A Research Study for Patients With Prostate Cancer (NCT00106418) | Clinical Trial Compass
CompletedPhase 2
A Research Study for Patients With Prostate Cancer
35 participantsStarted 2003-05-07
Plain-language summary
The purpose of this study is to evaluate the activity of romidepsin (depsipeptide,FK228) in patients with metastatic prostate cancer who have developed a rising prostate specific antigen (PSA) while undergoing hormonal therapy.
Who can participate
Age range18 Years
SexMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Males ≥18 years;
* Written informed consent/authorization;
* Histological or cytological confirmation of metastatic prostate cancer with documented progression on hormonal therapy (objective progressive disease \[PD\], new bone lesions, or stable soft tissue or bone lesions with PSA increase);
* Patients must have either measurable disease or bone metastasis. Patients with measurable disease are preferred;
* Rising PSA, with a minimum study entry PSA of ≥5 ng/mL;
* Karnofsky performance status of ≥80%;
* Life expectancy of \>12 weeks;
* For patients treated with anti-androgens, elevation of PSA must be demonstrated after cessation of anti-androgen treatment;
* Three lines of hormonal therapy are permitted prior to study entry (anti-androgen withdrawal is not considered as a second hormonal treatment);
* Serum testosterone level of \<50 ng/mL in patients without surgical castration;
* Patients must have serum potassium levels \>4.0 mEq/L and serum magnesium levels \>2.0 mg/dL.
Exclusion Criteria:
* Concomitant use of any anti-cancer therapy, except for continued use of luteinizing hormone-releasing hormone (LHRH) agonists or antiandrogens, or bisphosphonates or steroids initiated at least 4 weeks prior to study entry;
* Concomitant use of any investigational agent, including PC-SPES;
* Use of any investigational agent within 4 weeks of study entry;
* Concomitant use of warfarin (due to a potential drug-to-drug interaction with depsipeptide);
* Major su…