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| ID | Type | Description | Link |
|---|---|---|---|
| RPCI I 104607 | Other Identifier | Roswell Park Cancer Institute |
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RATIONALE: Selenomethionine may slow the growth of prostate cancer. Testosterone can cause the growth of prostate cancer cells. Finasteride may fight prostate cancer by lowering the amount of testosterone the body makes. Giving selenomethionine together with finasteride before surgery or radiation therapy may be an effective treatment for prostate cancer.
PURPOSE: This randomized phase II trial is studying how well selenomethionine and finasteride work when given before surgery or radiation therapy in treating patients with stage I or stage II prostate cancer.
OBJECTIVES:
Primary
Secondary
Tertiary
OUTLINE: Patients are randomized to 1 of 4 treatment arms.
Blood samples are collected at baseline and on the day of prostatectomy or brachytherapy. Samples are analyzed for testosterone and 5-α-dihydrotestosterone levels by capillary gas chromatography-mass spectrometry; genetic polymorphisms in the type 2 5-α reductase gene by PCR and sequencing analyses; and selenium levels by atomic absorption spectrophotometry. Additional blood samples will be stored for future analysis of alpha and gamma tocopherol, lycopene, and other vitamin levels. Toenail samples are also collected to provide an indicator of long-term selenium status. Prostate tissue samples are collected during and after prostatectomy or prior to brachytherapy. Samples are analyzed for expression of biomarkers (e.g., prostate-specific antigen, kallikrein 2, and NKX 3.1) by quantitative RT-PCR and apoptosis by TUNEL assay, immunohistochemistry, and ELISA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | Experimental | Patients receive oral selenomethionine and oral finasteride once daily for 4-5 weeks. |
|
| Arm II | Experimental | Patients receive oral placebo and oral finasteride once daily for 4-5 weeks. |
|
| Arm III | Experimental | Patients receive oral selenomethionine and oral placebo once daily for 4-5 weeks. |
|
| Arm IV | Placebo Comparator | Patients receive two oral placebos once daily for 4-5 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| selenomethionine | Dietary Supplement | Given orally |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Effects of Selenium and Finasteride and Their Combination on PSA Level | Compare PSA levels with Finasteride Placebo + Selenium Placebo group (Arm C). The Wilcoxon Rank Sum Test was used to test the difference of PSA levels of Arm A, Arm B, Arm D with Arm C. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Effects of Selenium and Finasteride and Their Combination on Apoptosis Induction | Compare cleaved caspase 3 values with Finasteride Placebo + Selenium Placebo group (Arm C). The Wilcoxon Rank Sum Test was used to test the difference of cleaved caspase 3 values of Arm A, Arm B, Arm D with Arm C. | 1 year |
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DISEASE CHARACTERISTICS:
Histologically proven adenocarcinoma of the prostate
Prostate-specific antigen < 20.0 ng/mL
Gleason score < 8
Scheduled to undergo prostatectomy or brachytherapy
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
More than 1 year since prior finasteride, dutasteride, Sereona repens (saw palmetto), or any other 5-α reductase inhibitor
No prior hormonal therapy or radiotherapy
More than 30 days since prior and no concurrent participation in any other clinical trial involving a medical, surgical, nutritional, or life-style intervention (e.g., dietary modification or exercise)
No concurrent selenium dietary supplement at doses > 200 mg/day, including multivitamin supplements
No other concurrent hormonal therapy, including 5-α reductase inhibitors (e.g., finasteride or dutasteride); anti-androgens (e.g., bicalutamide, flutamide, or ketoconazole); or luteinizing hormone-releasing hormone agonists (e.g., leuprolide acetate, goserelin acetate, or abarelix)
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| Name | Affiliation | Role |
|---|---|---|
| James L. Mohler, MD | Roswell Park Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Cancer Institute | Buffalo | New York | 14263-0001 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A: Finasteride + Selenium Placebo | Patients receive oral placebo and oral finasteride once daily for 4-5 weeks. Finasteride: Given orally Placebo: Given orally |
