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Prostate CancerEarly Phase 1NCT06546527

Study of [177Lu]Lu-PSMA-137 In Metastatic Castrate Resistant Prostate Cancer（mCRPC）

A Early Phase 1 study testing [177Lu]Lu-PSMA-137 in people with Prostate Cancer, run by Peking University First Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This study is a prospective, single-center, single-arm clinical trial consisting of two parts. In Part A, 3 participants were enrolled to receive sequential administrations of low doses of [177Lu]Lu-PSMA-137 and [177Lu]Lu-PSMA-617. 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]Lu-PSMA-137
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
No sites listed yet
Study dates
1 Aug 2024to 1 Dec 2026
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

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

  • Before initiating any assessment process, written informed consent must be obtained from the subject.
  • The participant must be an adult male aged 18 years or older, with an expected lifespan of more than 6 months.
  • The participant must have a confirmed diagnosis of prostate cancer based on histological, pathological, and/or cytological examination.
  • The participant 's [18F]F-PSMA-137 positron emission tomography/computed tomography (PET/CT) scan results must be positive, specifically defined as the presence of prostate specific membrane antigen (PSMA) positive lesions or metastatic lesions with tumor PSMA expression higher than liver parenchyma; no PSMA-negative metastatic lesions: presence of lymph node metastatic lesions with a short diameter of no less than 2.5cm and PSMA concentration lower than liver parenchyma; presence of soft tissue metastatic lesions with a short diameter of no less than 1cm and PSMA concentration lower than liver parenchyma; presence of metastatic bone lesions invading soft tissue, with the soft tissue having a short diameter of no less than 1cm and PSMA concentration lower than liver parenchyma.
  • The participant's serum/plasma testosterone level must be maintained below the castrate level (i.e., <50 ng/dL or <1.7 nmol/L).
  • The participant must have received at least one androgen receptor pathway inhibitors(ARPI) (such as enzalutamide and/or abiraterone) treatment and experienced treatment failure.
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  • The participant must have received at least one but no more than two taxane-based drug treatment regimens and experienced treatment failure; a taxane-based drug treatment regimen is defined as exposure to at least two cycles of taxane drugs. If the participant has only received one taxane-based drug treatment regimen and their doctor assesses that they are unsuitable for a second taxane-based drug treatment regimen due to reasons such as frailty or intolerance, the subject may still be included in the study.
  • The records confirm the progressive mCRPC based on at least one of the following criteria:Serum/plasma prostate specific antigen (PSA) progression is defined as an increase in PSA levels measured in two separate instances at least one week apart, with a minimum starting value of 2.0 ng/mL.Soft tissue progression according to the modified response evaluation criteria in solid tumors version version 1.1 by prostate cancer working group 3 (PCWG3) (Eisenhauer et al., 2009; Scher et al., 2016).Bone disease progression: the presence of two new bone lesions; bone scan positivity alone defines metastatic disease to bone [PCWG3 criteria (Scher et al., 2016)].
  • Prior to enrollment, participant must have had baseline computed tomography (CT), magnetic resonance imaging (MRI), or bone scan imaging obtained within ≤ 21 days, indicating the presence of ≥ 1 metastatic lesion, with at least one measurable lesion as determined by the modified RECIST version 1.1 by PCWG3.
  • Participant must have adequate organ function, including:Bone marrow reserve: white blood cell (WBC) count ≥ 2.5×109/L or absolute neutrophil count (ANC) ≥ 1.5×109/L, platelet count ≥ 100×109/L, and hemoglobin ≥ 9 g/dL.Liver: total bilirubin ≤ 1.5× the upper limit of normal (ULN). For subjects with known Gilbert's syndrome, ≤ 3× ULN is acceptable; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 3.0× ULN or ≤ 5.0× ULN for subjects with liver metastases.
  • Kidney: estimated glomerular filtration rate (eGFR) ≥ 50 mL/min/1.73 m2, calculated using the Modification of Diet in Renal Disease (MDRD) formula.Albumin level: > 3.0 g/dL.
  • ECOG (Eastern Cooperative Oncology Group) performance status score must be 0 - 2.

