Sodium Valproate/Metformin Combination therapy for prostate cancer

Phase 1

• Conditions: Prostate cancer; Cancer - Prostate

• Registration Number: ACTRN12616001021460
• Lead Sponsor: Flinders University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-02
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Male
• Target Recruitment: 12

Inclusion Criteria

1 Patients must have histologically confirmed localized or locally advanced prostate cancer – Clinical stage T1c or T2 with high-grade disease (Gleason's 8-10) on initial biopsy, or clinical stage T2b-T2c with Gleason's grade >/= 7 and PSA > 10ng/ml.
2 Must be planned for radical prostatectomy within the next 6-8 weeks
3 No documented metastatic disease on CT or Bone scans. Prostate specific Membrane antigen (PSMA) PET scans allowed – but, not mandatory for establishing non-mestastatic disease
4 Age >18 years.
5 ECOG performance status <1
6 Life expectancy of greater than 12 months
7 Patients must have normal organ and marrow function
8 Not planned for Androgen deprivation therapy
9 Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

1 Patients who have had chemotherapy or radiotherapy or metformin or sodium valproate
2 Patients may not be receiving any other investigational agents.
3 Patients with known metastases
4 History of allergic reactions attributed to compounds of similar chemical composition to the agents used in study.
5 Patients receiving any medications or substances that are inhibitors or inducers of CYP450 3A4 are ineligible. Lists including medications and substances known or with the potential to interact with CYP450 3A4 isoenzymes are provided in product information of the study drugs.
6 Past history of pancreatitis, extensive bowel resection, known urea cycle disorders or porphyria
7 Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
8 Patients with diabetes or known epilepsy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the safety of the combination of Metformin and VPA in men undergoing radical prostatectomy for prostate cancer. <br>Safety will be assessed using the common toxicity critieria (NCI-CTC v1.0) as well as physical examination and blood tests for organ function.[At the end of 4 weeks of commencement of study drug therapy]

Secondary Outcome Measures

Name	Time	Method
To evaluate PSA response using serum assay<br>[Immediately prior to and 4 weeks of study treatment];Incidence of positive surgical margins will be assessed by examination of the surgical specimen post radical prostatectomy<br>[Following radical prostatectomy];To evaluate Ki 67 response using immunohistochemistry in the biopsy specimen[Ki 67 at the end of 4 weeks of study drug therapy will be compared with the baseline];Incidence of pathological response as assessed by examination of the surgical specimen post radical prostatectomy[Following radical prostatectomy']