Trial · NCT00438464
Finasteride in Treating Patients With Stage II Prostate Cancer Who Are Undergoing Surgery
NCT00438464, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2016-03-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Finasteride in Treating Patients With Stage II Prostate Cancer Who Are Undergoing Surgery. Trials, record NCT00438464. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00438464
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Finasteride in Treating Patients With Stage II Prostate Cancer Who Are Undergoing Surgery
- NCT number
- NCT00438464
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 204 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Adenocarcinoma of the Prostate, Stage II Prostate Cancer
- Interventions
- Finasteride, Placebo, Prostatectomy, Laboratory biomarker analysis
- First posted
- 2007-02-22
- Last updated
- 2016-03-09
- Results first posted
- 2016-03-09
- Limitations and caveats
- Predefined molecular signature could not easily distinguish GG 4 from GG 3 tumor areas in the placebo arm.
Source ClinicalTrials.gov
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 3 (GG3) Biomarker Subgroups at Prostatectomy | At prostatectomy following maximum 6 week treatment period | 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. |
| Primary | Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 4 (GG4) Biomarker Subgroup at Prostatectomy | At prostatectomy following maximum 6 week treatment period | 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. |
| Primary | Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 3 (GG3) Biomarker Subgroups at Prostatectomy | At prostatectomy following maximum 6 week treatment period. | Molecular marker expression compared between tumor foci using Biomarkers pretreatment and posttreatment values. Staining microarrays for high-throughput assessment of candidate gene expression and data modeling constructed with a tissue microarray apparatus and 0.6-mm biopsy cores, representative of tumor grades and scores (Gleason Grades 3 (GG3) and Gleason Grade 4 (GG4)). The percentage of tumor cells exhibiting detectable staining, scored as 0 to 10 where higher score designates more involvement, as applicable for: VEGF denotes vascular epithelial growth factor, ERβ estrogen receptor beta, AR androgen receptor, SRD5A2, 3-oxo-5α-steroid 4-dehydrogenase 2, UBE2C, ubiquitin-conjugating enzyme E2C. |
| Primary | Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 4 (GG4) Biomarker Subgroup at Prostatectomy | At prostatectomy following maximum 6 week treatment period. | Molecular marker expression compared between tumor foci using biomarkers pretreatment and posttreatment values. Staining microarrays for high-throughput assessment of candidate gene expression and data modeling constructed with a tissue microarray apparatus and 0.6-mm biopsy cores, representative of tumor grades and scores (Gleason Grades 3 (GG3) and Gleason Grade 4 (GG4)). The percentage of tumor cells exhibiting detectable staining, scored as 0 to 10 where higher score designates more involvement, as applicable for: VEGF denotes vascular epithelial growth factor, ERβ estrogen receptor beta, AR androgen receptor, SRD5A2, 3-oxo-5α-steroid 4-dehydrogenase 2, UBE2C, ubiquitin-conjugating enzyme E2C. |
| Secondary | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Score | Assessment following maximum 6 week treatment period and prostatectomy | 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. |
| Secondary | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Grade -- Specimen (Primary) | Assessment following maximum 6 week treatment period and prostatectomy | 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. |
| Secondary | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Grade -- Specimen (Secondary) | Assessment following maximum 6 week treatment period and prostatectomy | 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. |
| Secondary | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Tumor, Node, Metastasis (TNM) Stage | Assessment following maximum 6 week treatment period and prostatectomy | 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. |
| Secondary | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Margin of Resection (MOR) | Assessment following maximum 6 week treatment period and prostatectomy | 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. |
| Secondary | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Lymph Node Status | Assessment following maximum 6 week treatment period and prostatectomy | 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. |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 registered outcomesOutcomes24
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Score | Assessment following maximum 6 week treatment period and 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. | participants | NUMBER |
| SECONDARY | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Grade -- Specimen (Primary) | Assessment following maximum 6 week treatment period and 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. | participants | NUMBER |
