Prostate CancerPhase 3NCT07853209
A Phase 3 Study of [177Lu]Ludotadipep for Metastatic Castration-Resistant Prostate Cancer
A Phase 3 study testing [177-Lu]Ludotadipep in people with Prostate Cancer and mCRPC, run by FutureChem at 8 sites in South Korea.
Trial summary
Primary Efficacy Endpoint Radiographic Progression-Free Survival (rPFS): rPFS is defined as the time from randomization to radiographic disease progression (PD), as assessed by Blinded Independent Central Review (BICR) according to PCWG3-modified RECIST version 1.1, or death from any cause, whichever occurs first. Read more about this study
- Who is it for?
- Ages 19 years and older, men only
- Conditions the study is for
- Prostate Cancer, mCRPC
- What is being tested?
- [177-Lu]Ludotadipep
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 8 sitesSouth Korea
- Study dates
- 26 Jan 2026to 26 Jan 2029
- Phase
- Phase 3
- 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 19 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult male aged ≥19 years at the time of written informed consent.
- Histologically, pathologically, or cytologically confirmed prostate adenocarcinoma without small cell features.
- Patients with progressive metastatic castration-resistant prostate cancer (mCRPC) meeting at least one of the following criteria:
- PSA progression: Minimum PSA level of ≥2.0 ng/mL with at least two consecutive increases at intervals of ≥1 week.
- Soft tissue progression:
- ≥20% increase in the sum of diameters (SOD)* of target lesions compared to the smallest SOD since treatment initiation, or ii. Appearance of one or more new lesions.
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- Short axis for lymph nodes and long axis for non-nodal lesions. (c) Bone progression: Appearance of ≥2 new lesions on bone scan.
- At least one metastatic lesion documented by CT, MRI, or bone scan within 4 weeks prior to baseline.
- Castration-resistant status with serum testosterone ≤50 ng/dL (≤1.7 nmol/L), achieved by surgical or medical castration.
- Patients without bilateral orchiectomy receiving LHRH analogs must continue such therapy throughout the study.
- Prior therapy meeting all of the following:
- At least one novel anti-androgen drug (NAAD) (e.g., enzalutamide and/or abiraterone).
- (First-generation anti-androgens such as bicalutamide, flutamide, and nilutamide are not counted.)
- At least one, but no more than two, prior taxane regimens. Patients who have not received docetaxel may be enrolled if deemed unsuitable, refused treatment, or lack access.
- COG performance status ≤2.
- Life expectancy of at least 24 weeks.
- PSMA-positive mCRPC confirmed by [18F]PSMA PET/CT at screening by independent central review, meeting all of the following:
- At least one PSMA-positive metastatic lesion§.
- §Defined as uptake greater than liver background, regardless of organ system or lesion size.
- No PSMA-negative lesions∥. ∥Defined as metastatic lesions with uptake equal to or lower than liver background and measurable on CT¶.
- i. Bone lesions with soft tissue component ≥1 cm (short axis) ii. Solid organ metastases ≥1 cm (short axis) iii. Lymph nodes ≥2.5 cm (short axis)
- Adequate bone marrow, hepatic, and renal function at screening (one repeat test allowed during screening).
- Agreement to avoid fathering a child and to use effective contraception from screening until 24 weeks after the last dose of study drug, and to refrain from sperm donation.
- Acceptable contraception methods include hormonal contraception, intrauterine device/system, surgical sterilization, double-barrier methods, or complete abstinence.
- Planned best supportive care/standard of care (BSC/SoC) must be permitted in this study, and both investigator and patient agree that disease management with BSC/SoC alone is appropriate.
- Ability to understand the study and provision of written informed consent prior to any study-specific procedures.
Who cannot join
- Prior treatment with any of the following therapies:
- PSMA-targeted radioligand therapy
- Systemic radionuclide therapy within 24 weeks prior to the first dose of study intervention (e.g., strontium-89, samarium-153, rhenium-186, rhenium-188, radium-223, or hemi-body irradiation)
- Any other anticancer therapy (including cytotoxic chemotherapy, immunotherapy, biologic therapy, or targeted therapy) within 4 weeks prior to randomization
- History of any of the following:
- Hypersensitivity to the active substance or any component of the investigation
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- History of another primary malignancy within 3 years prior to screening, except for adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, superficial bladder cancer, papillary thyroid cancer, or carcinoma in situ with no recurrence for at least 2 years, as judged by the investigator
- Clinically significant cardiovascular disease within 24 weeks prior to screening, including but not limited to:
- Myocardial infarction or severe/unstable angina ii. Congestive heart failure (NYHA Class III or IV) iii. QTcF >480 msec on ECG iv. Clinically significant seizures or conditions predisposing to seizures v. Symptomatic or impending spinal cord compression (d) Known human immunodeficiency virus (HIV) infection
- Presence of any of the following comorbidities:
- Uncontrolled hypertension (SBP ≥160 mmHg or DBP ≥90 mmHg)
- Symptomatic or uncontrolled central nervous system metastases (Patients may be eligible if clinically and radiologically stable for ≥4 weeks and off anticonvulsants and corticosteroids for ≥2 weeks prior to study treatment)
- Immunocompromised status (including splenectomy or hematopoietic stem cell transplantation) or active autoimmune disease (e.g., myasthenia gravis, Hashimoto's thyroiditis, rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosus, scleroderma)
- Severe infection or other uncontrolled active infection that may interfere with study assessments, as judged by the investigator
- Active hepatitis B or C infection:
- Hepatitis B: Defined as HBsAg positive at screening; however, patients may be eligible if HBV DNA <500 IU/mL and on stable antiviral therapy for ≥2 weeks prior to first dose, with intent to continue during the study and for ≥24 weeks after the last dose Hepatitis C: Defined as HCV antibody positive; patients are eligible if HCV RNA is negative
- Presence of a superscan on bone scan at baseline.
- Failure to recover to baseline or ≤ Grade 1 from prior anticancer therapy-related toxicities (except for alopecia of any grade or other conditions deemed acceptable per eligibility criteria).
- Participation in another clinical study with administration of an investigational product or device within 4 weeks prior to the first dose of study intervention.
- Any other condition that, in the opinion of the investigator, would make the subject unsuitable for participation in the study.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
South Korea8 sites, 8 recruiting
- Recruiting
National Cancer Center
Gyeonggi-do
Jae Young Joung, 82 1588 8110, urojy@ncc.re.kr
- Recruiting
Ewha Woman University Medical Center
Seoul
Cheong Soo Kim, 82 2 8650 5114, cskim37345806@gmail.com
- Not yet recruiting
Korea University ANAM Hospital
Seoul
Seok Ho Kang, 82 2 1577 0083, mdksh@korea.ac.kr
- Recruiting
Samsung Medical Center
Seoul
Seong Soo Jeon, +82 2 3410 0200, seongsoo.jeon@samsung.com
- Recruiting
Seoul National University Hospital
Seoul
Cheol Kwak, +82 2 1588 5700, mdrafael@snu.ac.kr
- Recruiting
Seoul St. Mary's Hospital
Seoul
Ji Youl Lee, +82 2 1588-1511, uroljy@catholic.ac.kr
- Recruiting
Severance Hospital
Seoul
Seung Hwan Lee, 82 2 1599 1004, LEESEH@yuhs.ac
- Recruiting
St. Vincent's Hospital
Suwon
Seung Ju Lee, 82 1577 8588, lee.seungju@gmail.com
About this study
Official title: A Multi-center, Open-label, Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of [177Lu]Ludotadipep Treatment for Metastatic Castration-resistant Prostate Cancer
Primary Efficacy Endpoint
- Radiographic Progression-Free Survival (rPFS): rPFS is defined as the time from randomization to radiographic disease progression (PD), as assessed by Blinded Independent Central Review (BICR) according to PCWG3-modified RECIST version 1.1, or death from any cause, whichever occurs first. rPFS will be analyzed using the Kaplan-Meier method. The median survival time and corresponding two-sided 95% confidence intervals (CIs) will be estimated for both the investigational and control arms, and Kaplan-Meier curves will be presented.
Read more
A comparison between the investigational and control arms will be performed using a stratified Cox proportional hazards regression model. The model will be adjusted for the following stratification factors: nomogram score (≥178 vs <178), ECOG Performance Status (0 or 1 vs 2), prior use of cabazitaxel before randomization (yes vs no), and receipt of best supportive care alone (yes vs no). The p-value will be reported.
Ties in event times will be handled using the Efron method. The hazard ratio (HR) of the investigational arm relative to the control arm and its corresponding two-sided 95% confidence interval will be provided.
