Prostate CancerPhase 3NCT07795268
Study to Evaluate the Efficacy and Safety of 177Lu-NYM032 Injection in Participants With Progressive, PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC)
A Phase 3 study testing 177Lu-NYM032 injection in people with Prostate Cancer, run by Norroy Bioscience Co., LTD.
Trial summary
The primary objective of this study is to compare overall survival (OS) in patients with progressive PSMA-positive mCRPC who receive 177Lu-NYM032 in addition to best supportive/best standard of care versus patients treated with best supportive/best standard of care alone. 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-NYM032 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 31 Aug 2026to 31 Aug 2029
- Phase
- Phase 3
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
- Patient must be male and aged ≥18 years old.
- Patients must have histological, pathological, and/or cytological confirmation of prostate cancer.
- Patient's serum/plasma testosterone level must be at a castrate level (<50 ng/dL or <1.7 nmol/L).
- Participants must have ≥1 metastatic lesion that is present on baseline CT, MRI, or bone scan imaging obtained ≤ 28 days prior to randomization.
- Patients must have progressive mCRPC. Documented progressive mCRPC will be based on at least 1 of the following criteria:
- Serum PSA progression defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week prior. The minimal start value is 2.0 ng/mL.
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- Soft-tissue progression defined [PCWG3-modified RECIST v1.1 (Eisenhauer et al 2009, Scher et al 2016)]
- Progression of bone disease: appearance of 2 or more new bone lesions on bone scan (PCWG3 criteria (Scher et al 2016))
- Patients must have a positive 68Ga-NYM032 PET/CT scan.
- Patients must have an ECOG performance status of 0 to 2.
- Patients must have a life expectancy ≥ 6 months.
- Participants must have been previously treated with at least 1 novel androgen receptor pathway inhibitor (ARPI) (e.g., abiraterone and/or enzalutamide) and at least 1, but no more than 2, previous taxane-based chemotherapy regimens. A taxane-based chemotherapy regimen is defined as a minimum exposure of 2 cycles of a taxane. If a participant has received only 1 taxane-based chemotherapy regimen, the participant is eligible : if the participant is unwilling to receive a second taxane-based chemotherapy regimen or if the participant's physician deems the participant unsuitable to receive a second taxane-based chemotherapy regimen (e.g., frailty assessed by geriatric or health status evaluation, intolerance, etc.).
- Patients must have adequate organ function:
- Bone marrow reserve:
- White blood cell (WBC) count ≥2.5 x 109/L
- Hemoglobin≥ 10.0 g/dL (9 g/dL is equivalent to 90 g/L and 5.59 mmol/L)
- Absolute neutrophil count (ANC) ≥1.5 x 10^9/L (1.5 x 10^9/L is equivalent to 1.5 x 10^3/µL and 1.5 x K/µL and 1.5 x 10^3/cumm and 1500/µL)
- Platelets≥ 100 x 10^9/L (100 x 10^9/L is equivalent to 100 x 10^3/µL and 100 x K/µL and 100 x 10^3/cumm and 100,000/µL)
- Hepatic:
- Total bilirubin ≤1.5 x the institutional upper limit of normal (ULN). For patients with known Gilbert's Syndrome ≤ 3 x ULN is permitted
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤3.0 x ULN OR ≤5.0 x ULN for patients with liver metastases
- Renal:
- Serum creatinine ≤1.5 x ULN and creatinine clearance ≥50 mL/min
- Albumin >3.0 g/dL (3.0 g/dL is equivalent to 30 g/L)
- For patients who have partners of childbearing potential:Partner and/or patient must use a method of birth control with adequate barrier protection, deemed acceptable by the principle investigator during the study and for 6 months after last study drug administration. Patients must not donate sperm during this period.
- Patients must have the ability to understand and sign an approved ICF.
Who cannot join
- Any systemic anti-cancer therapy (e.g. chemotherapy, immunotherapy or biological therapy [including monoclonal antibodies], excluding ARPI therapy;) anticancer device therapy, radiation therapy, or an investigational drug in a clinical study within 4 weeks prior to day of randomization.
