Trial Outcomes & Findings for Valproic Acid in Treating Patients With Progressive, Non-Metastatic Prostate Cancer (NCT NCT00670046)

Last Updated: 2018-09-28

Results Overview

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).

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

15 participants

Primary outcome timeframe

1 year

Results posted on

2018-09-28

Participant Flow

Participant milestones

Participant milestones
Measure	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	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
Overall Study STARTED	7	8
Overall Study COMPLETED	6	6
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	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	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
Overall Study Lost to Follow-up	1	1
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Valproic Acid in Treating Patients With Progressive, Non-Metastatic Prostate Cancer

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 1 year

Population: One participant from Arm 1 was lost to follow-up; One participant from Arm II was lost to follow-up and another withdrew consent

Outcome measures

Outcome measures
Measure	Arm I (Standard of Care) n=6 Participants 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	Arm II (Valproic Acid) n=6 Participants 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
Number of Participants Exhibiting an Increase in Observed or Predicted Prostate-specific Antigen (PSA) Doubling Time	3 Participants	5 Participants

SECONDARY outcome

Timeframe: pre-study, mid-study, end of study (up to 1 year)

Population: One participant from Arm 1 was lost to follow-up; One participant from Arm II was lost to follow-up and another withdrew consent.

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.

Outcome measures

Outcome measures
Measure	Arm I (Standard of Care) n=6 Participants 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	Arm II (Valproic Acid) n=6 Participants 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
Duration of PSA Response as Assessed by PSA Doubling Time (PSADT) Pre-Study	6.3 months Standard Deviation 1.9	4.0 months Standard Deviation 2.8
Duration of PSA Response as Assessed by PSA Doubling Time (PSADT) Mid-Study	6.9 months Standard Deviation 4.0	14.1 months Standard Deviation 9.9
Duration of PSA Response as Assessed by PSA Doubling Time (PSADT) End of study	7.0 months Standard Deviation 3.8	40.7 months Standard Deviation 46.1

SECONDARY outcome

Timeframe: one year

Population: One participant from Arm 1 was lost to follow-up; One participant from Arm II was lost to follow-up and another withdrew consent

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.

Outcome measures

Outcome measures
Measure	Arm I (Standard of Care) n=6 Participants 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	Arm II (Valproic Acid) n=6 Participants 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
Number of Participants Who Achieve a Complete Response	1 Participants	4 Participants

SECONDARY outcome

Timeframe: one year

Population: One participant from Arm 1 was lost to follow-up; One participant from Arm II was lost to follow-up and another withdrew consent

Partial Response was defined as any participant that showed an increase in PSA doubling time

Outcome measures

Outcome measures
Measure	Arm I (Standard of Care) n=6 Participants 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	Arm II (Valproic Acid) n=6 Participants 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
Number of Participants Who Achieve a Partial Response	2 Participants	1 Participants

SECONDARY outcome

Timeframe: at time of enrollment, mid-study, end of study (up to 1 year)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Arm I (Standard of Care) n=6 Participants 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	Arm II (Valproic Acid) n=6 Participants 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
Functional Assessment of Cancer Therapy - Prostate (FACT-P) Score at time of Study Enrollment	133 units on a scale Standard Deviation 7.5	138.5 units on a scale Standard Deviation 5.5
Functional Assessment of Cancer Therapy - Prostate (FACT-P) Score Mid Study	134.8 units on a scale Standard Deviation 4.1	126.6 units on a scale Standard Deviation 23.4
Functional Assessment of Cancer Therapy - Prostate (FACT-P) Score End of Study	133.2 units on a scale Standard Deviation 10.3	90.4 units on a scale Standard Deviation 42.3

Adverse Events

Arm I (Standard of Care)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm II (Valproic Acid)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ron Rodriguez, MD, PhD

UTHSCSA

Phone: 2105675643

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Arm I (Standard of Care) n=6 Participants 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	Arm II (Valproic Acid) n=6 Participants 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	Total n=12 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants