Prostate CancerPhase 2NCT00670046
Valproic Acid in Treating Patients With Progressive, Non-Metastatic Prostate Cancer
A Phase 2 study testing valproic acid in people with Prostate Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- valproic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Jul 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed prostate cancer
- Asymptomatic, non-metastatic disease
- Biochemical progression after definitive local therapy (radical prostatectomy)
- Most recent prostate-specific antigen (PSA) level ≥ 1.0 ng/mL AND rising over the prior value
- No clinical or radiological evidence of local progression
- PSA doubling time (DT) < 10 months after local therapy (in patients who have not received prior hormone therapy)
- At least three PSA values (each at least 4 weeks apart) are required to calculate the PSA-DT
- No clinical or radiological evidence of metastatic disease, including bone metastasis
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy > 3 months
- Total bilirubin normal
- AST/ALT < 2.5 times upper limit of normal
- Creatinine ≤ 2.5 mg/dL
- Platelet count > 125,000/mm^3
- PT and aPTT ≤ 1.3 times above the standard reference
- Albumin ≥ 3.5 g/dL
- Geographically accessible and willing to participate in all stages of study treatment
- No active second malignancy
- No known HIV positivity
- No active, uncontrolled infection (e.g., hepatitis A, B, or C infection)
- No history of allergic reactions attributed to compounds of similar chemical or biological composition to valproic acid
- No debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal study treatment and follow-up
- No history of hepatic disease or significant hepatic dysfunction
- No history of pancreatitis
- No history of seizure disorder or clinically treated bipolar disorder
PRIOR CONCURRENT THERAPY:
- More than 6 months since prior hormone therapy
- No prior valproic acid
- At least 2 weeks since prior drugs specifically known to interact with valproic acid including, but are not limited to, aspirin, felbamate, rifampin, amitriptyline/nortriptyline, carbamazepine, clonazepam, diazepam, ethosuximide, lamotrigine, phenobarbital, primidone, phenytoin, tolbutamide, warfarin, or zidovudine
- No concurrent systemic chemotherapy for prostate cancer
- No other concurrent investigational drugs
Trial locations and contacts
1 site in 1 country.
United States1 site
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
About this study
Official title: Randomized, Controlled Phase II Study of Valproic Acid in Patients With Non-metastatic Biochemical Progression of Prostate Cancer
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.
Read the detailed description
OBJECTIVES:
Primary
- Assess whether treatment with valproic acid (a type I histone deacetylase inhibitor) can alter the kinetics of prostate-specific antigen (PSA) progression in patients with non-metastatic prostate cancer and biochemical progression.
Secondary
- Determine the duration of PSA response.
- Assess the percentage of patients who achieve a complete response.
- Assess the percentage of patients who achieve a partial response.
- Assess the quality of life of these patients.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 arms.
- Arm I (observation): Patients undergo observation according to standard of care.
- 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.
- Conditions
- Prostate Cancer
- Being tested
- valproic acid, standard of care follow-up
- Keywords
- recurrent prostate cancer, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
valproic acidDrug
Also called VPA
given orally
standard of care follow-upOther
participant follow the standard of care for patient with metastatic prostate cancer
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: standard of care follow-up |
| 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. Receives: Drug: valproic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 year
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: at time of enrollment, mid-study, end of study (up to 1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2008 (estimated)
- Study startMay 2008
- Primary completionJul 2012
- Study completionJul 2012
Why it stopped: The study was terminated per the PI decision.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Ronald Rodriguez, MD, PhD, Principal investigator, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00670046
- Sponsor's protocol ID
- J07122
- Other IDs
- P30CA068485, CDR0000595004, NA_00010227
- Status last verified
- Sep 2018
- First submitted
- 30 Apr 2008
- Last updated
- 28 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled Phase II Study of Valproic Acid in Patients With Non-metastatic Biochemical Progression of Prostate Cancer
- ClinicalTrials.gov ID
- NCT00670046
- Acronym / sponsor ID
- J07122
- Conditions
- Prostate Cancer
- Keywords
- recurrent prostate cancer, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated per the PI decision.
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2008
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 1 May 2008 (estimated)
- Results
- Posted 28 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
OBJECTIVES:
Primary
- Assess whether treatment with valproic acid (a type I histone deacetylase inhibitor) can alter the kinetics of prostate-specific antigen (PSA) progression in patients with non-metastatic prostate cancer and biochemical progression.
Secondary
- Determine the duration of PSA response.
- Assess the percentage of patients who achieve a complete response.
- Assess the percentage of patients who achieve a partial response.
- Assess the quality of life of these patients.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 arms.
- Arm I (observation): Patients undergo observation according to standard of care.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (standard of care) | Other | Other: standard of care follow-upPatients 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 | Drug: valproic acidPatients 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| valproic acidAlso: VPAgiven orally | Drug | Arm II (valproic acid) |
| standard of care follow-upparticipant follow the standard of care for patient with metastatic prostate cancer | Other | Arm I (standard of care) |
Primary outcome
Number of Participants Exhibiting an Increase in Observed or Predicted Prostate-specific Antigen (PSA) Doubling Time
Time frame: 1 year
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).
4 secondary outcomes
Duration of PSA Response as Assessed by PSA Doubling Time (PSADT)
Time frame: pre-study, mid-study, end of study (up to 1 year)
Number of Participants Who Achieve a Complete Response
Time frame: one year
Number of Participants Who Achieve a Partial Response
Time frame: one year
Functional Assessment of Cancer Therapy - Prostate (FACT-P) Score
Time frame: at time of enrollment, mid-study, end of study (up to 1 year)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald Rodriguez, MD, PhD principal investigator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing valproic acid in people with Prostate Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Exhibiting an Increase in Observed or Predicted Prostate-specific Antigen (PSA) Doubling Time (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2018; AzTrials last refreshed its copy on 6 Nov 2026.