Read the detailed description
Study Procedures:
- Before randomization, investigators determine the most appropriate BSC/SoC for each participant.
- Participants start BSC/SoC from Cycle 1 Day 1 (C1D1). [177-Lu]Ludotadipep is administered every 8 weeks for up to 4 cycles; investigators may allow up to 6 cycles based on clinical judgment. (Participants who do not meet criteria or decline additional [177-Lu]Ludotadipep after 4 cycles will continue BSC/SoC alone.)
- Control arm participants who experience radiographic disease progression may cross over to receive [177-Lu]Ludotadipep in combination with BSC/SoC after obtaining separate consent and confirming eligibility.
- "Cross-over" is defined as [177-Lu]Ludotadipep treatment in the control arm after progression. "Cross-over screening" refers to the eligibility confirmation process for cross-over.
- Conditions
- Prostate Cancer, mCRPC
- Being tested
- [177-Lu]Ludotadipep, Best supportive care/standard of care (BSC/SOC) alone
- Keywords
- Prostatic Neoplasms, Prostatic Diseases, Genital Neoplasms, Male, Urogenital Neoplasms, Male Urogenital Diseases, Neoplasms by Site, Genital Diseases, Urogenital Diseases, Neoplasms
- Medical subject headings
- Prostatic Neoplasms, Prostatic Diseases, Genital Neoplasms, Male, Urogenital Neoplasms, Male Urogenital Diseases, Neoplasms by Site, Genital Diseases, Urogenital Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[177-Lu]LudotadipepDrug
[177-Lu]Ludotadipep 3.7 GBq (+/- 10%) intravenously every 8 weeks for a maximum of 6 cycles.
Best supportive care/standard of care (BSC/SOC) aloneOther
Best supportive care/standard of care as defined by the investigator.
| Study group | Role | What they receive |
|---|---|---|
| [177-Lu]Ludotadipep plus best supportive care/standard of care (BSC/SOC) | Experimental | Each participant will receive 3.7 GBq (+/- 10%) [177-Lu]Ludotadipep every 8 weeks for a total of 4 cycles, with the possibility of up to 6 cycles based on clinical judgment. Best supportive care/standard of care (BSC/BSOC) might be used. Receives: Drug: [177-Lu]Ludotadipep; Other: Best supportive care/standard of care (BSC/SOC) alone |
| BSC/SoC | Active comparator | Control arms will receive best supportive care/standard of care (BSC/SoC) permitted in the trial, according to the investigator's discretion and the standard practices of the study site. Receives: Other: Best supportive care/standard of care (BSC/SOC) alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic Progression-Free Survival (rPFS)
Radiographic progression-free survival (rPFS) is defined as the time from the date of randomization to the date of first documented radiographic disease progression or death from any cause, whichever occurs first, as assessed by blinded independent central review (BICR) according to PCWG3-modified RECIST version 1.1.
Median rPFS and two-sided 95% confidence intervals (CIs) for each treatment group will be estimated using the Kaplan-Meier method, and Kaplan-Meier curves will be presented.
Treatment groups will be compared using a stratified Cox proportional hazards regression analysis, adjusting for stratification factors (nomogram score [>178 vs. ≤178], ECOG performance status [0-1 vs. 2], prior cabazitaxel use, and best supportive care alone). Ties will be handled using the Efron method. The hazard ratio (HR) for the treatment group relative to the control group, along with its two-sided 95% CI and corresponding p-value, will be reported.
Measured: up to 36 months.
Secondary outcomes (11)
Radiographic Progression-Free Survival (rPFS)
Radiographic progression-free survival (rPFS) is defined as the Time from the date of randomization to the date of first documented radiographic disease progression or death from any cause, whichever occurs first, as assessed by blinded independent central review (BICR) and investigator according to RECIST version 1.1 and RECIP 1.0(RECIP BICR Only).
Median rPFS and two-sided 95% confidence intervals (CIs) for each treatment group will be estimated using the Kaplan-Meier method, and Kaplan-Meier curves will be presented.
Treatment groups will be compared using a stratified Cox proportional hazards regression analysis, adjusting for stratification factors (nomogram score [>178 vs. ≤178], ECOG performance status [0-1 vs. 2], prior cabazitaxel use, and best supportive care alone). Ties will be handled using the Efron method. The hazard ratio (HR) for the treatment group relative to the control group, along with its two-sided 95% CI and corresponding p-value, will be reported.