Who cannot join

  • Within 6 months prior to enrollment, participant who have received radionuclide therapy such as strontium-89, samarium-153, rhenium-186, rhenium-188, radium-223, or hemibody radiotherapy;
  • Participant who have previously received PSMA-targeted radioligand therapy;
  • Participant who require radiotherapy, chemotherapy, immunotherapy, or other anti-tumor treatments within 28 days prior to enrollment or during the trial;
  • Participant who have participated in any other clinical trial within 28 days prior to enrollment;
  • Participant with a history of hypersensitivity to any study drug, its excipients, or drugs of similar chemical classes;
  • Participant with a history of central nervous system (CNS) metastases, neurological instability, symptoms, or requiring glucocorticoids to maintain neurological stability; however, participant with CNS metastases who have received treatment (surgery, radiotherapy, gamma knife, etc.), are asymptomatic with stable neurological function, and are not using corticosteroids are eligible to participate in the study; participant with epidural disease, spinal canal disease, and previously treated areas of spinal cord involvement that are stable and without neurological impairment are also allowed;
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  • Participant with super-bone imaging observed on baseline bone scans;
  • Symptomatic spinal cord compression or clinical or radiological findings suggestive of impending spinal cord compression; A history or current diagnosis of the following electrocardiogram (ECG) abnormalities, indicating significant safety risks for the participant: clinically significant arrhythmias such as sustained ventricular tachycardia, complete left bundle branch block, high-degree atrioventricular block (e.g., bifascicular block, Mobitz type II, and third-degree atrioventricular block); cardiac or cardiac repolarization abnormalities, including any of the following: a history of myocardial infarction (MI), angina, or coronary artery - bypass grafting (CABG) within 6 months prior to signing the informed consent form (ICF);
  • Accompanied by severe (as determined by the principal investigator) medical conditions, including but not limited to new york heart association class III or IV congestive heart failure, a history of congenital long QT syndrome, uncontrolled infection, known active hepatitis B or C, or other significant illnesses that the investigator believes may affect study participation or compliance; subjects with human immunodeficiency virus (HIV) infection at low risk for acquiredImmune deficiency syndrome，(AIDS) related outcomes may participate in this trial;
  • A diagnosis of other malignancies that may alter life expectancy or potentially interfere with disease assessment. Participant with a prior history of malignancy before enrollment, but who have received adequate treatment and have been disease-free and treatment-free for more than 3 years, are eligible to participate in the study, as are participant with adequately treated non-melanoma skin cancer and superficial bladder cancer.
  • Sexually active men were unwilling to use condoms during sexual intercourse during the study treatment period and within 14 weeks after stopping the study treatment. All sexually active male participant must use condoms to prevent their partners from getting pregnant and prevent the transmission of study treatment drugs to their partners through semen. In addition, male participant must not donate sperm within the above-mentioned time frame;
  • With uncontrollable bladder outflow obstruction or urinary incontinence. Note: Participant with bladder outflow obstruction or urinary incontinence are eligible to participate in the study if they can be controlled through the best available standard treatments (including urine pads and drainage);
  • History of physical or mental illness/condition that may interfere with the purpose and evaluation of the study;
  • Any condition that prevents the participant from assuming an arm-raising position.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Xuhe Liao contact

13501381584

13501381584@163.com

About this study

Official title: A Clinical Study Evaluating the Pharmacokinetics, Safety, Tolerability, and Efficacy of [177Lu]Lu-PSMA-137 in Metastatic Castration Resistant Prostate Cancer（mCRPC）

This study is a prospective, single-center, single-arm clinical trial consisting of two parts. In Part A, 3 participants were enrolled to receive sequential administrations of low doses of [177Lu]Lu-PSMA-137 and [177Lu]Lu-PSMA-617. Pharmacokinetics（PK） sampling and single-photon emission computed tomography/computed tomography (SPECT/CT) scans were performed at scheduled time according to the protocol. Based on quantitative pharmacological results, the optimal dosing regimen for [177Lu]Lu-PSMA-137 was derived. In Part B, 3 participants were enrolled to receive treatments with 50% and 100% of the optimal dose of [177Lu]Lu-PSMA-137, to preliminarily evaluate the safety, tolerability, radiation dosimetry, and efficacy of [177Lu]Lu-PSMA-137 in participants with metastatic castration resistant prostate cancer (mCRPC).

Conditions
Prostate Cancer
Being tested
[177Lu]Lu-PSMA-137
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]Lu-PSMA-137Drug

    [177Lu]Lu-PSMA-137 500 MBq;50% optimal dosing;100% optimal dosing

Study groups in NCT06546527
Study groupRoleWhat they receive
[177Lu]Lu-PSMA-137；[177Lu]Lu-PSMA-617Experimental[177Lu]Lu-PSMA-137 500 MBq；[177Lu]Lu-PSMA-617 500 MBq；[177Lu]Lu-PSMA-137 50% optimal dose；[177Lu]Lu-PSMA-137 100% optimal dose；
Receives: Drug: [177Lu]Lu-PSMA-137

What is being measured

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

  1. Incidence of treatment-related adverse events (safety and tolerability)

    Number of participants with treatment-related adverse events as assessed by common terminology criteria for adverse events (CTCAE) version 5.0.

    Measured: From the time of signing informed consent until 42 days after the completion of study treatment

Timeline

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

  1. First posted9 Aug 2024
  2. Study start1 Aug 2024 (estimated)
  3. Primary completion1 Mar 2025 (estimated)
  4. Study completion1 Dec 2026 (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
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06546527
Sponsor's protocol ID
INR102-0-01
Status last verified
Aug 2024
First submitted
1 Aug 2024
Last updated
9 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing [177Lu]Lu-PSMA-137 in people with Prostate Cancer, run by Peking University First Hospital.

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 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: opening soon, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact Xuhe Liao (13501381584, 13501381584@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of treatment-related adverse events (safety and tolerability) (time frame: From the time of signing informed consent until 42 days after the completion of study treatment). 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 NCT06546527.

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 9 Aug 2024.

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