| Secondary | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Score | 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. | 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. | Posted | | Number | | participants | | Assessment following maximum 6 week treatment period and prostatectomy | | | | ID | Title | Description |
|---|
| OG000 | Arm I (Finasteride) | Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy. | | OG001 | Arm II (Placebo) | Placebo once daily for 4-6 weeks, then undergo prostatectomy. |
| | | Title | Denominators | Categories |
|---|
| Gleason Score 6 | | | | Gleason Score 7 | | |
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| Secondary | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Grade -- Specimen (Primary) | 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. | 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. | Posted | | Number | | participants | | Assessment following maximum 6 week treatment period and prostatectomy | | | | ID | Title | Description |
|---|
| OG000 | Arm I (Finasteride) | Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy. | | OG001 | Arm II (Placebo) | Placebo once daily for 4-6 weeks, then undergo prostatectomy. |
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| Secondary | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Grade -- Specimen (Secondary) | 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. | 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. | Posted | | Number | | participants | | Assessment following maximum 6 week treatment period and prostatectomy | | | | ID | Title | Description |
|---|
| OG000 | Arm I (Finasteride) | Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy. | | OG001 | Arm II (Placebo) | Placebo once daily for 4-6 weeks, then undergo prostatectomy. |
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| Secondary | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Tumor, Node, Metastasis (TNM) Stage | 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. | All evaluable participants. | Posted | | Number | | participants | | Assessment following maximum 6 week treatment period and prostatectomy | | | | ID | Title | Description |
|---|
| OG000 | Arm I (Finasteride) | Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy. | | OG001 | Arm II (Placebo) | Placebo once daily for 4-6 weeks, then undergo prostatectomy. |
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| Secondary | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Margin of Resection (MOR) | 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. | Analysis includes all evaluable participants. | Posted | | Number | | participants | | Assessment following maximum 6 week treatment period and prostatectomy | | | | ID | Title | Description |
|---|
| OG000 | Arm I (Finasteride) | Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy. | | OG001 | Arm II (Placebo) | Placebo once daily for 4-6 weeks, then undergo prostatectomy. |
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| Secondary | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Lymph Node Status | 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. | Analysis includes all evaluable participants. | Posted | | Number | | participants | | Assessment following maximum 6 week treatment period and prostatectomy | | | | ID | Title | Description |
|---|
| OG000 | Arm I (Finasteride) | Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy. | | OG001 | Arm II (Placebo) | Placebo once daily for 4-6 weeks, then undergo prostatectomy. |
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| Secondary | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Cancer Foci | 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. | Analysis includes all evaluable participants. | Posted | | Number | | participants | | Assessment following maximum 6 week treatment period and prostatectomy | | | | ID | Title | Description |
|---|
| OG000 | Arm I (Finasteride) | Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy. | | OG001 | Arm II (Placebo) | Placebo once daily for 4-6 weeks, then undergo prostatectomy. |
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| Secondary | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Zonal Origin of Tumor Foci Per Radical Prostatectomy Specimen (RPS) | 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. | Analysis includes all evaluable participants. | Posted | | Number | | participants | | Assessment following maximum 6 week treatment period and prostatectomy | | | | ID | Title | Description |
|---|
| OG000 | Arm I (Finasteride) | Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy. | | OG001 | Arm II (Placebo) | Placebo once daily for 4-6 weeks, then undergo prostatectomy. |