Measured: up to 36 months.
Overall Survival (OS)
Overall survival (OS) is defined as the time from the date of randomization to the date of death from any cause.
Median OS and two-sided 95% confidence intervals (CIs) for each treatment group will be estimated using the Kaplan-Meier method, and Kaplan-Meier curves will be presented.
Treatment groups will be compared using a stratified Cox proportional hazards regression analysis, adjusting for stratification factors (nomogram score [>178 vs. ≤178], ECOG performance status [0-1 vs. 2], prior cabazitaxel use, and best supportive care alone). Ties will be handled using the Efron method. The hazard ratio (HR) for the treatment group relative to the control group, along with its two-sided 95% CI and corresponding p-value, will be reported.
Measured: up to 36 months.
Duration of Response (DOR)
Duration of response (DOR) is defined as the time from the date of first documented partial response (PR) or complete response (CR) to the date of first documented radiographic disease progression (PD), as assessed by blinded independent central review (BICR) and investigator according to RECIST v1.1, PCWG3-modified RECIST v1.1, and RECIP 1.0 (RECIP BICR only).
Median DOR and two-sided 95% confidence intervals (CIs) for each treatment group will be estimated using the Kaplan-Meier method, and Kaplan-Meier curves will be presented.
Treatment groups will be compared using a stratified Cox proportional hazards regression analysis, adjusting for stratification factors (nomogram score [>178 vs. ≤178], ECOG performance status [0-1 vs. 2], prior cabazitaxel use, and best supportive care alone). Ties will be handled using the Efron method. The hazard ratio (HR) for the treatment group relative to the control group, along with its two-sided 95% CI and corresponding p-value, will be reported.
Measured: up to 36 months.
Progression-Free Survival (PFS)
Progression-free survival (PFS) is defined as the time from the date of randomization to the date of first documented radiographic progression, PSA progression, clinical progression, or death from any cause, whichever occurs first, as assessed by investigator according to RECIST v1.1 and PCWG3-modified RECIST v1.1.
Median PFS and two-sided 95% confidence intervals (CIs) for each treatment group will be estimated using the Kaplan-Meier method, and Kaplan-Meier curves will be presented.
Treatment groups will be compared using a stratified Cox proportional hazards regression analysis, adjusting for stratification factors (nomogram score [>178 vs. ≤178], ECOG performance status [0-1 vs. 2], prior cabazitaxel use, and best supportive care alone). Ties will be handled using the Efron method. The hazard ratio (HR) for the treatment group relative to the control group, along with its two-sided 95% CI and corresponding p-value, will be reported.
Measured: up to 36 months.
Objective Response Rate (ORR)
Objective response rate (ORR) is defined as the proportion (%) of participants who achieve a best overall response of complete response (CR) or partial response (PR), as assessed by BICR and investigator according to RECIST v1.1, PCWG3-modified RECIST v1.1, and RECIP 1.0 (RECIP 1.0 assessed by BICR only).
Frequencies, percentages, and two-sided 95% CIs will be presented for each treatment group. Between-group comparisons will be performed using a stratified logistic regression model, adjusting for stratification factors (nomogram score [>178 vs. ≤178], ECOG performance status [0-1 vs. 2], prior cabazitaxel use, and best supportive care alone). The odds ratio (OR) for the treatment group relative to the control group, along with its two-sided 95% CI and corresponding p-value, will be reported.
Measured: up to 36 months.
Health-Related Quality of Life (HRQoL) - BPI-SF (Brief Pain Inventory - Short Form)
Evaluated using Brief Pain Inventory - Short Form (BPI-SF). Pain severity items range from 0 (no pain) to 10 (pain as bad as you can imagine), calculated as the mean of 4 items. Pain interference items range from 0 (does not interfere) to 10 (completely interferes), calculated as the mean of 7 items. Lower scores represent less pain and interference (better outcome); higher scores represent greater pain and interference (worse outcome).
Summary statistics (N, mean, SD, median, min, max) for baseline and post-baseline will be reported. Between-group comparisons will be analyzed using Analysis of Covariance (ANCOVA) on change from baseline, with treatment group as a fixed effect, and baseline score and stratification factors (nomogram score, ECOG PS, prior cabazitaxel use, BSC alone) as covariates. LSM, SE, LSM differences with 95% CIs, and p-values will be reported.
