A Phase 2 interventional study of Finasteride and Placebo in Adenocarcinoma of the Prostate and Stage II Prostate Cancer, sponsored by National Cancer Institute (NCI). Completed at 8 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-03-09.
Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Treatment
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.
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.
III. Compare GG 3-appearing areas (in tumors rated GS 6 at prostatectomy) in patients treated with finasteride vs placebo.
IV. Compare GG 3-appearing areas (in tumors rated GS 7 at prostatectomy) in patients treated with finasteride vs placebo.
V. Compare GG 4-appearing areas (in tumors rated GS 7 at prostatectomy) in patients treated with finasteride vs placebo.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study.
Patients are stratified according to study site, Gleason score (6 vs 7), and type of prostatectomy (open vs robotic/laparoscopic). Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients receive finasteride orally (PO) once daily (QD) for 4-6 weeks, and then undergo prostatectomy.
Arm II: Patients receive placebo PO QD for 4-6 weeks, and then undergo prostatectomy.
Tumor tissue obtained at prostatectomy is used to make tissue microarrays and is analyzed by immunohistochemistry for molecular marker expression studies.
After completion of study treatment, patients are followed up for 30 days.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,397 are open to participants now.
This study's enrollment of 204 is above the median of 58 across 4,821 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.
Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.
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Criteria:
Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
Drug: Finasteride · Procedure: Prostatectomy · Other: Laboratory biomarker analysis
Placebo once daily for 4-6 weeks, then undergo prostatectomy.
Other: Placebo · Other: Laboratory biomarker analysis
Given PO
Also known as: Finastid, MK 906, Proscar, Prostide
Given PO
Also known as: PLCB
Undergo prostatectomy
Also known as: Radical Prostatectomy, Therapeutic conventional surgery, Simple Prostatectomy
Correlative studies
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.
Time frame: At prostatectomy following maximum 6 week treatment period
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.
Time frame: At prostatectomy following maximum 6 week treatment period
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.
Time frame: At prostatectomy following maximum 6 week treatment period.
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.
Time frame: At prostatectomy following maximum 6 week treatment period.
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.
Time frame: Assessment following maximum 6 week treatment period and prostatectomy
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.
Time frame: Assessment following maximum 6 week treatment period and prostatectomy
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.
Time frame: Assessment following maximum 6 week treatment period and prostatectomy
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.
Time frame: Assessment following maximum 6 week treatment period and prostatectomy
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.
Time frame: Assessment following maximum 6 week treatment period and prostatectomy
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.
Time frame: Assessment following maximum 6 week treatment period and prostatectomy
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.
Time frame: Assessment following maximum 6 week treatment period and prostatectomy
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.
Time frame: Assessment following maximum 6 week treatment period and prostatectomy
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.
Time frame: Assessment following maximum 6 week treatment period and prostatectomy
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.
Time frame: Baseline biopsy to prostatectomy following maximum 6 week treatment period
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.
Time frame: Baseline biopsy to prostatectomy following maximum 6 week treatment period
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.
Time frame: Baseline biopsy to prostatectomy following maximum 6 week treatment period
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.
Time frame: Baseline biopsy to prostatectomy following maximum 6 week treatment period
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.
Time frame: Baseline biopsy to prostatectomy following maximum 6 week treatment period
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.
Time frame: Baseline biopsy to prostatectomy following maximum 6 week treatment period
Characteristics of Blood Biomarkers: Estradiol (ng/dL) Percentage Change
Characteristics of blood biomarkers using pretreatment and posttreatment values. Blood test used to measure Estradiol.
Time frame: 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 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.
Time frame: At 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)
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: At prostatectomy following maximum 6 week treatment period.
