A Phase 3 Study of [177Lu]Ludotadipep for Metastatic Castration-Resistant Prostate Cancer

NCT07853209 | Recruiting Phase 3 DMC

• 1 other identifier: FC705-3
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 8

Brief 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. 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.

Conditions

Prostate Cancer; mCRPC

Keywords

Prostatic Neoplasms; Prostatic Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Male Urogenital Diseases; Neoplasms by Site; Genital Diseases; Urogenital Diseases; Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 36 months.

Secondary Outcomes (11)

• Radiographic Progression-Free Survival (rPFS)

  up to 36 months.

• Overall Survival (OS)

  up to 36 months.

• Duration of Response (DOR)

  up to 36 months.

• Progression-Free Survival (PFS)

  up to 36 months.

• Objective Response Rate (ORR)

  up to 36 months.

Study Arms (2)

[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.

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.

Other: Best supportive care/standard of care (BSC/SOC) alone

Interventions

[177-Lu]Ludotadipep DRUG

\[177-Lu\]Ludotadipep 3.7 GBq (+/- 10%) intravenously every 8 weeks for a maximum of 6 cycles.

[177-Lu]Ludotadipep plus best supportive care/standard of care (BSC/SOC)

Best supportive care/standard of care (BSC/SOC) alone OTHER

Best supportive care/standard of care as defined by the investigator.

BSC/SoC; [177-Lu]Ludotadipep plus best supportive care/standard of care (BSC/SOC)

Eligibility Criteria

• Age: 19 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• i. ≥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.
• \*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.

You may not qualify if:

• 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
• 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:
• i. 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:

Sponsors & Collaborators

• FutureChem: lead

Study Sites (8)

National Cancer Center

Gyeonggi-do, South Korea

RECRUITING

Ewha Woman University Medical Center

Seoul, South Korea

RECRUITING

Korea University ANAM Hospital

Seoul, South Korea

NOT YET RECRUITING

Samsung Medical Center

Seoul, South Korea

RECRUITING

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Seoul St. Mary's Hospital

Seoul, South Korea

RECRUITING

Severance Hospital

Seoul, South Korea

RECRUITING

St. Vincent's Hospital

Suwon, South Korea

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Prostatic Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Male Urogenital Diseases; Neoplasms by Site; Genital Diseases; Urogenital Diseases; Neoplasms

Interventions

Single Person

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Intervention Hierarchy (Ancestors)

Marital Status; Family Characteristics; Demography; Population Characteristics; Socioeconomic Factors

Study Officials

• Ji Youl Lee

  Seoul St. Mary's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chan Soo Park

CONTACT

+82 70 5066 2479; chansoo.park@futurechem.co.kr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: October 1, 2026
• Study Start: January 26, 2026
• Primary Completion (Estimated): March 26, 2028
• Study Completion (Estimated): January 26, 2029
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (8)