Measured: Baseline and Day 1 of each cycle during treatment
Biochemical Response - Best PSA Response Rate (best PSA-RR)
Best prostate-specific antigen response rate (best PSA-RR) is defined as the proportion (%) of subjects with a ≥50% reduction in Prostate-Specific Antigen (PSA) levels from baseline.
Frequencies and percentages for each treatment group will be presented. Between-group comparisons will be performed using a stratified logistic regression model, adjusting for stratification factors (nomogram score [>178 vs. ≤178], ECOG performance status [0-1 vs. 2], prior cabazitaxel use, and best supportive care alone). The odds ratio (OR) for the treatment group relative to the control group, along with its two-sided 95% confidence interval (CI) and corresponding p-value, will be reported.
Measured: Up to 36 months
Health-Related Quality of Life (HRQoL) - FACT-P (Functional Assessment of Cancer Therapy - Prostate)
Evaluated using Functional Assessment of Cancer Therapy - Prostate (FACT-P) total score (27-item FACT-General plus 12-item Prostate Cancer Subscale). Total scores range from 0 to 156, with higher scores indicating better quality of life. Questionnaire is completed prior to IP administration on Day 1 of each cycle.
Summary statistics (N, mean, SD, median, min, max) for baseline and post-baseline will be reported. Between-group comparisons will be analyzed using ANCOVA on change from baseline, with treatment group as a fixed effect, and baseline score and stratification factors (nomogram score [>178 vs. ≤178], ECOG PS [0-1 vs. 2], prior cabazitaxel use, and best supportive care alone) as covariates. LSM, SE, LSM differences with 95% CIs, and p-values will be reported.
Measured: Baseline and Day 1 of each cycle during treatment
Biochemical Response - Changes in LDH (Lactate Dehydrogenase)
Evaluated by the change from baseline in serum lactate dehydrogenase (LDH) level at specified time points.
Summary statistics (N, mean, SD, median, min, max) for baseline and post-baseline will be reported. Between-group comparisons will be analyzed using ANCOVA on change from baseline, with treatment group as a fixed effect, and baseline LDH level and stratification factors (nomogram score [>178 vs. ≤178], ECOG PS [0-1 vs. 2], prior cabazitaxel use, and best supportive care alone) as covariates. LSM, SE, LSM differences with 95% CIs, and p-values will be reported.
Measured: Baseline and scheduled study visits up to 36 months
Biochemical Response - Changes in ALP (Alkaline Phosphatase)
Evaluated by the change from baseline in serum alkaline phosphatase (ALP) level at specified time points.
Summary statistics (N, mean, SD, median, min, max) for baseline and post-baseline will be reported. Between-group comparisons will be analyzed using ANCOVA on change from baseline, with treatment group as a fixed effect, and baseline ALP level and stratification factors (nomogram score [>178 vs. ≤178], ECOG PS [0-1 vs. 2], prior cabazitaxel use, and best supportive care alone) as covariates. LSM, SE, LSM differences with 95% CIs, and p-values will be reported.
Measured: Baseline and scheduled study visits up to 36 months
Disease Control Rate (DCR)
Disease Control Rate (DCR) is defined as the proportion (%) of subjects who achieved Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Assessments are performed according to RECIST v1.1, PCWG3-modified RECIST v1.1, and RECIP 1.0 by both Independent Central Review (BICR) and Investigator, except for RECIP 1.0 which is evaluated by BICR only.
Frequencies, percentages, and two-sided 95% confidence intervals (CIs) for each treatment group will be presented. Between-group comparisons will be performed using a stratified logistic regression model, adjusting for stratification factors (nomogram score [>178 vs. ≤178], ECOG PS [0-1 vs. 2], prior cabazitaxel use, and best supportive care alone). The odds ratio (OR) for the treatment group relative to the control group, along with its two-sided 95% CI and corresponding p-value, will be reported.