- Previous treatment with any of the following within 6 months of randomization: Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, hemi-body irradiation.
- Previous PSMA-targeted radioligand therapy is not allowed.
- 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.
- Symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression.
- Any disease involving the cardiac, respiratory, renal, hepatic, or hematologic organ systems that would significantly interfere with completion of the study or confound the determination of the causality of any adverse events in the study.
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- Severe urinary incontinence, hydronephrosis, severe voiding dysfunction, or other related conditions. Note: Participants with bladder outlet obstruction or urinary incontinence that can be managed with available best standard of care (including urinary pads, drainage, etc.) are eligible for study participation.
- Any toxicity related to prior anti-cancer therapies that has not recovered to ≤ Grade 2 according to NCI CTCAE v6.0, except for alopecia.
- Uncontrolled or clinically significant cardiovascular disease, including but not limited to:
- History of symptomatic congestive heart failure (New York Heart Association [NYHA] Class III to IV) or any arterial thromboembolic events (e.g., myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack) within 6 months prior to randomization;
- Uncontrolled hypertension, defined as systolic blood pressure (SBP) ≥160 mmHg and/or diastolic blood pressure (DBP) ≥100 mmHg despite antihypertensive therapy;
- Serious cardiac arrhythmias requiring treatment;
- Prolonged corrected QT interval using Fridericia' s formula (QTcF) >450 ms (male).
- Clinically significant concomitant pulmonary diseases, including but not limited to:
- History of interstitial lung disease (ILD)/interstitial pneumonia requiring steroid treatment (non-infectious), current ILD/interstitial pneumonia, or suspected ILD/interstitial pneumonia that cannot be ruled out by imaging assessment;
- Pulmonary embolism within 3 months prior to randomization;
- Any documented autoimmune, connective tissue, or inflammatory disease at screening (e.g., rheumatoid arthritis, Sjögren's syndrome, sarcoidosis) with suspected pulmonary involvement;
- Prior pneumonectomy;
- Other moderate to severe pulmonary diseases that significantly impair respiratory function and may interfere with the detection or management of drug-related pulmonary toxicity.
- Severe infection (NCI CTCAE ≥ Grade 3), such as severe pneumonia requiring hospitalization, bacteremia, or infectious complications, within 4 weeks prior to randomization, or active infection requiring systemic anti-infective therapy within 2 weeks prior to randomization. Participants receiving prophylactic anti-infective therapy (e.g., prophylaxis for urinary tract infection or chronic obstructive pulmonary disease exacerbation) may be eligible for enrollment after discussion with the Sponsor.
- A superscan as seen in the baseline bone scan.
- Active bleeding, a history of bleeding disorders, or treatment with coumarin anticoagulants.
- Uncontrolled third-space fluid accumulation (e.g., pleural effusion, ascites, or pericardial effusion) requiring repeated drainage.
- Participants of childbearing potential who are unwilling to use an acceptable method of contraception during the study and for 6 months after the last study drug administration.
- Diagnosed with other malignancies that are expected to alter life expectancy or may interfere with disease assessment. However, patients with a prior history of malignancy that has been adequately treated and who have been disease free for more than 3 years are eligible, as are patients with adequately treated non-melanoma skin cancer, superficial bladder cancer.
- Active chronic hepatitis B infection [e.g., positive hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb) with HBV DNA ≥2,000 IU/mL or ≥5,000 copies/mL], active hepatitis C infection [e.g., positive hepatitis C virus (HCV) antibody with detectable HCV RNA], HIV antibody positivity, or active syphilis infection (positive syphilis-specific antibody and non-treponemal antibody).
- Known hypersensitivity to the components of the study therapy or its analogs.
- Transfusion for the sole purpose of making a subject eligible for study inclusion.
- Any disease, psychiatric condition, or surgical condition that may affect completion of the study (including poor compliance) or render the participant unsuitable for treatment with the investigational medicinal product.
