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Contact Information:

Dr Andrew Hudson


Mrs Larissa Bates
+44 1494567444
janssenukregistryqueries@its.jnj.com


Dr Medical Information & Product Information Enquiry
+44 8007318450 / +44 1494567444
medinfo@its.jnj.com


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Be Part of Research - Trial Details - A study of JNJ-80038114 in participants with advanced stage prostate cancer
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A study of JNJ-80038114 in participants with advanced stage prostate cancer

Not Recruiting

Open to: Male

Age: Adult

Manchester Sutton London Nashville

Medical Conditions

Prostate cancer

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


The purpose of this study is to see if a new study drug can be used in future studies for the treatment of prostate cancer. During the study, side effects caused by the study drug will be followed closely, as well as how long the study drug stays in the body and how the body responds to it.
This is the first time that the study drug is being tested in humans. It is not approved for use by humans in any country.
Therefore, Part 1 of the study will start with the administration of a low dose of the study drug. After reviewing the results obtained at each dose level, it will be decided whether or how much to increase the dose for subsequent participants.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

14 Dec 2022 19 Jan 2024

This study consists of a screening phase, a treatment phase and an end-of-treatment visit. All participants will receive the study drug via subcutaneous (below the skin) injections. The dose and frequency of the injections will depend on when a participant enters the study.
The duration of participation is determined by the duration of the study drug administration.
Administration of the study drug will last as long as a participant benefits and does not have unmanageable side effects. In addition, participants and physicians can decide to stop the study drug at any time.
At study visits, a participant will have procedures such as blood and urine tests, ECG, physical exam, CT / MRI or bone scan. An additional fresh tumour biopsy may be collected during Part 2 of the study. Hospitalisation will also be required to monitor for any side effects during the first one or more doses of the study drug in Part 1.


This study will include participants aged 18 years and over with metastatic castration-resistant prostate cancer.

You can take part if:



You may not be able to take part if:


1. Concurrent anticancer therapy2. Severe or long-lasting side effects related to prior anticancer therapy3. Known allergies to JNJ-80038114 or its excipients4. Brain metastasis or known seizure history5. Significant infections or lung, heart or other medical conditions


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • The Christie NHS Foundation Trust - Christie Hospital
    Manchester
    M20 4BX
  • The Royal Marsden hospital
    Sutton
    SM2 5PT
  • University College London Hospital (ULCH)
    London
    NW1 2PG
  • Sarah Cannon Research Institute
    Nashville
    37203

This is the first study of this study drug in humans. It is possible that taking part in this study could improve a participant’s condition, but this is not guaranteed to happen.
During the study, a participant’s condition may stay the same or get worse.
Based on clinical trials of other active substances that target prostate‐specific membrane antigen (also referred to as PSMA, a common protein in patients with prostate cancer) and the immune system, potential side effects have been outlined in the participant information sheet. This sheet will be signed by every participant agreeing to participate in the study and includes a section describing these potential side effects.
This is the first time the study drug will be given to humans, so we do not yet know if these potential side effects will occur or how frequently they may occur. Different side effects may occur. There may be risks to using the study drug that we don’t know yet.
Tests and procedures will be done during the study to monitor side effects. Participants will also be educated to report any symptoms they experience during the study to their study doctor, even if they do not think the side effects are related to the study drug or procedures.

Dr Andrew Hudson


Mrs Larissa Bates
+44 1494567444
janssenukregistryqueries@its.jnj.com


Dr Medical Information & Product Information Enquiry
+44 8007318450 / +44 1494567444
medinfo@its.jnj.com



The study is sponsored by Janssen-Cilag International NV and funded by Janssen-Cilag International NV.




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What will you do next?
Read full details for Trial ID: ISRCTN16457874

Or CPMS 53090

Last updated 24 April 2024

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