CompletedPhase 2

Phase II Study of DCVAC/PCa Added to Hormone Therapy for Men With Metastatic Prostate Cancer

Czechia63 participantsStarted 2012-03

Plain-language summary

The purpose of this study is to determine whether DCVAC/PCa added onto hormone therapy can improve PSA progression times for patients with Metastatic Prostate Cancer.

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: * Male 18 years and older * Histologically confirmed prostate adenocarcinoma * Presence of bone or soft tissue metastasis (by CT or PET or MRI and/or scintigraphy) * Androgen deprivation therapy using Luteinizing-hormone-releasing hormone ( LHRH) analogues commenced at least one month and at most three months prior randomization or orchiectomy performed at least one month and at most three months prior randomization * Serum testosterone level at screening (≤ 1.7 nmol/l, resp. ≤ 50 ng/dL) * Eastern Cooperative Oncology Group (ECOG) 0-2 Exclusion Criteria: * Confirmed brain and/or leptomeningeal metastases * Prior or ongoing chemotherapy for prostate cancer * Peripheral neuropathy of Common Toxicity Criteria (CTC) grade 2 or greater * Other uncontrolled intercurrent illness * Treatment with immunotherapy against prostate cancer * Clinically significant cardiovascular disease * Active autoimmune disease requiring treatment

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.

What they're measuring

Proportion of patients with PSA Progression

Timeframe: 104 weeks

Trial details

NCT IDNCT02107391

SponsorSOTIO a.s.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-12

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