177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu-J591) and Ketoconazole in Patients With Prostate Cancer

NCT00859781 | Active Not Recruiting Phase 2 Results DMC FDA Drug

• 2 other identifiers: 0810010067J591+Ketoconazole
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 9

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

Prostate

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants Free of Radiographically Evident Metastases From Baseline to 18 Months After Study Drug Administration

  Subjects will perform a CT and/or MRI scan of the abdomen and pelvis, chest x-ray or CT scan of the chest and bone scan to determine the proportion of participants free of radiographically evident metastases from baseline to 18 months after study drug administration.

  Baseline and 18 months after study drug administration

Secondary Outcomes (1)

• Change in PSA Response Rate

  Collected at screening, V2, V3, V5, V9 then every 4 weeks till PSA progression or end of study at approximately 100 months

Study Arms (2)

1. 177Lu-J591 + Ketoconazole

EXPERIMENTAL

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

Drug: 177Lu-J591; Drug: Ketoconazole; Drug: Hydrocortisone

2. 111In-J591 + Ketoconazole

PLACEBO COMPARATOR

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

Drug: Ketoconazole; Drug: Hydrocortisone; Drug: 111In-J591

Interventions

177Lu-J591 DRUG

177Lu-J591 70 mCi/m2 on day 29 (+/- 2 days) of treatment

Also known as: J591

1. 177Lu-J591 + Ketoconazole

Ketoconazole DRUG

Ketoconazole at a dose of 400 mg (two 200 mg tabs) to be taken orally (preferably on an empty stomach) three times per day (total daily dose of 1200 mg)

Also known as: Nizoral

1. 177Lu-J591 + Ketoconazole; 2. 111In-J591 + Ketoconazole

Hydrocortisone DRUG

Hydrocortisone at a dose of 20 mg orally each morning, 10 mg orally each evening (total daily dose of 30 mg)

Also known as: Cortef

1. 177Lu-J591 + Ketoconazole; 2. 111In-J591 + Ketoconazole

111In-J591 DRUG

111In-J591 at a dose of 5 mCi on day 29 (+/- 2 days) of treatment

Also known as: J591

2. 111In-J591 + Ketoconazole

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 defined as:
• Rising PSA as defined above and either:
• 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.

You may not qualify if:

• Use of red blood cell or platelet transfusions within 4 weeks of treatment
• Use of hematopoietic growth factors within 4 weeks of treatment
• Prior cytotoxic chemotherapy and/or radiation therapy within 4 weeks of treatment
• Prior radiation therapy encompassing \>25% of skeleton (see Appendix C)
• Prior treatment with 89Strontium or 153Samarium containing compounds (e.g. Metastron®, Quadramet®)
• Platelet count \<150,000/mm3 or known primary qualitative platelet disorder
• Absolute neutrophil count (ANC) \<2,000/mm3
• Hematocrit \<30 percent and Hemoglobin \< 10 g/dL
• Abnormal coagulation profile (PT or INR, PTT \> 1.3x ULN) unless on therapeutic anticoagulation - see concomitant meds section
• Serum creatinine \>2.5 mg/dL
• AST (SGOT) \>2x ULN
• Bilirubin (total) \>1.5x ULN; subjects with Gilbert's syndrome will be allowed if direct bilirubin is within institutional normal limits
• Active serious infection
• Active angina pectoris or NY Heart Association Class III-IV
• ECOG Performance Status \> 2

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• United States Department of Defense: collaborator

Study Sites (9)

Cedars Sinai

Los Angeles, California, 90048, United States

Location

USC/Norris Comprehensive cancer center

Los Angeles, California, 90089, United States

Location

Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

The University of Kansas Cancer Center

Westwood, Kansas, 66205, United States

Location

Weill Cornell Medical College

New York, New York, 10021, United States

Location

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

University of Utah

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

J591 monoclonal antibody; Ketoconazole; Hydrocortisone

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids

Results Point of Contact

• Title: Scott Tagawa
• Organization: Weill Cornell Medicine

stt2007@med.cornell.edu

6469622072

Study Officials

• Scott T Tagawa, M.D.

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2009
• First Posted: March 11, 2009
• Study Start: June 1, 2009
• Primary Completion: February 10, 2022
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 8, 2026
• Results First Posted: July 19, 2023

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)