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Castration-Resistant Prostatic CancerNCT06033001

Expanded Access Treatment with [Lu-177]-PNT2002 for Adult Patients with Prostate-Specific Membrane Antigen (PSMA)-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC)

A study testing [Lu-177]-PNT2002 in people with Castration-Resistant Prostatic Cancer, run by Lantheus Medical Imaging at 7 sites in United States.

Temporarily Not Available

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this program is to provide access to [Lu-177]-PNT2002 to patients who have been diagnosed with prostate-specific membrane antigen (PMSA)-positive castration-resistant prostate cancer (mCRPC). Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Castration-Resistant Prostatic Cancer
What is being tested?
[Lu-177]-PNT2002
Type of treatment
Injection or infusion
How many people
Not given
Where
7 sitesUnited States
Study dates
Start not givento not given
Phase
Expanded access
Are there results?
None posted in the registry

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
  • Adult, Older adult

Who may be able to join

  • Patient is male aged 18 years or older;
  • Histological, pathological, and/or cytological confirmation of adenocarcinoma of the prostate;
  • Patients must have at least 1 metastatic lesion present on CT, MRI, or bone scan imaging;
  • Patients must have progressive mCRPC based on at least 1 of the following criteria:
  • Serum/plasma PSA progression defined as increase in PSA greater than 25% and >2 ng/mL above nadir, confirmed by progression at 2 time points at least 3 weeks apart
  • Soft-tissue progression defined as an increase ≥20% in the sum of the diameters (SOD) (short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest SOD since treatment started or the appearance of one or a new lesion
Show all 28Show fewer
  • Progression of bone disease defined as the appearance of 2 or more lesions by bone scan
  • Progression on prior treatment with ≥1 ARPI (abiraterone, apalutamide, darolutamide, enzalutamide ) in nmCRPC, mHSPC or mCRPC;
  • PSMA-PET scan ([Ga-68]-PSMA-11 or [F-18]-DCFPyL) positive as determined by local investigator;
  • At least 1 PSMA-PET positive lesion for prostate cancer
  • Uptake greater than the liver will be used as the reference for determining PSMA-PET positivity and uptake less than or equal to the liver will be used as the reference for determining PSMA-PET negativity
  • All lymph nodes that measure ≥25 mm in short axis on anatomic imaging must be PSMA-PET positive
  • All bone metastases with soft tissue component(s) ≥10 mm in short axis must be PSMA-PET positive (PSMA-negative osseous metastases without a soft tissue component do not exclude patients)
  • All solid organ metastases (i.e., lung, liver, adrenal glands, etc.) ≥10 mm in short axis must be PSMA-PET positive
  • Castrate levels of circulating testosterone (<1.7 nmol/L or <50 ng/dL);
  • Patients must have recovered to Grade ≤2 from all clinically significant toxicities related to; prior therapies (i.e., prior ARPI, chemotherapy, PARPi, radioisotope or immunotherapy, etc.)
  • Adequate organ function, independent of transfusion;
  • Bone marrow reserve
  • White blood cell (WBC) count ≥2.5 x 109/L OR absolute neutrophil count (ANC) ≥1.5 x 109/L ii. Platelets ≥100 x 109/L iii. Hemoglobin ≥80 g/L or ≥8 g/dL
  • Liver function
  • Total bilirubin ≤1.5 x institutional upper limit of normal (ULN). For patients with known Gilbert's syndrome, ≤3.0 x ULN ii. ALT and AST ≤3.0 x ULN
  • Renal function
  • Creatinine clearance ≥50 mL/min based on Cockroft-Gault formula
  • Albumin ≥30 g/L
  • Human immunodeficiency virus-infected patients who are healthy and have a low risk of acquired immunodeficiency syndrome-related outcomes are eligible;
  • ECOG performance status 0 or 1;
  • For patients who have partners who are pregnant or of childbearing potential: a condom is required along with a highly effective contraceptive method during the study and for 6 months after last study drug administration. Such methods deemed highly effective include a) combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation, b) progestogen-only hormonal contraception associated with inhibition of ovulation, c) intrauterine device (IUD), d) intrauterine hormone-releasing system (IUS), e) bilateral tubal occlusion, f) vasectomy, g) true sexual abstinence: when this is in line with the preferred and usual lifestyle of the subject [periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence for the duration of exposure to IMP, and withdrawal are not acceptable methods of abstinence].
  • Signed Informed Consent Form

