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

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.

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 04 Aug 2024. Study ID: 1011003440 (1004-12)

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