Evaluation of Nivolumab plus Docetaxel in men with Prostate Cancer

Purpose

The purpose of this trial is to study whether the condition of patients with castration-resistant prostate cancer improves on Nivolumab plus Docetaxel.

Costs

Participation in the clinical trial is free of charge.

Condition

Prostate Cancer

Trial phase

Phase 3 trial (what are the 4 phases of clinical trials?)

Countries

Brazil, France, Poland, Romania, Turkey

Which Prostate Cancer patients can access this clinical trial?

Patients who wish to participate in this clinical trial need to fulfill a number of eligibility criteria. Some are very specific and we will require the medical records from your doctor.

You could be eligible if:

  • You can take part in the trial in Brazil, France, Poland, Romania, Turkey;
  • You have a diagnosis of prostate cancer (without small cell features);
  • You have current evidence of metastatic disease;
  • You have an ECOG performance status 0-1
  • You are doing an ongoing androgen deprivation therapy (ADT). For participants who have not had an orchiectomy, this therapy must have been initiated at least 4 weeks before the first dose of trial treatment and treatment must be continued throughout the trial;
  • You have a documented prostate cancer progression as per PCWG3 criteria within 6 months before the trial.

If you meet all of these conditions you might be allowed to enter the screening process.

You are not eligible if:

  • You have or you are suspected of having an autoimmune disease. Exceptions: type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment.
  • You have previously tested positive for HIV or have AIDS;
  • You have an uncontrolled illness such as: ongoing or active infection, history of congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness that can stop you from following the clinical trial requirements;
  • You have been under treatment with antibodies such as: anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4;You have been under treatment with docetaxel or another chemotherapy agent for metastatic castration resistant prostate cancer. Exception: if 12 months have passed from your last dose of docetaxel;
  • You have been under treatment with radium-223 or other therapeutic radiopharmaceuticals for prostate cancer.

If you meet all of these conditions you might be allowed to enter the screening process.

Learn how to access this clinical trial

If you meet the conditions and you would like to participate in this study, please register your interest by filling in the Participation Form and we will contact you shortly with additional information on the screening process.

Be fully informed before you show interest in taking part in this study

Joining a clinical trial study can be unnerving for both you and your loved ones, which is why you first need to consult your treating doctor to weigh up the pros and cons. We will try to give you all the information you and your doctor need, so you and your doctor can make the best decision for you.

Please be aware that as part of the screening process you and your doctor will need to send us your medical records.

Be aware:

  • Being selected for the study depends on whether you are eligible for the trial;
  • At all times your data will be kept safe and protected;
  • If you join the trial, you could be randomly assigned to a placebo group.

Yes, I want to participate

Fill in the form below so we can contact you with more details about this study.

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Thank you for registering your interest in this clinical trial!

We will get in touch with you shortly at . If you have any questions, send an email to [email protected]

458 Evaluation of Nivolumab plus Docetaxel in men with Prostate Cancer