Who cannot join

  • Prior PSMA-targeted radioligand therapy (i.e., [Lu-177]-PSMA-617);
  • A superscan defined as a bone scan that demonstrates markedly increased skeletal radioisotope uptake relative to soft tissues in association with absent or faint genitourinary tract activity;
  • Patients with a history of central nervous system (CNS) metastases must have received therapy (surgery, radiotherapy, gamma knife) and be neurologically stable, asymptomatic, and not receiving corticosteroids for the purposes of maintaining neurologic integrity;
  • Patients with epidural disease, canal disease and prior cord involvement are eligible if those areas have been treated, are stable, and not neurologically impaired. For patients with parenchymal CNS metastasis (or a history or CNS metastasis), baseline and subsequent radiological imaging must include evaluation of the brain (MRI preferred or CT with contrast);
  • Symptomatic cord compression, or clinical radiologic findings indicative of impending cord compression;
  • Any pre-existing symptoms, or concurrent severe and/or uncontrolled medical conditions such as ureteral obstruction, which in the opinion of the investigator would compromise safe participation in the [Lu-177]-PNT2002 EAP;
  • Not able to understand and comply with treatment instructions and requirements;

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • BAMF Health, Inc

    Grand Rapids, Michigan, 49503

  • John Theurer Cancer Center at Hackensack Meridian University Medical Center

    Hackensack, New Jersey, 07601

  • Hartford HealthCare Cancer Institute at Hartford Hospital

    Hartford, Connecticut, 06106

  • Florida Theranostics Cancer Center

    Jupiter, Florida, 33458

  • Biogenix Molecular, LLC

    Miami, Florida, 33165

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California, 92663

  • Comprehensive Hematology Oncology

    Trinity, Florida, 34655

Other trials in United States

About this study

The purpose of this program is to provide access to [Lu-177]-PNT2002 to patients who have been diagnosed with prostate-specific membrane antigen (PMSA)-positive castration-resistant prostate cancer (mCRPC). Patients must have received at least 1 prior androgen pathway inhibitor (ARPI) and cannot be treated by currently available drugs or clinical trials.

In this program participants will be administered [Lu-177]-PNT2002 intravenously every 8 weeks (about every 2 months) for 4 cycles, or 8 months of total treatment. During treatment, participants will be monitored with routine laboratory tests such as:

  • Hematology blood tests
  • Clinical Chemistry blood tests
  • Testosterone/Prostate Antigen levels blood test
  • Vital signs
  • Imaging
  • ECG
Being tested
[Lu-177]-PNT2002
Keywords
progressive mCRPC
Medical subject headings
Prostatic Neoplasms, Castration-Resistant

What participants receive

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

  • [Lu-177]-PNT2002Drug

    [Lu-177]-PNT2002, is a radiopharmaceutical investigational drug. [Lu-177]-PNT2002 targets a specific protein that is located on the surface of prostate cancer cells called PSMA. [Lu-177]-PNT2002 delivers radiation to your cancer by binding to the PSMA which helps destroy the cancer cells. [Lu-177]-PNT2002 is administered intravenously every 8 weeks (about every 2 months) for 4 cycles, or 8 months of total treatment.

Timeline

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

  1. First posted13 Sep 2023

Resources

More details

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

Study design
Study type
Expanded access
IDs, dates and publications
ClinicalTrials.gov ID
NCT06033001
Sponsor's protocol ID
LNTH-PNT2002-EAP01
Status last verified
Jan 2025
First submitted
10 Aug 2023
Last updated
13 Jan 2025
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing [Lu-177]-PNT2002 in people with Castration-Resistant Prostatic Cancer, run by Lantheus Medical Imaging at 7 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 28 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06033001.

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 13 Jan 2025; AzTrials last refreshed its copy on 7 Nov 2026.

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