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Prostate CancerPhase 2NCT00195039

Treatment With Radiolabeled Monoclonal Antibody HuJ591-GS (177Lu-J591) in Patients With Metastatic Prostate Cancer

A Phase 2 study testing 177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu -J591) in people with Prostate Cancer, run by Weill Medical College of Cornell University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to find out how effective 177Lu -J591 is in the treatment of patients with metastatic, androgen-independent 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 Radiolabeled Monoclonal Antibody HuJ591 (177Lu -J591)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
1 siteUnited States
Study dates
Aug 2004to Oct 2013
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

  • Histologic diagnosis of prostate adenocarcinoma.
  • Metastatic prostate cancer progressive on imaging studies and/or rising PSA despite adequate medical or surgical castration therapy.
  • Progressed following discontinuation of anti-androgen therapy, if received.
  • Serum testosterone < 50 ng/ml

Who cannot join

  • Use of corticosteroids and/or adrenal hormone inhibitors within 4 weeks of treatment.
  • Use of PC-SPES within 4 weeks of treatment.
  • 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.
  • Bone scan demonstrating confluent lesions involving both axial and appendicular skeleton.
Show all 14Show fewer
  • Prior radiation therapy encompassing >25% of skeleton.
  • Prior treatment with 89Strontium or 153Samarium containing compounds (e.g. Metastron®, Quadramet®).
  • Active angina pectoris or NY Heart Association Class III-IV.
  • History of deep vein thrombophlebitis and/or pulmonary embolus within 3 months 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 monoclonal antibody therapy with the exception of ProstaScint®
  • Prior investigational therapy (medications or devices) within 6 weeks of treatment.
  • Known history of HIV

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Weill Medcial College of Cornell University

    New York, New York, 10065

Other trials in United States

About this study

Official title: A Phase 2 Trial of 177Lu Radiolabeled Monoclonal Antibody HuJ591-GS (177Lu-J591) in Patients With Metastatic Androgen-Independent Prostate Cancer

The purpose of this study is to find out how effective 177Lu -J591 is in the treatment of patients with metastatic, androgen-independent prostate cancer.

Read the detailed description

To determine the clinical activity of 177Lu -J591 for the treatment of patients with metastatic, androgen-independent prostate cancer.

Patients will receive a single dose of J591 (total antibody of 20 mg) consisting of antibody chelated with 177Lu at a dose of 65 or 70 mCi/m2 with a specific activity of 12-15 mCi/mg plus non-radiolabeled antibody.

Conditions
Prostate Cancer
Being tested
177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu -J591)
Keywords
Prostate Cancer
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 Radiolabeled Monoclonal Antibody HuJ591 (177Lu -J591)Drug

    Eligible patients will receive a single dose of 177Lu-J591 (65 or 70 mCi/m2) consisting of J591 chelated at a specific activity of 12-15 mCi of 177Lu per mg of antibody plus sufficient non-radiolabeled, non-DOTA-conjugated ("naked") J591 to achieve a total antibody dose of 20 mg. Each dose will be administered by an IV infusion at a rate not to exceed 5 mg/min.

Study groups in NCT00195039
Study groupRoleWhat they receive
All patientsExperimentalEligible patients will receive a single dose of 177Lu-J591 (65 or 70 mCi/m2) consisting of J591 chelated at a specific activity of 12-15 mCi of 177Lu per mg of antibody plus sufficient non-radiolabeled, non-DOTA-conjugated ("naked") J591 to achieve a total antibody dose of 20 mg. Each dose will be administered by an IV infusion at a rate not to exceed 5 mg/min.
Receives: Drug: 177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu -J591)

What is being measured

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

  1. Define the PSA Response Rate.

    PSA response rate corresponds to change form baseline in PSA at any of the time points specified.

    Measured: At baseline, Day 1, 29, 43, 57, 85, week 18, week 24 & every 12 weeks

  2. Define the Measurable Disease Response Rate.

    Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.

    Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

    Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study

    Measured: Disease will be assessed at baseline and day 85.

Secondary outcomes (6)

  1. Define the Duration of Biochemical PSA and/or Measurable Disease Response.

    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions, Complete Response (CR) = Disappearance of all target lesions, Partial Response (PR) = A </=30% decrease in the sum of the longest diameter of target lesions, taking as reference the Baseline sum longest diameter, Stable Disease (SD) = Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started, Progressive Disease (PD) = A >/=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started, or the appearance of one or more new lesions

    Measured: At baseline, and up to death

  2. Define the Toxicity of 177Lu-J591 Given as Single Dose.

    Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.

    Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL*.

    Grade 3 Severe or medically significant but not immediately life-threatening hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL**.

    Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.

    Measured: From baseline until end of treatment phase (12 weeks)

  3. Define the Incidence of Human Anti-J591 Antibody (HAHA) Response.

    Measured: HAHA samples will be drawn at baseline and Day 85.

  4. Number of Participants With Hematological Toxicity Relative to Bone Marrow Involvement (Bone Scan Index).

    Bone scan score determined for each patient and related to the degree of hematological toxicity quantified by % decline of nadir platelet count relative to baseline count.

    Measured: Bone scan will be performed at baseline and Day 85.

  5. Assess the Survival Rate of Patients Following Treatment.

    Measured: From baseline through study completion

  6. Number of Participants With Targeting of 177Lu-J591 to Known Tumor Sites.

    Measured: Scans will be performed between day 6 and 8.

Timeline

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

  1. First posted19 Sep 2005 (estimated)
  2. Study startAug 2004
  3. Primary completionFeb 2012
  4. Study completionOct 2013

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00195039
Sponsor's protocol ID
0304006100
Other IDs
0304006100
Status last verified
Sep 2017
First submitted
14 Sep 2005
Last updated
5 Oct 2017
Individual data sharing
No

Publications

  • S.T. Tagawa; M.I. Milowsky; M. J. Morris; S. Vallabhajosula; S. Goldsmith; D. Matulich; J. Kaplan; F. Berger; H. I. Scher; N. H. Bander; D. M. Nanus. Phase II trial of 177Lutetium radiolabeled anti-prostate-specific membrane antigen (PSMA) monoclonal antibody J591 in patients with metastatic castrate-resistant prostate cancer. J Clin Oncol 26: 2008 (May 20 suppl; abstr 5140)

  • Tagawa ST, Milowsky MI, Morris M, Vallabhajosula S, Christos P, Akhtar NH, Osborne J, Goldsmith SJ, Larson S, Taskar NP, Scher HI, Bander NH, Nanus DM. Phase II study of Lutetium-177-labeled anti-prostate-specific membrane antigen monoclonal antibody J591 for metastatic castration-resistant prostate cancer. Clin Cancer Res. 2013 Sep 15;19(18):5182-91. doi: 10.1158/1078-0432.CCR-13-0231. Epub 2013 May 28.

    PubMed 23714732

  • Vlachostergios PJ, Niaz MJ, Skafida M, Mosallaie SA, Thomas C, Christos PJ, Osborne JR, Molina AM, Nanus DM, Bander NH, Tagawa ST. Imaging expression of prostate-specific membrane antigen and response to PSMA-targeted beta-emitting radionuclide therapies in metastatic castration-resistant prostate cancer. Prostate. 2021 Apr;81(5):279-285. doi: 10.1002/pros.24104. Epub 2021 Jan 19.

    PubMed 33465252

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu -J591) in people with Prostate Cancer, run by Weill Medical College of Cornell University at 1 site 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 4 inclusion and 14 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: finished, as of the sponsor's last update on 5 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. 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 5 Oct 2017). 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?

Define the PSA Response Rate. (time frame: At baseline, Day 1, 29, 43, 57, 85, week 18, week 24 & every 12 weeks). The study lists 2 primary outcomes in all. 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 NCT00195039, which also lists 3 linked publications.

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 Oct 2017.

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