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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA068485 | U.S. NIH Grant/Contract | View source | |
| CDR0000595004 | |||
| NA_00010227 | Other Identifier | JHM IRB |
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The study was terminated per the PI decision.
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Valproic acid may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether valproic acid is more effective than observation in treating patients with prostate cancer.
PURPOSE: This randomized phase II trial is studying how well valproic acid works in treating patients with progressive, non-metastatic prostate cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 arms.
Patients complete quality of life questionnaires at baseline, 6 months, and 1 year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (standard of care) | Other | Patients undergo observation according to the standard of care. Patients complete quality of life questionnaires at baseline, 6 months, and 1 year. |
|
| Arm II (valproic acid) | Experimental | Patients receive oral valproic acid twice daily for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients complete quality of life questionnaires at baseline, 6 months, and 1 year. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| valproic acid | Drug | given orally |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Exhibiting an Increase in Observed or Predicted Prostate-specific Antigen (PSA) Doubling Time | Number of participants exhibiting an increase in observed or predicted prostate-specific antigen (PSA) doubling time after initiation of the study. Blood was drawn monthly during study period (1 year), serum PSA was measured & PSADT calculated. A doubling time of > 10 month is defined as complete response (3. Secondary Outcome) and this criteria was based on the Pound et al JAMA 1999, Vol 281(No 17) pgs 1591-1697 paper. Any increase in PSADT is defined as partial response (4. Secondary Outcome). | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of PSA Response as Assessed by PSA Doubling Time (PSADT) | Serum PSA was measured once a month, each month for the one year the subjects were on the protocol. PSA Doubling time is defined as the duration for PSA levels in the blood to increase by 100 percent, and is calculated based on the rate of change in serum PSA values. Prostate-specific antigen doubling time (PSADT) was calculated by natural log of 2 (0.693) divided by the slope of the relationship between the log of PSA and time of PSA measurement for each patient (Pound et al JAMA 1999, Vol 281(No 17) pgs 1591-1697), therefore it can be much greater than the 12 months that we followed the patients for. PSADT was calculated for pre enrollment, at the mid point of the study & at the end of study. |
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DISEASE CHARACTERISTICS:
Histologically confirmed prostate cancer
Biochemical progression after definitive local therapy (radical prostatectomy)
PSA doubling time (DT) < 10 months after local therapy (in patients who have not received prior hormone therapy)
No clinical or radiological evidence of metastatic disease, including bone metastasis
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Ronald Rodriguez, MD, PhD | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | 21231-2410 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm I (Standard of Care) | Patients undergo observation according to the standard of care. Patients complete quality of life questionnaires at baseline, 6 months, and 1 year. standard of care follow-up: participant follow the standard of care for patient with metastatic prostate cancer |
| FG001 | Arm II (Valproic Acid) | Patients receive oral valproic acid twice daily for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients complete quality of life questionnaires at baseline, 6 months, and 1 year. valproic acid: given orally |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm I (Standard of Care) | Patients undergo observation according to the standard of care. Patients complete quality of life questionnaires at baseline, 6 months, and 1 year. standard of care follow-up: participant follow the standard of care for patient with metastatic prostate cancer |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Number of Participants Exhibiting an Increase in Observed or Predicted Prostate-specific Antigen (PSA) Doubling Time | Number of participants exhibiting an increase in observed or predicted prostate-specific antigen (PSA) doubling time after initiation of the study. Blood was drawn monthly during study period (1 year), serum PSA was measured & PSADT calculated. A doubling time of > 10 month is defined as complete response (3. Secondary Outcome) and this criteria was based on the Pound et al JAMA 1999, Vol 281(No 17) pgs 1591-1697 paper. Any increase in PSADT is defined as partial response (4. Secondary Outcome). | One participant from Arm 1 was lost to follow-up; One participant from Arm II was lost to follow-up and another withdrew consent | Posted | Count of Participants | Participants | 1 year |
|
One year
AE was self-reported at every study visit and also on-going basis. Participants had access to PI and research nurse at all times during the study.
