177Lu-J591 + Ketoconazole for Prostate Cancer

Recruiting in Palo Alto (17 mi)

+8 other locations

Overseen byScott T Tagawa, M.D.

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Weill Medical College of Cornell University

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

Men over 18 with advanced prostate cancer that's worsened after surgery or radiotherapy can join. They must have a rising PSA level, no signs of the cancer spreading significantly, and low testosterone. Participants should not be at high risk of other serious illnesses and agree to use contraception if they can father children.

Inclusion Criteria

My prostate cancer was confirmed by a lab test and I've had surgery or radiotherapy.

High risk of systemic progression defined as: Rising PSA with Absolute PSA > 20 ng/mL and/or PSA doubling time < 8 months, No evidence of local recurrence or distant metastases, Age >18 years, Serum testosterone < 50 ng/ml, Patients capable of fathering children must agree to use an effective method of contraception for the duration of the trial, Subjects on bisphosphonate therapy must be on a stable dose and must have started therapy > 4 weeks prior to protocol therapy, Ability to understand and the willingness to sign a written informed consent document

My prostate cancer is worsening despite hormone therapy.

Exclusion Criteria

My platelet count is below 150,000 or I have a known platelet disorder.

Serum creatinine >2.5 mg/dL

AST (SGOT) >2x ULN

+23 more

Participant Groups

The trial is testing an experimental drug called 177Lu-J591 combined with ketoconazole and hydrocortisone on prostate cancer patients. It aims to see how effective this combination is in controlling the progression of the disease.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: 1. 177Lu-J591 + KetoconazoleExperimental Treatment3 Interventions

Ketoconazole 400 mg 3 times a day plus hydrocortisone 20 mg AM, 10 mg PM x 4 weeks followed by 177Lu-J591 Infusion, continue ketoconazole and hydrocortisone

Group II: 2. 111In-J591 + KetoconazolePlacebo Group3 Interventions

Ketoconazole 400 mg 3 times a day plus hydrocortisone 20 mg AM, 10 mg PM x 4 weeks followed by 111In-J591 (placebo) Infusion, continue ketoconazole and hydrocortisone