
Arm II (Placebo)
n=80 Participants
Placebo once daily for 4-6 weeks, then undergo prostatectomy.
|
Arm I (Finasteride)
n=76 Participants
Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
|
|---|---|---|
|
Characteristics of Blood Biomarkers: Testosterone (ng/dL) Percentage Change
|
-4.6 percentage of change
Interval -80.7 to 76.1
|
13 percentage of change
Interval -53.0 to 158.0
|
SECONDARY outcome
Timeframe: Baseline biopsy to prostatectomy following maximum 6 week treatment periodPopulation: Analysis includes all evaluable participants.
Characteristics of blood biomarkers using pretreatment and posttreatment values. Dihydrotestosterone (DHT) blood test measures serum concentrations of dihydrotestosterone and is closely related to those of testosterone.
Outcome measures
| Measure |
Arm II (Placebo)
n=79 Participants
Placebo once daily for 4-6 weeks, then undergo prostatectomy.
|
Arm I (Finasteride)
n=74 Participants
Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
|
|---|---|---|
|
Characteristics of Blood Biomarkers: Dihydrotestosterone (ng/dL) Percentage Change
|
-3.6 percentage of change
Interval -64.7 to 615.1
|
-64.8 percentage of change
Interval -90.0 to 120.0
|
SECONDARY outcome
Timeframe: Baseline biopsy to prostatectomy following maximum 6 week treatment periodPopulation: Analysis includes all evaluable participants.
Characteristics of blood biomarkers using pretreatment and posttreatment values. Blood test used to measure Estrone (E1), one of the three estrogens, which also includes estriol and estradiol.
Outcome measures
| Measure |
Arm II (Placebo)
n=79 Participants
Placebo once daily for 4-6 weeks, then undergo prostatectomy.
|
Arm I (Finasteride)
n=75 Participants
Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
|
|---|---|---|
|
Characteristics of Blood Biomarkers: Estrone (ng/dL) Percentage Change
|
0 percentage of change
Interval -81.8 to 760.0
|
-8.9 percentage of change
Interval -93.2 to 870.0
|
SECONDARY outcome
Timeframe: Baseline biopsy to prostatectomy following maximum 6 week treatment periodPopulation: Analysis includes all evaluable participants.
Characteristics of blood biomarkers using pretreatment and posttreatment values. Blood test used to measure Estradiol.
Outcome measures
| Measure |
Arm II (Placebo)
n=79 Participants
Placebo once daily for 4-6 weeks, then undergo prostatectomy.
|
Arm I (Finasteride)
n=76 Participants
Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
|
|---|---|---|
|
Characteristics of Blood Biomarkers: Estradiol (ng/dL) Percentage Change
|
0 percentage of change
Interval -86.8 to 161.5
|
7.2 percentage of change
Interval -80.0 to 700.0
|
SECONDARY outcome
Timeframe: At prostatectomy following maximum 6 week treatment periodPopulation: Of total 89 enrolled participants in the Finasteride Arm, 62 participants had either a qualifying tumor specimen with GG3 or GG4. Differences in number (N) of tissue specimens (tumor foci) is based on feasibility of subgroup participants' radical prostatectomy samples analyzed.
Molecular marker expression compared between tumor foci, characteristics of blood biomarkers using pretreatment and posttreatment values. 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.
Outcome measures
| Measure |
Arm II (Placebo)
n=62 Participants
Placebo once daily for 4-6 weeks, then undergo prostatectomy.