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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 I (Standard of Care) | Patients undergo observation according to the standard of care. Patients complete quality of life questionnaires at baseline, 6 months, and 1 year. standard of care follow-up: participant follow the standard of care for patient with metastatic prostate cancer |
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The study was designed to have power with 15 patients in each arm. The study was closed before we reached the target as the PI changed institution.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ron Rodriguez, MD, PhD | UTHSCSA | 2105675643 | rodriguezr32@uthscsa.edu |
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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 |
|---|---|
| D014635 | Valproic Acid |
| ID | Term |
|---|---|
| D010421 | Pentanoic Acids |
| D014631 | Valerates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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| standard of care follow-up | Other | participant follow the standard of care for patient with metastatic prostate cancer |
|
| pre-study, mid-study, end of study (up to 1 year) |
| Number of Participants Who Achieve a Complete Response | Complete response was defined as PSA Doubling Time increasing to greater than 10 months. Blood was drawn monthly during study period (1 year), serum PSA was measured & PSADT calculated. The > 10 month criteria was based on the Pound et al JAMA 1999, Vol 281(No 17) pgs 1591-1697 paper. | one year |
| Number of Participants Who Achieve a Partial Response | Partial Response was defined as any participant that showed an increase in PSA doubling time | one year |
| Functional Assessment of Cancer Therapy - Prostate (FACT-P) Score | Study questionnaire, known as "Functional Assessment of Cancer Therapy - Prostate (FACT-P), were given to participant to complete during study participation. FACT-P is a validated tool to assess self-perceived functionality, psychosocial well-being, and quality of life; and the scoring of the questionnaire was based on the technique published by FACIT (Functional Assessment of Chronic Illness Therapy). The FACT-P is a 39-item questionnaire, with each item being scored from on a Likert scale of 0-4. The total score ranges from 0-156, with a higher score reflecting a better outcome. | at time of enrollment, mid-study, end of study (up to 1 year) |
| Arm II (Valproic Acid) |
Patients receive oral valproic acid twice daily for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients complete quality of life questionnaires at baseline, 6 months, and 1 year. valproic acid: given orally |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Arm II (Valproic Acid) | Patients receive oral valproic acid twice daily for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients complete quality of life questionnaires at baseline, 6 months, and 1 year. valproic acid: given orally |
|
|
| Secondary | Duration of PSA Response as Assessed by PSA Doubling Time (PSADT) | Serum PSA was measured once a month, each month for the one year the subjects were on the protocol. PSA Doubling time is defined as the duration for PSA levels in the blood to increase by 100 percent, and is calculated based on the rate of change in serum PSA values. Prostate-specific antigen doubling time (PSADT) was calculated by natural log of 2 (0.693) divided by the slope of the relationship between the log of PSA and time of PSA measurement for each patient (Pound et al JAMA 1999, Vol 281(No 17) pgs 1591-1697), therefore it can be much greater than the 12 months that we followed the patients for. PSADT was calculated for pre enrollment, at the mid point of the study & at the end of study. | One participant from Arm 1 was lost to follow-up; One participant from Arm II was lost to follow-up and another withdrew consent. | Posted | Mean | Standard Deviation | months | pre-study, mid-study, end of study (up to 1 year) |
|
|
|
| Secondary | Number of Participants Who Achieve a Complete Response | Complete response was defined as PSA Doubling Time increasing to greater than 10 months. Blood was drawn monthly during study period (1 year), serum PSA was measured & PSADT calculated. The > 10 month criteria was based on the Pound et al JAMA 1999, Vol 281(No 17) pgs 1591-1697 paper. | One participant from Arm 1 was lost to follow-up; One participant from Arm II was lost to follow-up and another withdrew consent | Posted | Count of Participants | Participants | one year |
|
|
|
| Secondary | Number of Participants Who Achieve a Partial Response | Partial Response was defined as any participant that showed an increase in PSA doubling time | One participant from Arm 1 was lost to follow-up; One participant from Arm II was lost to follow-up and another withdrew consent | Posted | Count of Participants | Participants | one year |
|
|
|
| Secondary | Functional Assessment of Cancer Therapy - Prostate (FACT-P) Score | Study questionnaire, known as "Functional Assessment of Cancer Therapy - Prostate (FACT-P), were given to participant to complete during study participation. FACT-P is a validated tool to assess self-perceived functionality, psychosocial well-being, and quality of life; and the scoring of the questionnaire was based on the technique published by FACIT (Functional Assessment of Chronic Illness Therapy). The FACT-P is a 39-item questionnaire, with each item being scored from on a Likert scale of 0-4. The total score ranges from 0-156, with a higher score reflecting a better outcome. | One participant from Arm 1 was lost to follow-up; One participant from Arm II was lost to follow-up and another withdrew consent; Average FACT-P scores for both arms at Study enrollment, mid study and at end of study is being reported. | Posted | Mean | Standard Deviation | units on a scale | at time of enrollment, mid-study, end of study (up to 1 year) |
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | Arm II (Valproic Acid) | Patients receive oral valproic acid twice daily for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients complete quality of life questionnaires at baseline, 6 months, and 1 year. valproic acid: given orally | 0 | 8 | 0 | 8 | 0 | 8 |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D009930 |
| Organic Chemicals |
| D005232 | Fatty Acids, Volatile |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| End of study |
|
| End of Study |
|