- Any other condition that, in the opinion of the investigator, makes the participant unsuitable for participation in this clinical study.
About this study
Official title: A Phase III, Randomized, Open-Label, Parallel-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of 177Lu-NYM032 Injection in Participants With Progressive, PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC)
The primary objective of this study is to compare overall survival (OS) in patients with progressive PSMA-positive mCRPC who receive 177Lu-NYM032 in addition to best supportive/best standard of care versus patients treated with best supportive/best standard of care alone.
Read the detailed description
Patients with PSMA positive scans will be randomized in a 2:1 ratio to receive either 177Lu-NYM032 plus best supportive/best standard of care or to receive best supportive/best standard of care only. Best supportive/best standard of care will be determined by the treating physician/investigator but will exclude investigational agents, cytotoxic chemotherapy, other systemic radioisotopes, and hemi-body radiotherapy. Novel androgen receptor pathway inhibitor (ARPI) (such as abiraterone or enzalutamide) are allowed.
This open-label study consists of a 12-month enrollment phase and a 24-month follow-up phase. During the whole study period, assessments will include monitoring of patient survival, disease progression, and adverse events.
A long-term follow-up period will include the collection of rPFS survival and information about new treatments, responses to new treatments, adverse events assessment, as well as blood for hematology and chemistry testing. During follow-up, patients will be contacted every 3 months (+/- 14 Days) via phone, email, or letter for 24 months or until 384 deaths have occurred.
An End-of-Treatment (EOT) visit should occur once a participant discontinues study treatment for any reason. This visit should occur within 7 days of the last dose of study treatment or the date the investigator becomes aware of treatment discontinuation (whichever occurs later), but before the initiation of any subsequent anticancer therapy.
A Safety Follow-up visit should occur 28 days (+7 days) after the participant's last dose of 177Lu-NYM032 Injection or the date the investigator becomes aware of treatment discontinuation (whichever occurs later), but before the initiation of any subsequent anticancer therapy outside of what is permitted by the study.
- Conditions
- Prostate Cancer
- Being tested
- 177Lu-NYM032 injection, Best supportive/best standard of care
- 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-NYM032 injectionDrug
Administered intravenously once every 6 weeks (1 cycle) for a maximum of 6 cycles.
Best supportive/best standard of careOther
Best supportive/best standard of care as defined by the local investigator
| Study group | Role | What they receive |
|---|---|---|
| 177Lu-NYM032 plus BSC/BSoC | Experimental | Patients randomized to receive the investigational product will receive 7.4 GBq (+/- 10%) 177Lu-NYM032 intravenously every 6 weeks (+/- 1 week) for a maximum of 6 cycles. Best supportive/best standard of care (BSC/BSoC) may be used. Receives: Drug: 177Lu-NYM032 injection; Other: Best supportive/best standard of care |
| BSC/BSoC alone | Other | Patients randomized to this arm will receive best supportive/best standard of care (BSC/BSoC) as determined by the investigator. Receives: Other: Best supportive/best standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
OS is defined as time to death due to any cause
Measured: From date of randomization until date of death from any cause, assessed up to 36months (estimated final OS analysis)
Secondary outcomes (13)
Radiographic progression-free survival (rPFS)
rPFS is defined as the time to radiographic progression by PCWG3-modified RECIST v1.1 or death
Measured: From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 36 months (estimated final OS analysis)
Number of participants with Treatment Emergent Adverse Events
The distribution of adverse events (AE) will be done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs), Serious Adverse Event (TESAEs) and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters.
