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 range
18 Years
Sex
MALE
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.