0810010067/J591; A Randomized Phase II Trial of 177-Lu Radio-labeled Monoclonal Antibody HuJ591 (177-Lu-J591) with Ketoconazole in Patients with High-Risk Castrate Biochemically Relapsed Prostate Cancer after Local Therapy

Study of Investigational Medication with Other Medications for Prostate Cancer

Recruiting
18 years - 100 years
Male
Phase N/A
1 Location

Brief description of study.

The purpose of this study is to test the effectiveness of the experimental drug, 177Lu-J591 in combination with ketoconazole and hydrocortisone against prostate cancer.

Detailed description of study

This research is being done because the standard treatments for prostate cancer that has returned (PSA is elevated) after surgery and/or radiation and progressed on initial hormonal therapy are not curative. The study will assess the potential of the energy given off by the radioactive compound to kill cancer cell.

Participants will not be paid for their participation.
Participants will not be paid for their participation.
Participants will not be paid for their participation.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Prostate Cancer,Relapsed Prostate Cancer,Prostate,Cancer,Oncology
  • Age: 18 years - 100 years
  • Gender: Male

Inclusion Criteria
Histologically or cytologically confirmed adenocarcinoma of the prostate previously treated with surgery and/or radiotherapy
Biochemical progression (rising PSA) after medical or surgical castration
High risk of systemic progression
Exclusion Criteria
Use of red blood cell or platelet transfusions within 4 weeks of treatment
Use of hematopoietic growth factors within 4 weeks of treatment
Active serious infection
History of deep vein thrombosis and/or pulmonary embolus within 3 months of study entry
Known history of HIV.
Currently active other malignancy other than non-melanoma skin cancer.

Updated on 19 Feb 2024. Study ID: 1011003440 (1004-12)

This study investigates the use of an investigational medication combined with ketoconazole and hydrocortisone for treating prostate cancer. Prostate cancer is a disease where cancer cells form in the tissues of the prostate. The study aims to explore how the energy from a radioactive compound can potentially kill cancer cells, especially in cases where the cancer has returned after surgery or radiation and has not responded to initial hormonal therapy.

Participants in the study will receive a combination of investigational medication, ketoconazole, and hydrocortisone. The investigational medication is a substance being tested to see if it can help treat prostate cancer more effectively. Ketoconazole and hydrocortisone are medications that help manage hormone levels and inflammation.

  • Who can participate: Men with prostate cancer confirmed by diagnosis, treated with surgery or radiotherapy, and showing biochemical progression after castration can participate. They should be at high risk of systemic progression and must not have recently used blood or platelet transfusions, growth factors, or have active infections.
  • Study details: Participants will be given an investigational medication alongside other medications. A placebo is not used in this study.

Find a site

Message sent successfully.
We have submitted the information you provided to the research team at the location you chose. For your records, we have sent a copy of the message to your email address.
If you would like to be informed of other studies that may be of interest to you, you may sign up for Patient Notification Service.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Preferred way of contact label
Race
Ethnicity
Other language

Default Content Message Here