|
Arm I (Finasteride)
n=62 Participants
Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
|
|---|---|---|
|
Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Finasteride Treatment Arm for Biomarker Subgroups (Mean)
VEGF (N=37,48)
|
63.7 Percentage of tumor cell involvement
Standard Deviation 35.5
|
63.9 Percentage of tumor cell involvement
Standard Deviation 36.3
|
|
Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Finasteride Treatment Arm for Biomarker Subgroups (Mean)
ERβ (N=35,48)
|
15.0 Percentage of tumor cell involvement
Standard Deviation 15.1
|
18.1 Percentage of tumor cell involvement
Standard Deviation 15.6
|
|
Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Finasteride Treatment Arm for Biomarker Subgroups (Mean)
AR (N=35,48)
|
64.3 Percentage of tumor cell involvement
Standard Deviation 16.7
|
69.8 Percentage of tumor cell involvement
Standard Deviation 17.3
|
|
Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Finasteride Treatment Arm for Biomarker Subgroups (Mean)
Ki-67 (N=37,48)
|
1.8 Percentage of tumor cell involvement
Standard Deviation 1.6
|
1.6 Percentage of tumor cell involvement
Standard Deviation 1.4
|
|
Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Finasteride Treatment Arm for Biomarker Subgroups (Mean)
SRD5A2 (N=45,38)
|
71.8 Percentage of tumor cell involvement
Standard Deviation 37.6
|
72.9 Percentage of tumor cell involvement
Standard Deviation 37.0
|
|
Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Finasteride Treatment Arm for Biomarker Subgroups (Mean)
UBE2C (N=34,46)
|
0.5 Percentage of tumor cell involvement
Standard Deviation 0.4
|
0.5 Percentage of tumor cell involvement
Standard Deviation 0.4
|
|
Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Finasteride Treatment Arm for Biomarker Subgroups (Mean)
Caspase (N=38,47)
|
0.1 Percentage of tumor cell involvement
Standard Deviation 0.1
|
0.4 Percentage of tumor cell involvement
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: At prostatectomy following maximum 6 week treatment period.Population: Of total 94 enrolled participants in the Placebo Arm, 68 participants had either a qualifying tumor specimen with GG3 or GG4. Differences in number (N) of tissue specimens (tumor foci) is based on feasibility of subgroup participants' radical prostatectomy samples analyzed.
Molecular marker expression compared between tumor foci, characteristics of blood biomarkers using pretreatment and posttreatment values. 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.
Outcome measures
| Measure |
Arm II (Placebo)
n=68 Participants
Placebo once daily for 4-6 weeks, then undergo prostatectomy.
|
Arm I (Finasteride)
n=68 Participants
Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
|
|---|---|---|
|
Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Placebo Treatment Arm for Biomarker Subgroups (Mean)
VEGF (N=55,61)
|
59.7 Percentage of tumor cell involvement
Standard Deviation 35.4
|
63.7 Percentage of tumor cell involvement
Standard Deviation 38
|
|
Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Placebo Treatment Arm for Biomarker Subgroups (Mean)
ERβ (N=55,62)
|
16.7 Percentage of tumor cell involvement
Standard Deviation 18.8
|
14.8 Percentage of tumor cell involvement
Standard Deviation 14.7
|
|
Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Placebo Treatment Arm for Biomarker Subgroups (Mean)
AR (N=54,62)
|
68.6 Percentage of tumor cell involvement
Standard Deviation 23.1
|
72.4 Percentage of tumor cell involvement
Standard Deviation 16.7
|
|
Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Placebo Treatment Arm for Biomarker Subgroups (Mean)
Ki-67 (N=54,62)
|
1.7 Percentage of tumor cell involvement
Standard Deviation 1.4
|
1.5 Percentage of tumor cell involvement
Standard Deviation 1.0
|
|
Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Placebo Treatment Arm for Biomarker Subgroups (Mean)
SRD5A2 (N=47,69)
|
64.9 Percentage of tumor cell involvement
Standard Deviation 40.8
|
64.7 Percentage of tumor cell involvement
Standard Deviation 43.7
|
|
Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Placebo Treatment Arm for Biomarker Subgroups (Mean)
UBE2C (N=55,62)
|
0.5 Percentage of tumor cell involvement
Standard Deviation 0.4
|
0.5 Percentage of tumor cell involvement
Standard Deviation 0.5
|
|
Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Placebo Treatment Arm for Biomarker Subgroups (Mean)
Caspase (N=55,61)
|
0.06 Percentage of tumor cell involvement
Standard Deviation 0.08
|
0.2 Percentage of tumor cell involvement
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: At prostatectomy following maximum 6 week treatment periodPopulation: Of total 89 enrolled participants in the Finasteride Arm, 62 participants had either a qualifying tumor specimen with GG3 or GG4. Differences in number (N) of tissue specimens (tumor foci) is based on feasibility of subgroup participants' radical prostatectomy samples analyzed.
Molecular marker expression compared between tumor foci, characteristics of blood biomarkers using pretreatment and posttreatment values. 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. P values are based on non-parametric Wilcoxon rank-sum test.