| FG001 | Arm B: Finasteride + Selenium | Patients receive oral selenomethionine and oral finasteride once daily for 4-5 weeks. Selenomethionine: Given orally Finasteride: Given orally |
| FG002 | Arm C: Finasteride Placebo + Selenium Placebo | Patients receive two oral placebos once daily for 4-5 weeks. Placebo: Given orally |
| FG003 | Arm D: Finasteride Placebo + Selenium | Patients receive oral selenomethionine and oral placebo once daily for 4-5 weeks. Selenomethionine: Given orally Placebo: Given orally |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All treated and eligible patients
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A: Finasteride + Selenium Placebo | Patients receive oral placebo and oral finasteride once daily for 4-5 weeks. Finasteride: Given orally Placebo: Given orally |
| BG001 | Arm B: Finasteride + Selenium |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Effects of Selenium and Finasteride and Their Combination on PSA Level | Compare PSA levels with Finasteride Placebo + Selenium Placebo group (Arm C). The Wilcoxon Rank Sum Test was used to test the difference of PSA levels of Arm A, Arm B, Arm D with Arm C. | All treated and eligible patients | Posted | Median | Full Range | ng/mL | 1 year |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm A: Finasteride + Selenium Placebo | Patients receive oral placebo and oral finasteride once daily for 4-5 weeks. Finasteride: Given orally Placebo: Given orally |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac valve disease | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Administrator, Compliance - Clinical Research Services | Roswell Park Cancer Institute | 716-845-2300 | Adrienne.Groman@RoswellPark.org |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D012645 | Selenomethionine |
| D018120 | Finasteride |
| ID | Term |
|---|---|
| D016566 | Organoselenium Compounds |
| D009930 | Organic Chemicals |
| D008715 | Methionine |
| D000603 | Amino Acids, Sulfur |
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| finasteride |
| Drug |
Given orally |
|
| placebo | Other | Given orally |
|
Patients receive oral selenomethionine and oral finasteride once daily for 4-5 weeks.
Selenomethionine: Given orally
Finasteride: Given orally
| BG002 | Arm C: Finasteride Placebo + Selenium Placebo | Patients receive two oral placebos once daily for 4-5 weeks. Placebo: Given orally |
| BG003 | Arm D: Finasteride Placebo + Selenium | Patients receive oral selenomethionine and oral placebo once daily for 4-5 weeks. Selenomethionine: Given orally Placebo: Given orally |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG002 | Arm C: Finasteride Placebo + Selenium Placebo | Patients receive two oral placebos once daily for 4-5 weeks. Placebo: Given orally |
| OG003 | Arm D: Finasteride Placebo + Selenium | Patients receive oral selenomethionine and oral placebo once daily for 4-5 weeks. Selenomethionine: Given orally Placebo: Given orally |
|
|
|
| Secondary | Effects of Selenium and Finasteride and Their Combination on Apoptosis Induction | Compare cleaved caspase 3 values with Finasteride Placebo + Selenium Placebo group (Arm C). The Wilcoxon Rank Sum Test was used to test the difference of cleaved caspase 3 values of Arm A, Arm B, Arm D with Arm C. | All treated and eligible patients | Posted | Median | Full Range | percentage of apoptotic cells | 1 year |
|
|
|
|
| 0 |
| 13 |
| 2 |
| 13 |
| EG001 | Arm B: Finasteride + Selenium | Patients receive oral selenomethionine and oral finasteride once daily for 4-5 weeks. Selenomethionine: Given orally Finasteride: Given orally | 2 | 15 | 3 | 15 |
| EG002 | Arm C: Finasteride Placebo + Selenium Placebo | Patients receive two oral placebos once daily for 4-5 weeks. Placebo: Given orally | 1 | 14 | 4 | 14 |
| EG003 | Arm D: Finasteride Placebo + Selenium | Patients receive oral selenomethionine and oral placebo once daily for 4-5 weeks. Selenomethionine: Given orally Placebo: Given orally | 2 | 13 | 3 | 13 |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | Systematic Assessment |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Postoperative ileus | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Urine analysis abnormal | Investigations | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Orchitis | Infections and infestations | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D013457 |
| Sulfur Compounds |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D001378 | Azasteroids |
| D013260 | Steroids, Heterocyclic |
| Other |
| Wilcoxon (Mann-Whitney) | 0.9727 | Other |