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| Secondary | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Zonal Origin -- Dominant Tumor Focus | 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. | Analysis includes all evaluable participants. | Posted | | Number | | participants | | Assessment following maximum 6 week treatment period and prostatectomy | | | | ID | Title | Description |
|---|
| OG000 | Arm I (Finasteride) | Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy. | | OG001 | Arm II (Placebo) | Placebo once daily for 4-6 weeks, then undergo prostatectomy. |
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| Secondary | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Upgrade Between Biopsy and Prostatectomy | 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. | Analysis includes all evaluable participants. | Posted | | Number | | participants | | Baseline biopsy to prostatectomy following maximum 6 week treatment period | | | | ID | Title | Description |
|---|
| OG000 | Arm I (Finasteride) | Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy. | | OG001 | Arm II (Placebo) | Placebo once daily for 4-6 weeks, then undergo prostatectomy. |
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| Secondary | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Tumor Volume (Cubic Centimeter) | 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. | Analysis includes all evaluable participants. | Posted | | Median | Full Range | cubic centimeter | | Baseline biopsy to prostatectomy following maximum 6 week treatment period | | | | ID | Title | Description |
|---|
| OG000 | Arm I (Finasteride) | Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy. | | OG001 | Arm II (Placebo) | Placebo once daily for 4-6 weeks, then undergo prostatectomy. |
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| Secondary | Characteristics of Blood Biomarkers: Prostate-specific Antigen (ng/mL) Percentage Change (%) | Characteristics of blood biomarkers using pretreatment and posttreatment values. Prostate-specific antigen (PSA) blood test measuring protein produced by prostate cells. | Analysis includes all evaluable participants. | Posted | | Median | Full Range | percentage of change | | Baseline biopsy to prostatectomy following maximum 6 week treatment period | | | | ID | Title | Description |
|---|
| OG000 | Arm I (Finasteride) | Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy. | | OG001 | Arm II (Placebo) | Placebo once daily for 4-6 weeks, then undergo prostatectomy. |
| |
| Secondary | Characteristics of Blood Biomarkers: Testosterone (ng/dL) Percentage Change | Characteristics of blood biomarkers using pretreatment and posttreatment values. Blood tests used for measuring the amount of testosterone in the blood. | Analysis includes all evaluable participants. | Posted | | Median | Full Range | percentage of change | | Baseline biopsy to prostatectomy following maximum 6 week treatment period | | | | ID | Title | Description |
|---|
| OG000 | Arm I (Finasteride) | Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy. | | OG001 | Arm II (Placebo) | Placebo once daily for 4-6 weeks, then undergo prostatectomy. |
| |
| Secondary | Characteristics of Blood Biomarkers: Dihydrotestosterone (ng/dL) Percentage Change | 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. | Analysis includes all evaluable participants. | Posted | | Median | Full Range | percentage of change | | Baseline biopsy to prostatectomy following maximum 6 week treatment period | | | | ID | Title | Description |
|---|
| OG000 | Arm I (Finasteride) | Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy. | | OG001 | Arm II (Placebo) | Placebo once daily for 4-6 weeks, then undergo prostatectomy. |
| |
| Secondary | Characteristics of Blood Biomarkers: Estrone (ng/dL) Percentage Change | 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. | Analysis includes all evaluable participants. | Posted | | Median | Full Range | percentage of change | | Baseline biopsy to prostatectomy following maximum 6 week treatment period | | | | ID | Title | Description |
|---|
| OG000 | Arm I (Finasteride) | Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy. | | OG001 | Arm II (Placebo) | Placebo once daily for 4-6 weeks, then undergo prostatectomy. |
| |
| Secondary | Characteristics of Blood Biomarkers: Estradiol (ng/dL) Percentage Change | Characteristics of blood biomarkers using pretreatment and posttreatment values. Blood test used to measure Estradiol. | Analysis includes all evaluable participants. | Posted | | Median | Full Range | percentage of change | | Baseline biopsy to prostatectomy following maximum 6 week treatment period | | | | ID | Title | Description |
|---|
| OG000 | Arm I (Finasteride) | Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy. | | OG001 | Arm II (Placebo) | Placebo once daily for 4-6 weeks, then undergo prostatectomy. |
| |