Measured: From randomization till 30 days safety follow-up, assessed up to 36 months (estimated final OS analysis)
Overall Response Rate (ORR)
ORR is defined as the proportion of participants with Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) according to PCWG3 modified RECIST 1.1
Measured: From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 36 months (estimated final OS analysis)
Disease control rate (DCR)
DCR is defined as the proportion of participants with Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) in soft tissue according to PCWG3 modified RECIST 1.1
Measured: From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 36 months (estimated final OS analysis)
Duration of Response (DOR)
DOR is defined as the duration of time between the date of first documented response (CR or PR) in soft tissue according to PCWG3 modified RECIST 1.1, and the date of first documented progression or death due to any cause
Measured: From date of randomization until date of progression or date of death from any cause, whichever come first, assessed up to 36 months (estimated final OS analysis)
Time to first Symptomatic Skeletal Event (SSE)
Time to SSE is defined as the date of randomization to the date of first new symptomatic pathological bone fracture, spinal cord compression, tumor-related orthopedic surgical intervention, requirement for radiation therapy to relieve bone pain or death from any cause, whichever occurs first
Measured: From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 36 months (estimated final OS analysis)
Progression-free survival (PFS)
PFS is defined as the time from date of randomization to the date of first documented progression by investigator assessment (radiographic progression, clinical progression, PSA progression) or death from any cause, whichever occurs first
Measured: From date of randomization until date of progression or date of death from any cause, whichever come first, assessed up to 36 months (estimated final OS analysis)
Biochemical response
Biochemical response is defined as the proportion of participants who have a greater or equal 50% decrease in PSA from Baseline that is confirmed by a second PSA measurement 4 weeks later
Measured: From date of randomization till 30 days safety follow-up, assessed up to 36 months (estimated final OS analysis)
Prostate-specific antigen 80 (PSA80) response
PSA80 response is defined as the proportion of participants who have a greater or equal 80% decrease in PSA from Baseline that is confirmed by a second PSA measurement 4 weeks later
Measured: From date of randomization till 30 days safety follow-up, assessed up to 36 months (estimated final OS analysis)
Duration of PSA response
Duration of PSA response is defined as the duration between the date of first document PSA response (i.e. >= 50% decrease in PSA from Baseline) and the earliest date of PSA progression
Measured: From date of randomization till 30 days safety follow-up, assessed up to 36 months (estimated final OS analysis)
European Quality of Life ( EuroQoL) -5 Domain 5 Level Scale (EQ-5D-5L)
EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3=moderate problems, 4= severe problems, and 5= extreme problems. Higher scores indicated greater levels of problems across each of the five dimensions.
Measured: From date of randomization till 30 days safety follow-up, assessed up to 36 months (estimated final OS analysis)
Functional Assessment of Cancer Therapy - Prostate (FACT-P) Questionnaire
FACT-P assesses symptoms/problems related to prostate carcinoma and its treatment. It is a combination of the FACT-General + the Prostate Cancer Subscale (PCS). The FACT-General (FACT-G) is a 27 item Quality of Life (QoL) measure that provides a total score as well as subscale scores: Physical (0-28), Functional (0-28), Social (0-28), and Emotional Well-being (0-24). The total score range is between 1-108, higher scores indicates better for total score and subscale scores. PCS is a 12-item prostate cancer subscale that asks about symptoms and problems specific to prostate cancer (Range 0-48, higher scores better). The FACT-P total score is the sum of all 5 subscale scores of the FACT-P questionnaire and ranges from 0-156. Higher scores indicate higher degree of functioning and better quality of life
Measured: From date of randomization till 30 days safety follow-up, assessed up to 36 months (estimated final OS analysis)
Brief Pain Inventory-short Form (BPI-SF)
The BPI-SF is a publicly available instrument to assess the pain and includes severity and interference scores. BPI-SF is an 11-item self report questionnaire that is designed to assess the severity and impact of pain on daily functions of a participant. Pain severity score is a mean value for BPI-SF questions 3, 4, 5 and 6 (questions inquiring about the extent of pain, where the extent is ranked from 0 [no pain] to 10 [pain as bad as you can imagine]). Pain severity progression is defined as an increase in score of 30% or greater from baseline without decrease in analgesic use
Measured: From date of randomization till 30 days safety follow-up, assessed up to 36 months (estimated final OS analysis)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start31 Aug 2026 (estimated)
- Primary completion30 Nov 2028 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Norroy Bioscience Co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07795268
- Sponsor's protocol ID
- Lu03202
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No