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start26 Jan 2026
- Primary completion26 Mar 2028 (estimated)
- Study completion26 Jan 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
- Crossover
- Model description
- In this study, administration of \[177-Lu\]Ludotadipep to control arm subjects will be defined as "cross-over." Subjects who undergo cross-over will be referred to as the "cross-over group," and the eligibility assessment process for cross-over will be defined as "cross-over screening." The first dose of \[177-Lu\]Ludotadipep must be administered within 4 weeks after completion of cross-over screening. After initiation of cross-over treatment with \[177-Lu\]Ludotadipep, subjects in the cross-over group may switch to alternative BSC/SoC at any time based on the investigator's clinical judgment. All procedures and assessments following the first cross-over dose will be conducted in accordance with those specified for the investigational treatment arm.
- Masking
- None (open label)
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FutureChem
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ji Youl Lee, Principal investigator, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07853209
- Sponsor's protocol ID
- FC705-3
- Status last verified
- Sep 2026
- First submitted
- 15 Apr 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Open-label, Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of [177Lu]Ludotadipep Treatment for Metastatic Castration-resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT07853209
- Acronym / sponsor ID
- FC705-3
- Conditions
- Prostate Cancer, mCRPC
- Keywords
- Prostatic Neoplasms, Prostatic Diseases, Genital Neoplasms, Male, Urogenital Neoplasms, Male Urogenital Diseases, Neoplasms by Site, Genital Diseases, Urogenital Diseases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- FutureChemIndustry (pharma, biotech, devices)
- Study start
- 26 Jan 2026 (actual)
- Primary completion
- 26 Mar 2028 (estimated)
- Study completion
- 26 Jan 2029 (estimated)
- First posted
- 1 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Efficacy Endpoint
- Radiographic Progression-Free Survival (rPFS): rPFS is defined as the time from randomization to radiographic disease progression (PD), as assessed by Blinded Independent Central Review (BICR) according to PCWG3-modified RECIST version 1.1, or death from any cause, whichever occurs first. rPFS will be analyzed using the Kaplan-Meier method. The median survival time and corresponding two-sided 95% confidence intervals (CIs) will be estimated for both the investigational and control arms, and Kaplan-Meier curves will be presented.
A comparison between the investigational and control arms will be performed using a stratified Cox proportional hazards regression model. The model will be adjusted for the following stratification factors: nomogram score (≥178 vs <178), ECOG Performance Status (0 or 1 vs 2), prior use of cabazitaxel before randomization (yes vs no), and receipt of best supportive care alone (yes vs no). The p-value will be reported.
Ties in event times will be handled using the Efron method. The hazard ratio (HR) of the investigational arm relative to the control arm and its corresponding two-sided 95% confidence interval will be provided.
Detailed description
Study Procedures:
- Before randomization, investigators determine the most appropriate BSC/SoC for each participant.
- Participants start BSC/SoC from Cycle 1 Day 1 (C1D1). [177-Lu]Ludotadipep is administered every 8 weeks for up to 4 cycles; investigators may allow up to 6 cycles based on clinical judgment. (Participants who do not meet criteria or decline additional [177-Lu]Ludotadipep after 4 cycles will continue BSC/SoC alone.)
- Control arm participants who experience radiographic disease progression may cross over to receive [177-Lu]Ludotadipep in combination with BSC/SoC after obtaining separate consent and confirming eligibility.
- "Cross-over" is defined as [177-Lu]Ludotadipep treatment in the control arm after progression. "Cross-over screening" refers to the eligibility confirmation process for cross-over.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In this study, administration of [177-Lu]Ludotadipep to control arm subjects will be defined as "cross-over." Subjects who undergo cross-over will be referred to as the "cross-over group," and the eligibility assessment process for cross-over will be defined as "cross-over screening." The first dose of [177-Lu]Ludotadipep must be administered within 4 weeks after completion of cross-over screening. After initiation of cross-over treatment with [177-Lu]Ludotadipep, subjects in the cross-over group may switch to alternative BSC/SoC at any time based on the investigator's clinical judgment. All procedures and assessments following the first cross-over dose will be conducted in accordance with those specified for the investigational treatment arm.
| Arm | Type | Receives |
|---|---|---|
| [177-Lu]Ludotadipep plus best supportive care/standard of care (BSC/SOC) | Experimental | Drug: [177-Lu]Ludotadipep, Other: Best supportive care/standard of care (BSC/SOC) aloneEach participant will receive 3.7 GBq (+/- 10%) [177-Lu]Ludotadipep every 8 weeks for a total of 4 cycles, with the possibility of up to 6 cycles based on clinical judgment. Best supportive care/standard of care (BSC/BSOC) might be used. |
| BSC/SoC | Active comparator | Other: Best supportive care/standard of care (BSC/SOC) aloneControl arms will receive best supportive care/standard of care (BSC/SoC) permitted in the trial, according to the investigator's discretion and the standard practices of the study site. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Adult male aged ≥19 years at the time of written informed consent.