Recruitment period: From 2007 to 2012 recruitment was done at various medical clinic locations.
| Milestone | Arm I (Finasteride) | Arm II (Placebo) |
|---|---|---|
| Started | 103 | 101 |
| Received assigned intervention | 89 | 94 |
| Completed | 89 | 94 |
| Not completed | 14 | 7 |
| Withdrew: Terminated early | 14 | 5 |
| Withdrew: Incomplete data submission | 0 | 2 |
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.
| participants | Arm I (Finasteride) | Arm II (Placebo) |
|---|---|---|
| Gleason Score 6 | 12 | 10 |
| Gleason Score 7 | 71 | 78 |
| Gleason Score 8 | 2 | 1 |
| Gleason Score 9 | 3 | 4 |
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.
| participants | Arm I (Finasteride) | Arm II (Placebo) |
|---|---|---|
| Grade 3 | 65 | 75 |
| Grade 4 | 23 | 18 |
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.
| participants | Arm I (Finasteride) | Arm II (Placebo) |
|---|---|---|
| Grade 3 | 31 | 24 |
| Grade 4 | 53 | 64 |
| Grade 5 | 4 | 5 |
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.
| participants | Arm I (Finasteride) | Arm II (Placebo) |
|---|---|---|
| pT2 | 73 | 74 |
| pT3a | 11 | 15 |
| pT3b | 5 | 5 |
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.
| participants | Arm I (Finasteride) | Arm II (Placebo) |
|---|---|---|
| Positive | 17 | 16 |
| Negative | 67 | 76 |
| Equivocal | 5 | 2 |
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.
| participants | Arm I (Finasteride) | Arm II (Placebo) |
|---|---|---|
| PN0 | 46 | 43 |
| PN1 | 2 | 2 |
| pNX | 41 | 49 |
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.
| participants | Arm I (Finasteride) | Arm II (Placebo) |
|---|---|---|
| 1 Focus | 15 | 11 |
| 2 Foci | 18 | 20 |
| 3 Foci | 28 | 28 |
| 4 Foci | 13 | 20 |
| >/= 5 Foci | 15 | 15 |
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.
| participants | Arm I (Finasteride) | Arm II (Placebo) |
|---|---|---|
| PZ | 35 | 38 |
| PZ + TZ | 49 | 50 |
| PZ + TZ + CZ | 2 | 2 |
| PZ + CZ | 0 | 1 |
| TZ | 3 | 3 |
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.
| participants | Arm I (Finasteride) | Arm II (Placebo) |
|---|---|---|
| PZ | 67 | 73 |
| TZ | 22 | 21 |
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.
| participants | Arm I (Finasteride) | Arm II (Placebo) |
|---|---|---|
| No | 63 | 70 |
| Yes | 26 | 24 |
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.
| cubic centimeter | Arm I (Finasteride) | Arm II (Placebo) |
|---|---|---|
| Total | 1.0 (0.0 to 9.3) | 0.8 (0.0 to 10.4) |
| PZ Cancer focus/foci | 0.6 (0.0 to 9.3) | 0.5 (0.0 to 9.0) |
| TZ cancer focus/foci | 0.0 (0.0 to 6.0) | 0.0 (0.0 to 10.4) |
Characteristics of blood biomarkers using pretreatment and posttreatment values. Prostate-specific antigen (PSA) blood test measuring protein produced by prostate cells.
| percentage of change | Arm I (Finasteride) | Arm II (Placebo) |
|---|---|---|
| Characteristics of Blood Biomarkers: Prostate-specific Antigen (ng/mL) Percentage Change (%) | -39.4 (-96.6 to 155.2) | -4.6 (-61.2 to 200.0) |
Characteristics of blood biomarkers using pretreatment and posttreatment values. Blood tests used for measuring the amount of testosterone in the blood.
| percentage of change | Arm I (Finasteride) | Arm II (Placebo) |
|---|---|---|
| Characteristics of Blood Biomarkers: Testosterone (ng/dL) Percentage Change | 13 (-53 to 158) | -4.6 (-80.7 to 76.1) |
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.
| percentage of change | Arm I (Finasteride) | Arm II (Placebo) |
|---|---|---|
| Characteristics of Blood Biomarkers: Dihydrotestosterone (ng/dL) Percentage Change | -64.8 (-90 to 120) | -3.6 (-64.7 to 615.1) |
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.
| percentage of change | Arm I (Finasteride) | Arm II (Placebo) |
|---|---|---|
| Characteristics of Blood Biomarkers: Estrone (ng/dL) Percentage Change | -8.9 (-93.2 to 870) | 0 (-81.8 to 760) |
Characteristics of blood biomarkers using pretreatment and posttreatment values. Blood test used to measure Estradiol.
