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Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

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Genital Diseases, Male

Urogenital Diseases

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Male Urogenital Diseases

Quality of Life

All Drugs and Chemicals

Antineoplastic Agents

Urological Agents

Androgens

Hormones

Bicalutamide

Finasteride

Dutasteride

Androgen Antagonists

Hormone Antagonists

5-alpha Reductase Inhibitors

Enzyme Inhibitors

Subjects will receive two oral hormonal drugs (bicalutamide with dutasteride or bicalutamide with finasteride)

Bicalutamide 50 mg orally daily with either dutasteride or finasteride for 2 months. After two months of treatment bicalutamide with either dutasteride or finasteride will be taken along with radiation. After completion of radiation, bicalutamide will be stopped.

Dutasteride 0.5 mg orally will be taken daily with bicalutamide for 2 months. After two months of treatment dutasteride and bicalutamide will be taken along with radiation. After completion of radiation, dutasteride will be taken alone for two years.

Finasteride 5 mg orally will be taken daily with bicalutamide for 2 months. After two months of treatment finasteride and bicalutamide will be taken along with radiation. After completion of radiation, finasteride will be taken alone for two years.

7-8 weeks of radiation with bicalutamide and either dutasteride or finasteride.

Radiation

Stanley Liauw, MD

The purpose of this study is see if quality of life is improved in patients receiving oral hormone therapy compared to standard of care. The study will also compare survival rates between patients receiving oral hormone therapy and those receiving standard of care.

Feasibility of Hormones and Radiation for Intermediate or High Risk Prostate Cancer

A Feasibility Study of Oral Hormonal Therapy and Radiation for Non-metastatic, Intermediate or High Risk Prostate Cancer in Men 70 and Older or With Medical Comorbidities

Questionnaires were completed in writing by the patient. Questionnaires were administered at 1-2 months after initiation of hormonal treatment (before RT), at 3-4 months (during RT), and at 6 months after initiation of study therapy. Patients also completed questionnaires at 12, 18, and 24 months after completion of radiation therapy. Of primary interest were the baseline and 6 month and 24 month timepoints which are reported here.

Scale scores could range from 0-100, with higher scores indicating better quality of life.

Increase in prostate-specific antigen (PSA) measured over time. Freedom from biochemical failure (FFBF) was defined from the time of enrollment until PSA failure occurs as defined by the Phoenix definition of a rise to 2 ng/mL above the nadir PSA value.

University of Chicago

the standard of care GnRH agonist (SOC) included bicalutamide 50 mg daily with injectable LHRH agonist (e.g. leuprolide or goserelin). for total duration of 2 years and 4 months Bicalutamide given for 4 months RT given 6-8 weeks

SOC Cohort

Combined androgen blockade in the oral ADT group was bicalutamide 50 mg daily with an oral 5-AR inhibitor (i.e. finasteride 5 mg, or dutasteride 0.5 mg daily), fo rtotal duration of 2 year sand 4 months Bicalutamide given for 4 months RT given 6 8 weeks

Oral ADT Group

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

African American

White

Asian

Hispanic

Race/Ethnicity, Customized

United States

Region of Enrollment

Prostate-Specific Antigen (PSA)

The Adult Comorbidity Evaluation 27 (ACE-27) is a validated comorbidity instrument that provides a score (0-3; 1=mild, 2=moderate, 3=severe) based on the number and severity of medical comorbidities.

Adult Comorbidity Evaluation

Dr. Stanley Liauw

Baseline

6 month

24 month

the standard of care GnRH agonist (SOC) included bicalutamide 50 mg daily with injectable LHRH agonist (e.g. leuprolide or goserelin). for total duration of 2 years and 4 months RT given 6-8 weeks

Combined androgen blockade in the oral ADT group was bicalutamide 50 mg daily with an oral 5-AR inhibitor (i.e. finasteride 5 mg, or dutasteride 0.5 mg daily), fo rtotal duration of 2 year sand 4 months RT given 6 8 weeks

Quality of Life Was Measured by the Expanded Prostate Cancer Index Composite (EPIC) Hormonal Health-related Quality of Life Questionnaire

Percentage of Participants Free From Biochemical Failure

Overall Study

Adenocarcinoma

Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.

Placebo once daily for 4-6 weeks, then undergo prostatectomy.

Placebo

Prostatectomy

Laboratory biomarker analysis

Jeri Kim

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.

Finasteride in Treating Patients With Stage II Prostate Cancer Who Are Undergoing Surgery

A Randomized Controlled Trial Evaluating the Tissue Effects of Preoperative Finasteride Versus Placebo for Patients With Clinically Organ-Confined Prostate Cancer

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Characteristics of blood biomarkers using pretreatment and posttreatment values. Prostate-specific antigen (PSA) blood test measuring protein produced by prostate cells.

Characteristics of blood biomarkers using pretreatment and posttreatment values. Blood tests used for measuring the amount of testosterone in the blood.

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.

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.

Characteristics of blood biomarkers using pretreatment and posttreatment values. Blood test used to measure Estradiol.

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.

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.

M.D. Anderson Cancer Center

National Cancer Institute (NCI)

Arm I (Finasteride)

Arm II (Placebo)

Black

Baseline includes participants who were randomized to arms and received assigned treatment.

Predefined molecular signature could not easily distinguish GG 4 from GG 3 tumor areas in the placebo arm.

Jeri Kim, MD / Associate Professor, Genitourinary Medical Oncology

Gleason Score 6

Gleason Score 7

Gleason Score 8

Gleason Score 9

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.

Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Score

Grade 3

Grade 4

Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Grade -- Specimen (Primary)

Grade 5

Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Grade -- Specimen (Secondary)

pT3a

pT3b

Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Tumor, Node, Metastasis (TNM) Stage

Positive

Negative

Equivocal

Analysis includes all evaluable participants.

Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Margin of Resection (MOR)

Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Lymph Node Status

1 Focus

2 Foci

3 Foci

4 Foci

>/= 5 Foci

Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Cancer Foci

PZ + TZ

PZ + TZ + CZ

PZ + CZ

Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Zonal Origin of Tumor Foci Per Radical Prostatectomy Specimen (RPS)

Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Zonal Origin -- Dominant Tumor Focus

Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Upgrade Between Biopsy and Prostatectomy

PZ Cancer focus/foci

TZ cancer focus/foci

Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Tumor Volume (Cubic Centimeter)

Characteristics of Blood Biomarkers: Prostate-specific Antigen (ng/mL) Percentage Change (%)

Characteristics of Blood Biomarkers: Testosterone (ng/dL) Percentage Change

Characteristics of Blood Biomarkers: Dihydrotestosterone (ng/dL) Percentage Change

Characteristics of Blood Biomarkers: Estrone (ng/dL) Percentage Change

Characteristics of Blood Biomarkers: Estradiol (ng/dL) Percentage Change

Estrogen receptor beta (ERβ), Within GG3

3-oxo-5α-steroid 4-dehydrogenase 2 (SRD5A2), Within GG3

Ubiquitin-conjugating enzyme E2C (UBE2C), Within GG3

VEGF (N=37,55)

ERβ (N=35, 55)

AR (N=35, 54)

Ki-67 (N=37,54)

SRD5A2 (N=45,47)

UBE2C (N=34,55)

Caspase (N=38,55)

Finasteride Arm Within GG3

Placebo Arm Within GG3

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.

Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 3 (GG3) Biomarker Subgroups at Prostatectomy

Vascular Epithelial Growth Factor (VEGF3), Within GG4

Estrogen receptor beta (ERβ), Within GG4

3-oxo-5α-steroid 4-dehydrogenase 2 (SRD5A2), Within GG4

VEGF (N=48,61)

ERβ (N=48,62)

AR (N=48,62)

Ki-67 (N=48,62)

SRD5A2 (N=38,69)

UBE2C (N=46,62)

Caspase (N=47,61)

Finasteride Arm Within GG4

Placebo Arm Within GG4

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=37,48)

ERβ (N=35,48)

AR (N=35,48)

Ki-67 (N=37,48)

SRD5A2 (N=45,38)

UBE2C (N=34,46)

Caspase (N=38,47)

Participants with GG3 score receiving 5 mg daily for 4-6 weeks, then receive prostatectomy.

GG3, Within Finasteride Arm

Participants with GG4 score receiving 5 mg daily for 4-6 weeks, then receive prostatectomy.

GG4, Within Finasteride Arm

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.

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=55,61)

ERβ (N=55,62)

AR (N=54,62)

Ki-67 (N=54,62)

SRD5A2 (N=47,69)

UBE2C (N=55,62)

Caspase (N=55,61)

Participants with GG3 score in Placebo Arm, receiving placebo daily for 4-6 weeks, then receive prostatectomy.

GG3, Within Placebo Arm

Participants with GG4 score in Plaebo Arm, receiving placebo daily for 4-6 weeks, then receive prostatectomy.

GG4, Within Placebo Arm

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.

Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Placebo Treatment Arm for Biomarker Subgroups (Mean)

Participants with GG3 score in Finasteride Arm, receiving 5 mg daily for 4-6 weeks, then receive prostatectomy.

Within GG3, Finasteride Arm

Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Finasteride Treatment Arm for Biomarker Subgroups

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Feasibility of Hormones and Radiation for Intermediate or High Risk Prostate Cancer	NCT01342367	Prostate Cancer	Bicalutamide Dutasteride Finasteride Radiation	18 Years -	University of Chicago
Feasibility of Hormones and Radiation for Intermediate or High Risk Prostate Cancer	NCT01342367	Prostate Cancer	Bicalutamide Dutasteride Finasteride Radiation	18 Years -	University of Chicago
Finasteride in Treating Patients With Stage II Prostate Cancer Who Are Undergoing Surgery	NCT00438464	Adenocarcinoma ... Stage II Prosta...	Finasteride Placebo Prostatectomy Laboratory biom...	18 Years -	National Cancer Institute (NCI)
Selenomethionine and Finasteride Before Surgery or Radiation Therapy in Treating Patients With Stage I or Stage II Prostate Cancer	NCT00736645	Prostate Cancer	selenomethionin... finasteride placebo	18 Years -	Roswell Park Cancer Institute
Hormone Therapy in Treating Patients With Prostate Cancer	NCT00003323	Prostate Cancer Sexual Dysfunct...	finasteride flutamide quality-of-life...	-	Alliance for Clinical Trials in Oncology
3 Month Finasteride Challenge Test Can Significantly Improve the Performance of Screening for Prostate Cancer	NCT01296672	Prostate Cancer	Finasteride Placebo	55 Years -	The University of Texas Health Science Center at San Antonio
Finasteride (MK-0906) and Male Breast Cancer - A Register-Based Nested Case-Control Study (MK-0906-162/2003.021).	NCT01703520	Male Breast Can...		35 Years -	Organon and Co

Spots Global Cancer Trial Database for finasteride

Every month we try and update this database with for finasteride cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for finasteride

Every month we try and update this database with for finasteride cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for finasteride cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.