| Primary | Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 3 (GG3) Biomarker Subgroups at Prostatectomy | 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. | 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. | Posted | | Median | Full Range | Percentage tumor cell involvement | | At prostatectomy following maximum 6 week treatment period | | | | ID | Title | Description |
|---|
| OG000 | Finasteride Arm Within GG3 | Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy. | | OG001 | Placebo Arm Within GG3 |
|
| Primary | Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 4 (GG4) Biomarker Subgroup at Prostatectomy | 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. | 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. | Posted | | Median | Full Range | Percentage of tumor cell involvement | | At prostatectomy following maximum 6 week treatment period | | | | ID | Title | Description |
|---|
| OG000 | Finasteride Arm Within GG4 | Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy. | | OG001 | Placebo Arm Within GG4 | |
|
| Primary | Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 3 (GG3) Biomarker Subgroups at Prostatectomy | 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. | 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. | Posted | | Mean | Standard Deviation | Percentage of tumor cell involvement | | At prostatectomy following maximum 6 week treatment period. | | | | ID | Title | Description |
|---|
| OG000 | Finasteride Arm Within GG3 | Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy. | | OG001 | Placebo Arm Within GG3 | |
|
| Primary | Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 4 (GG4) Biomarker Subgroup at Prostatectomy | 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. | 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. | Posted | | Mean | Standard Deviation | Percentage of tumor cell involvement | | At prostatectomy following maximum 6 week treatment period. | | | | ID | Title | Description |
|---|
| OG000 | Finasteride Arm Within GG4 | Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy. | | OG001 | Placebo Arm Within GG4 | |
|
| Secondary | Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Finasteride Treatment Arm for Biomarker Subgroups (Mean) | 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. | 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. | Posted | | Mean | Standard Deviation | Percentage of tumor cell involvement | | At prostatectomy following maximum 6 week treatment period | | | | ID | Title | Description |
|---|
| OG000 | GG3, Within Finasteride Arm | Participants with GG3 score receiving 5 mg daily for 4-6 weeks, then receive prostatectomy. | | OG001 | GG4, Within Finasteride Arm | Participants with GG4 score receiving 5 mg daily for 4-6 weeks, then receive prostatectomy. |
| |
| Secondary | Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Placebo Treatment Arm for Biomarker Subgroups (Mean) | 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. | 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. | Posted | | Mean | Standard Deviation | Percentage of tumor cell involvement | | At prostatectomy following maximum 6 week treatment period. | | | | ID | Title | Description |
|---|
| OG000 | GG3, Within Placebo Arm | Participants with GG3 score in Placebo Arm, receiving placebo daily for 4-6 weeks, then receive prostatectomy. | | OG001 | GG4, Within Placebo Arm | Participants with GG4 score in Plaebo Arm, receiving placebo daily for 4-6 weeks, then receive prostatectomy. |
| |
| Secondary | Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Finasteride Treatment Arm for Biomarker Subgroups | 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. | 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. | Posted | | Median | Full Range | Percentage of tumor cell involvement | | At prostatectomy following maximum 6 week treatment period | | | | ID | Title | Description |
|---|
| OG000 | Within GG3, Finasteride Arm | Participants with GG3 score in Finasteride Arm, receiving 5 mg daily for 4-6 weeks, then receive prostatectomy. | | OG001 | Within GG4, Finasteride Arm | Participants with GG4 score in Finasteride Arm, receiving 5 mg daily for 4-6 weeks, then receive prostatectomy. |
| |
| Secondary | Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Within Placebo Treatment Arm for Biomarker Subgroups | 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. | 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. | Posted | | Median | Full Range | Percentage of tumor cell involvement | | At prostatectomy following maximum 6 week treatment period. | | | | ID | Title | Description |
|---|
| OG000 | Within GG3, Placebo Arm | Participants with GG3 score in Placebo Arm, receiving placebo daily for 4-6 weeks, then receive prostatectomy. | | OG001 | Within GG4, Placebo Arm | Participants with GG4 score in Plaebo Arm, receiving placebo daily for 4-6 weeks, then receive prostatectomy. |
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