| SECONDARY | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Grade -- Specimen (Secondary) | Assessment following maximum 6 week treatment period and 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. | participants | NUMBER |
| SECONDARY | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Tumor, Node, Metastasis (TNM) Stage | Assessment following maximum 6 week treatment period and prostatectomy | All evaluable participants. | participants | NUMBER |
| SECONDARY | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Margin of Resection (MOR) | Assessment following maximum 6 week treatment period and prostatectomy | Analysis includes all evaluable participants. | participants | NUMBER |
| SECONDARY | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Lymph Node Status | Assessment following maximum 6 week treatment period and prostatectomy | Analysis includes all evaluable participants. | participants | NUMBER |
| SECONDARY | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Cancer Foci | Assessment following maximum 6 week treatment period and prostatectomy | Analysis includes all evaluable participants. | participants | NUMBER |
| SECONDARY | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Zonal Origin of Tumor Foci Per Radical Prostatectomy Specimen (RPS) | Assessment following maximum 6 week treatment period and prostatectomy | Analysis includes all evaluable participants. | participants | NUMBER |
| SECONDARY | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Zonal Origin -- Dominant Tumor Focus | Assessment following maximum 6 week treatment period and prostatectomy | Analysis includes all evaluable participants. | participants | NUMBER |
| SECONDARY | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Upgrade Between Biopsy and Prostatectomy | Baseline biopsy to prostatectomy following maximum 6 week treatment period | Analysis includes all evaluable participants. | participants | NUMBER |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 outcomesResults by group192
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Score | Arm I (Finasteride) | Gleason Score 6 | 12 | participants | |
| Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Score | Arm II (Placebo) | Gleason Score 6 | 10 | participants | |
| Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Score | Arm I (Finasteride) | Gleason Score 7 | 71 | participants | |
| Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Score | Arm II (Placebo) | Gleason Score 7 | 78 | participants | |
| Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Score | Arm I (Finasteride) | Gleason Score 8 | 2 | participants | |
| Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Score | Arm II (Placebo) | Gleason Score 8 | 1 | participants | |
| Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Score | Arm I (Finasteride) | Gleason Score 9 | 3 | participants | |
| Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Score | Arm II (Placebo) | Gleason Score 9 | 4 | participants | |
| Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Grade -- Specimen (Primary) | Arm I (Finasteride) | Grade 3 | 65 | participants | |
| Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Grade -- Specimen (Primary) | Arm II (Placebo) | Grade 3 | 75 | participants |
1 to 10 of 192Source ClinicalTrials.gov
See all 192 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm I (Finasteride) | 103 | |
| Overall Study | STARTED | Arm II (Placebo) | 101 | |
| Overall Study | Received Assigned Intervention | Arm I (Finasteride) | 89 | |
| Overall Study | Received Assigned Intervention | Arm II (Placebo) | 94 | |
| Overall Study | COMPLETED | Arm I (Finasteride) | 89 | |
| Overall Study | COMPLETED | Arm II (Placebo) | 94 | |
| Overall Study | NOT COMPLETED | Arm I (Finasteride) | 14 | |
| Overall Study | NOT COMPLETED | Arm II (Placebo) | 7 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I (Finasteride) | ||
| Total, all-cause mortality | Arm II (Placebo) | ||
| Total, other adverse events | Arm I (Finasteride) | 0 | 89 |
| Total, other adverse events | Arm II (Placebo) | 0 | 94 |
| Total, serious adverse events | Arm I (Finasteride) | 0 | 89 |
| Total, serious adverse events | Arm II (Placebo) | 0 | 94 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants2
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| P30CA016672 | The University of Texas MD Anderson Cancer Center Support Grant (CCSG) | KOONG, ALBERT | UNIVERSITY OF TX MD ANDERSON CAN CTR | NATIONAL CANCER INSTITUTE | 1985 to 2026 | NIH RePORTER |
| N01CN035159 | PHASE I and II CLINICAL TRIALS OF CHEMOPREVENTIVE AGENTS-261035159-261035159 | LIPPMAN, SCOTT M. | UNIVERSITY OF TEXAS M D ANDER | DIVISION OF CANCER PREVENTION AND CONTROL | 2004 to 2006 | NIH RePORTER |
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Arm I (Finasteride) vs Arm II (Placebo): serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
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GET https://conductscience.org/api/trials/v1/NCT00438464/registered?page=2