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Prostate CancerPhase 2NCT00859781

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

A Phase 2 study testing 177Lu-J591, Ketoconazole and Hydrocortisone in people with Prostate Cancer, run by Weill Medical College of Cornell University at 10 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
177Lu-J591, Ketoconazole and Hydrocortisone
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
55 participants
Where
10 sitesUnited States
Study dates
Jun 2009to Jun 2027
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 12Show fewer
  • 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.

Who cannot join

  • 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
Show all 26Show fewer
  • 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
  • Life expectancy <12 months
  • History of deep vein thrombosis and/or pulmonary embolus within 1 month of study entry
  • Other serious illness(es) involving the cardiac, respiratory, CNS, renal, hepatic or hematological organ systems which might preclude completion of this study or interfere with determination of causality of any adverse effects experienced in this study
  • Prior investigational therapy (medications or devices) within 4 weeks of treatment. Furthermore, other investigational therapy is not permitted during the treatment phase.
  • Prior use of ketoconazole for the purposes of prostate cancer therapy for greater than 1 month
  • Known history of HIV. The effects of J591 are unknown in this population. Furthermore, ketoconazole has many well-described drug-drug interactions which could affect antiviral therapy. If necessary, this population will be studied separately.
  • Currently active other malignancy other than non-melanoma skin cancer. Patients are considered not to have "currently active" malignancy if they have completed any necessary therapy and are considered by their physician to be at less than 30% risk of relapse.
  • Known history of known myelodysplastic syndrome
  • Adrenal hormone inhibitors (other than ketoconazole) within 4 weeks prior to study enrollment
  • Finasteride (Propecia® or Proscar®) or dutasteride (Avodart®) within 4 weeks of enrollment
  • Patients on corticosteroids prior to enrollment must have either discontinued and shown biochemical progression or have biochemical progression on a stable dose

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • Indiana University Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • Cedars Sinai

    Los Angeles, California, 90048

  • USC/Norris Comprehensive cancer center

    Los Angeles, California, 90089

  • Weill Cornell Medical College

    New York, New York, 10021

  • XCancer Omaha

    Omaha, Nebraska, 68130

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • University of Utah

    Salt Lake City, Utah, 84108

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

  • The University of Kansas Cancer Center

    Westwood, Kansas, 66205

Other trials in United States

About this study

Official title: A Randomized Phase 2 Trial of 177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu-J591) and Ketoconazole in Patients With High-Risk Castrate Biochemically Relapsed Prostate Cancer After Local Therapy

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.

Read the detailed description

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. Existing treatments, such as the ketoconazole used as part of this study may decrease PSA temporarily, but unfortunately the cancer continues to grow. This experimental drug is designed to seek out all of the prostate cancer cells and to deliver a lethal dose of radiation to the areas of cancer, but not to normal areas. Some of the normal organs (liver, kidney and bone marrow) do receive some radiation dose that is within the acceptable limits.

The experimental drug in this study includes an antibody (abbreviated: mAb) called "J591". It is a protein molecule which can bind to a specific site on a prostate cancer cell. A very energetic radioactive (an unstable atom) metal called 177Lutetium (abbreviated: 177Lu) is attached to the J591 antibody. The fully assembled drug is called "177Lu-J591". The study will assess the potential of the energy given off by the radioactive compound to kill cancer cell. This study may also involve the use of 111Indium (abbreviated 111In). This is also an energetic radioactive particle, but does not generally give off enough energy to kill cancer cells, but allows researchers to take pictures. This radioactive particle is also attached to the J591 antibody (called 111In-J591) and will serve as a placebo (treatment with no active medicine).

Conditions
Prostate Cancer
Being tested
177Lu-J591, Ketoconazole, Hydrocortisone, 111In-J591
Keywords
Prostate
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 177Lu-J591Drug

    Also called J591

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

  • KetoconazoleDrug

    Also called Nizoral

    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)

  • HydrocortisoneDrug

    Also called Cortef

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

  • 111In-J591Drug

    Also called J591

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

Study groups in NCT00859781
Study groupRoleWhat they receive
1. 177Lu-J591 + KetoconazoleExperimentalKetoconazole 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
Receives: Drug: 177Lu-J591; Drug: Ketoconazole; Drug: Hydrocortisone
2. 111In-J591 + KetoconazolePlacebo comparatorKetoconazole 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
Receives: Drug: Ketoconazole; Drug: Hydrocortisone; Drug: 111In-J591

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline and 18 months after study drug administration

Secondary outcomes (1)

  1. Change in PSA Response Rate

    PSA response will be determined by comparing the PSA levels after therapy to the baseline and pre-treatment PSA via blood specimens

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2009 (estimated)
  2. Study startJun 2009
  3. Primary completion10 Feb 2022
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00859781
Sponsor's protocol ID
0810010067
Other IDs
J591+Ketoconazole
Status last verified
Oct 2026
First submitted
10 Mar 2009
Last updated
5 Nov 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 177Lu-J591, Ketoconazole and Hydrocortisone in people with Prostate Cancer, run by Weill Medical College of Cornell University at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Participants Free of Radiographically Evident Metastases From Baseline to 18 Months After Study Drug Administration (time frame: Baseline and 18 months after study drug administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00859781.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.

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