| percentage of change | Arm I (Finasteride) | Arm II (Placebo) |
|---|---|---|
| Characteristics of Blood Biomarkers: Estradiol (ng/dL) Percentage Change | 7.2 (-80.0 to 700) | 0 (-86.8 to 161.5) |
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.
| Percentage tumor cell involvement | Finasteride Arm Within GG3 | Placebo Arm Within GG3 |
|---|---|---|
| VEGF (N=37,55) | 80 (5 to 100) | 90 (0 to 100) |
| ERβ (N=35, 55) | 15.0 (0.03 to 59.0) | 6.6 (0 to 56.3) |
| AR (N=35, 54) | 75.2 (21.5 to 92.1) | 78.3 (33.8 to 97.6) |
| Ki-67 (N=37,54) | 1.1 (0.05 to 5.4) | 1.3 (0.03 to 4.5) |
| SRD5A2 (N=45,47) | 100 (0 to 100) | 90 (0 to 100) |
| UBE2C (N=34,55) | 0.4 (0 to 1.5) | 0.3 (0 to 2.4) |
| Caspase (N=38,55) | 0.2 (0.01 to 4.1) | 0.08 (0 to 0.8) |
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.
| Percentage of tumor cell involvement | Finasteride Arm Within GG4 | Placebo Arm Within GG4 |
|---|---|---|
| VEGF (N=48,61) | 85 (5 to 100) | 70 (0 to 100) |
| ERβ (N=48,62) | 8.0 (0 to 49.6) | 9.5 (0 to 72.8) |
| AR (N=48,62) | 63.71 (13.5 to 92.0) | 75.9 (1.4 to 96.6) |
| Ki-67 (N=48,62) | 1.3 (0.05 to 7.2) | 1.4 (0.05 to 7.3) |
| SRD5A2 (N=38,69) | 95 (0 to 100) | 90 (0 to 100) |
| UBE2C (N=46,62) | 0.3 (0 to 1.6) | 0.3 (0 to 2.3) |
| Caspase (N=47,61) | 0.06 (0 to 0.5) | 0.04 (0 to 0.6) |
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.
| Percentage of tumor cell involvement | Finasteride Arm Within GG3 | Placebo Arm Within GG3 |
|---|---|---|
| VEGF (N=37,55) | 63.9 ± 36.3 | 63.7 ± 38 |
| ERβ (N=35, 55) | 18.1 ± 15.6 | 14.8 ± 14.7 |
| AR (N=35, 54) | 69.8 ± 17.3 | 72.4 ± 16.7 |
| Ki-67 (N=37,54) | 1.6 ± 1.4 | 1.5 ± 1.0 |
| SRD5A2 (N=45,47) | 72.9 ± 37.0 | 64.7 ± 43.7 |
| UBE2C (N=34,55) | 0.5 ± 0.4 | 0.5 ± 0.5 |
| Caspase (N=38,55) | 0.4 ± 0.7 | 0.2 ± 0.2 |
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.
| Percentage of tumor cell involvement | Finasteride Arm Within GG4 | Placebo Arm Within GG4 |
|---|---|---|
| VEGF (N=48,61) | 63.6 ± 35.5 | 59.8 ± 35.4 |
| ERβ (N=48,62) | 15.0 ± 15.1 | 16.7 ± 18.8 |
| AR (N=48,62) | 64.3 ± 16.67 | 68.6 ± 23.1 |
| Ki-67 (N=48,62) | 1.8 ± 1.6 | 1.7 ± 1.4 |
| SRD5A2 (N=38,69) | 71.8 ± 37.6 | 64.9 ± 40.8 |
| UBE2C (N=46,62) | 0.5 ± 0.4 | 0.5 ± 0.4 |
| Caspase (N=47,61) | 0.1 ± 0.1 | 0.06 ± 0.08 |
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.
| Percentage of tumor cell involvement | GG3, Within Finasteride Arm | GG4, Within Finasteride Arm |
|---|---|---|
| VEGF (N=37,48) | 63.9 ± 36.3 | 63.7 ± 35.5 |
| ERβ (N=35,48) | 18.1 ± 15.6 | 15.0 ± 15.1 |
| AR (N=35,48) | 69.8 ± 17.3 | 64.3 ± 16.7 |
| Ki-67 (N=37,48) | 1.6 ± 1.4 | 1.8 ± 1.6 |
| SRD5A2 (N=45,38) | 72.9 ± 37.0 | 71.8 ± 37.6 |
| UBE2C (N=34,46) | 0.5 ± 0.4 | 0.5 ± 0.4 |
| Caspase (N=38,47) | 0.4 ± 0.7 | 0.1 ± 0.1 |
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.