- Histologically, pathologically, or cytologically confirmed prostate adenocarcinoma without small cell features.
- Patients with progressive metastatic castration-resistant prostate cancer (mCRPC) meeting at least one of the following criteria:
- Short axis for lymph nodes and long axis for non-nodal lesions. (c) Bone progression: Appearance of ≥2 new lesions on bone scan.
- At least one metastatic lesion documented by CT, MRI, or bone scan within 4 weeks prior to baseline.
Key exclusion criteria (20 listed)
- Prior treatment with any of the following therapies:
- History of any of the following:
- Presence of any of the following comorbidities:
- Hepatitis B: Defined as HBsAg positive at screening; however, patients may be eligible if HBV DNA <500 IU/mL and on stable antiviral therapy for ≥2 weeks prior to first dose, with intent to continue during the study and for ≥24 weeks after the last dose Hepatitis C: Defined as HCV antibody positive; patients are eligible if HCV RNA is negative
- Presence of a superscan on bone scan at baseline.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [177-Lu]Ludotadipep[177-Lu]Ludotadipep 3.7 GBq (+/- 10%) intravenously every 8 weeks for a maximum of 6 cycles. | Drug | [177-Lu]Ludotadipep plus best supportive care/standard of care (BSC/SOC) |
| Best supportive care/standard of care (BSC/SOC) aloneBest supportive care/standard of care as defined by the investigator. | Other | BSC/SoC, [177-Lu]Ludotadipep plus best supportive care/standard of care (BSC/SOC) |
Primary outcome
Radiographic Progression-Free Survival (rPFS)
Time frame: up to 36 months.
Radiographic progression-free survival (rPFS) is defined as the time from the date of randomization to the date of first documented radiographic disease progression or death from any cause, whichever occurs first, as assessed by blinded independent central review (BICR) according to PCWG3-modified RECIST version 1.1. Median rPFS and two-sided 95% confidence intervals (CIs) for each treatment group will be estimated using the Kaplan-Meier method, and Kaplan-Meier curves will be presented. Treatment groups will be compared using a stratified Cox proportional hazards regression analysis, adjusting for stratification factors (nomogram score [>178 vs. ≤178], ECOG performance status [0-1 vs. 2], prior cabazitaxel use, and best supportive care alone). Ties will be handled using the Efron method. The hazard ratio (HR) for the treatment group relative to the control group, along with its two-sided 95% CI and corresponding p-value, will be reported.
11 secondary outcomes
Radiographic Progression-Free Survival (rPFS)
Time frame: up to 36 months.
Overall Survival (OS)
Time frame: up to 36 months.
Duration of Response (DOR)
Time frame: up to 36 months.
Progression-Free Survival (PFS)
Time frame: up to 36 months.
Objective Response Rate (ORR)
Time frame: up to 36 months.
Health-Related Quality of Life (HRQoL) - BPI-SF (Brief Pain Inventory - Short Form)
Time frame: Baseline and Day 1 of each cycle during treatment
Biochemical Response - Best PSA Response Rate (best PSA-RR)
Time frame: Up to 36 months
Health-Related Quality of Life (HRQoL) - FACT-P (Functional Assessment of Cancer Therapy - Prostate)
Time frame: Baseline and Day 1 of each cycle during treatment
Biochemical Response - Changes in LDH (Lactate Dehydrogenase)
Time frame: Baseline and scheduled study visits up to 36 months
Biochemical Response - Changes in ALP (Alkaline Phosphatase)
Time frame: Baseline and scheduled study visits up to 36 months
Disease Control Rate (DCR)
Time frame: Up to 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ji Youl Lee principal investigator
Seoul St. Mary's Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing [177-Lu]Ludotadipep in people with Prostate Cancer and mCRPC, run by FutureChem at 8 sites in South Korea.
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 26 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in South Korea. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Chan Soo Park (+82 70 5066 2479, chansoo.park@futurechem.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic Progression-Free Survival (rPFS) (time frame: up to 36 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Oct 2026.