Outcome measures
| Measure |
Arm II (Placebo)
n=62 Participants
Placebo once daily for 4-6 weeks, then undergo prostatectomy.
|
Arm I (Finasteride)
n=62 Participants
Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
|
|---|---|---|
|
Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Finasteride Treatment Arm for Biomarker Subgroups
VEGF (N=37,48)
|
85 Percentage of tumor cell involvement
Interval 5.0 to 100.0
|
80 Percentage of tumor cell involvement
Interval 5.0 to 100.0
|
|
Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Finasteride Treatment Arm for Biomarker Subgroups
ERβ (N=35,48)
|
8.0 Percentage of tumor cell involvement
Interval 0.0 to 49.56
|
15.0 Percentage of tumor cell involvement
Interval 0.03 to 58.9
|
|
Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Finasteride Treatment Arm for Biomarker Subgroups
AR (N=35,48)
|
63.7 Percentage of tumor cell involvement
Interval 13.5 to 92.0
|
75.2 Percentage of tumor cell involvement
Interval 21.5 to 92.1
|
|
Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Finasteride Treatment Arm for Biomarker Subgroups
Ki-67 (N=37,48)
|
1.3 Percentage of tumor cell involvement
Interval 0.05 to 7.2
|
1.1 Percentage of tumor cell involvement
Interval 0.05 to 5.4
|
|
Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Finasteride Treatment Arm for Biomarker Subgroups
SRD5A2 (N=45,38)
|
95 Percentage of tumor cell involvement
Interval 0.0 to 100.0
|
100 Percentage of tumor cell involvement
Interval 0.0 to 100.0
|
|
Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Finasteride Treatment Arm for Biomarker Subgroups
UBE2C (N=34,46)
|
0.3 Percentage of tumor cell involvement
Interval 0.0 to 1.6
|
0.4 Percentage of tumor cell involvement
Interval 0.0 to 1.5
|
|
Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Finasteride Treatment Arm for Biomarker Subgroups
Caspase (N=38,47)
|
0.06 Percentage of tumor cell involvement
Interval 0.0 to 0.5
|
0.2 Percentage of tumor cell involvement
Interval 0.01 to 4.1
|
SECONDARY outcome
Timeframe: At prostatectomy following maximum 6 week treatment period.Population: Of total 94 enrolled participants in the Placebo Arm, 68 participants had either a qualifying tumor specimen with GG3 or GG4. Differences in number (N) of tissue specimens (tumor foci) is based on feasibility of subgroup participants' radical prostatectomy samples analyzed.
Molecular marker expression compared between tumor foci, characteristics of blood biomarkers using pretreatment and posttreatment values. 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. P values are based on non-parametric Wilcoxon rank-sum test.
Outcome measures
| Measure |
Arm II (Placebo)
n=68 Participants
Placebo once daily for 4-6 weeks, then undergo prostatectomy.
|
Arm I (Finasteride)
n=68 Participants
Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
|
|---|---|---|
|
Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Within Placebo Treatment Arm for Biomarker Subgroups
VEGF (N=55,61)
|
70 Percentage of tumor cell involvement
Interval 0.0 to 100.0
|
90 Percentage of tumor cell involvement
Interval 0.0 to 100.0
|
|
Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Within Placebo Treatment Arm for Biomarker Subgroups
ERβ (N=55,62)
|
9.5 Percentage of tumor cell involvement
Interval 0.0 to 72.8
|
6.6 Percentage of tumor cell involvement
Interval 0.0 to 56.3
|
|
Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Within Placebo Treatment Arm for Biomarker Subgroups
AR (N=54,62)
|
75.9 Percentage of tumor cell involvement
Interval 1.39 to 96.6
|
78.3 Percentage of tumor cell involvement
Interval 33.77 to 97.6
|
|
Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Within Placebo Treatment Arm for Biomarker Subgroups
Ki-67 (N=54,62)
|
1.4 Percentage of tumor cell involvement
Interval 0.05 to 7.3
|
1.3 Percentage of tumor cell involvement
Interval 0.03 to 4.5
|
|
Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Within Placebo Treatment Arm for Biomarker Subgroups
SRD5A2 (N=47,69)
|
90 Percentage of tumor cell involvement
Interval 0.0 to 100.0
|
90 Percentage of tumor cell involvement
Interval 0.0 to 100.0
|
|
Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Within Placebo Treatment Arm for Biomarker Subgroups
UBE2C (N=55,62)
|
0.3 Percentage of tumor cell involvement
Interval 0.0 to 2.3
|
0.3 Percentage of tumor cell involvement
Interval 0.0 to 2.4
|
|
Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Within Placebo Treatment Arm for Biomarker Subgroups
Caspase (N=55,61)
|
0.04 Percentage of tumor cell involvement
Interval 0.0 to 0.6
|
0.08 Percentage of tumor cell involvement
Interval 0.0 to 0.8
|
Adverse Events
Arm I (Finasteride)
Arm II (Placebo)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jeri Kim, MD / Associate Professor, Genitourinary Medical Oncology
University of Texas (UT) MD Anderson Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60