| Percentage of tumor cell involvement | GG3, Within Placebo Arm | GG4, Within Placebo Arm |
|---|---|---|
| VEGF (N=55,61) | 63.7 ± 38 | 59.7 ± 35.4 |
| ERβ (N=55,62) | 14.8 ± 14.7 | 16.7 ± 18.8 |
| AR (N=54,62) | 72.4 ± 16.7 | 68.6 ± 23.1 |
| Ki-67 (N=54,62) | 1.5 ± 1.0 | 1.7 ± 1.4 |
| SRD5A2 (N=47,69) | 64.7 ± 43.7 | 64.9 ± 40.8 |
| UBE2C (N=55,62) | 0.5 ± 0.5 | 0.5 ± 0.4 |
| Caspase (N=55,61) | 0.2 ± 0.2 | 0.06 ± 0.08 |
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.
| Percentage of tumor cell involvement | Within GG3, Finasteride Arm | Within GG4, Finasteride Arm |
|---|---|---|
| VEGF (N=37,48) | 80 (5 to 100) | 85 (5 to 100) |
| ERβ (N=35,48) | 15.0 (0.03 to 58.9) | 8.0 (0 to 49.56) |
| AR (N=35,48) | 75.2 (21.5 to 92.1) | 63.7 (13.5 to 92.0) |
| Ki-67 (N=37,48) | 1.1 (0.05 to 5.4) | 1.3 (0.05 to 7.2) |
| SRD5A2 (N=45,38) | 100 (0 to 100) | 95 (0 to 100) |
| UBE2C (N=34,46) | 0.4 (0 to 1.5) | 0.3 (0 to 1.6) |
| Caspase (N=38,47) | 0.2 (0.01 to 4.1) | 0.06 (0 to 0.5) |
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.
| Percentage of tumor cell involvement | Within GG3, Placebo Arm | Within GG4, Placebo Arm |
|---|---|---|
| VEGF (N=55,61) | 90 (0 to 100) | 70 (0 to 100) |
| ERβ (N=55,62) | 6.6 (0 to 56.3) | 9.5 (0 to 72.8) |
| AR (N=54,62) | 78.3 (33.77 to 97.6) | 75.9 (1.39 to 96.6) |
| Ki-67 (N=54,62) | 1.3 (0.03 to 4.5) | 1.4 (0.05 to 7.3) |
| SRD5A2 (N=47,69) | 90 (0 to 100) | 90 (0 to 100) |
| UBE2C (N=55,62) | 0.3 (0 to 2.4) | 0.3 (0 to 2.3) |
| Caspase (N=55,61) | 0.08 (0 to 0.8) | 0.04 (0 to 0.6) |
Collected over The final collection of adverse events obtained at the completion of the 4-6 week course of study medication/placebo, before prostatectomy. Overall study period: March 2007 to April 2012.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm I (Finasteride) | — | 0/89 (0%) | 0/89 (0%) |
| Arm II (Placebo) | — | 0/94 (0%) | 0/94 (0%) |
Baseline includes participants who were randomized to arms and received assigned treatment.
| Age, Continuous(years) | Arm I (Finasteride) | Arm II (Placebo) | Total |
|---|---|---|---|
| Median | 59 (45 to 73) | 62 (48 to 73) | 60 (45 to 73) |
| Sex: Female, Male(Participants) | Arm I (Finasteride) | Arm II (Placebo) | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 89 | 94 | 183 |
| Race/Ethnicity, Customized(participants) | Arm I (Finasteride) | Arm II (Placebo) | Total |
|---|---|---|---|
| Asian | 1 | 0 | 1 |
| Black | 5 | 7 | 12 |
| Hispanic | 5 | 2 | 7 |
| White | 78 | 85 | 163 |
| Region of Enrollment(participants) | Arm I (Finasteride) | Arm II (Placebo) | Total |
|---|---|---|---|
| United States | 89 | 94 | 183 |
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