AzTrials
AzTrials

Metastatic Castration-resistant Prostate Cancer, mCRPCPhase 2LUCIDA_2NCT05579184

[Lu-177]Ludotadipep in Castration-resistant Prostate Cancer(CRPC): Investigation of Drug and Application_2

A Phase 2 study testing [177Lu]Ludotadipep in people with Metastatic Castration-resistant Prostate Cancer, mCRPC, run by FutureChem at 1 site in South Korea.

Unknown status

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 The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

100 mCi of [177Lu]Ludotadipep, the dose determined in the phase 1 clinical trial (FC705-1), was administered repeatedly up to 6 times at intervals of 8 weeks (±2 weeks) to patients with metastatic castration resistant prostate cancer (mCRPC) in order to assess the safety and efficacy. Read more about this study

Who is it for?
Ages 19 years and older, men only
What is being tested?
[177Lu]Ludotadipep
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteSouth Korea
Study dates
30 Oct 2022to 31 Dec 2024
Phase
Phase 2
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 19 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult male over the age of 19 as of the date of written consent
  • Adenocarcinoma confirmed by histopathology or cytology
  • Those who have been confirmed with at least two metastases in the soft tissue lesions or bone lesions based on the PCWG3 modified RECIST v1.1 criterion for prostate adenocarcinoma, or those who experience pain due to radiologically apparent disease progression
  • Those with castration resistance with a blood testosterone level of 50 ng/dL or less at the time of screening and those who meet one or more of the criteria below
  • Prostate cancer patients with resistance against imaging-based progression of metastatic castration even after at least 4 weeks of imaging-based progression of standard medical treatment using one or more second-generation hormonal agents (e.g., enzalutamide, abiraterone) are administered in combination with standard taxene-based chemotherapy (e.g., docetaxel).
  • In cases where the patient is judged unsuitable by the investigator for the standard medical treatment specified above
Show all 15Show fewer
  • In cases where the patient himself/herself refuses the standard medical treatment specified above
  • Those that exhibit lesions of 4 or higher PSMA reporting and data system (P-RADS) in the [18F] PSMA PET/CT imaging at the time of screening
  • Those that exhibit higher or wider uptake of the lesion in [18F] PSMA PET/CT imaging than [18F] FDG PET taken at the time of screening as judged by the investigator
  • Those who exhibit an ECOG performance score of level 2 or less at the time of screening and with an expected survival period of at least 6 months
  • Subjects having active sexual activities with a fertile female spouse must satisfy the following:
  • If the spouse is a fertile woman (including pregnant and lactating women), the subject must consent to maintain abstinence or to use double contraception* from the time of screening and throughout the entire clinical trial period and at least 6 months after the administration of the last investigational drug.
  • Sperm of the subject must not be donated during the entire clinical trial period from the time of screening and for at least 6 months after the administration of the last investigational drug.
  • Double contraception: If applicable to at least two of the following: the use of condoms, non-hormonal intrauterine device, diaphragm, cervical cap, if it has been more than 3 months since the male spouse had a vasectomy (at the time of initial screening visit), or the spouse is medically diagnosed with infertility
  • Those who have fully understood the purpose, details, and characteristics of the investigational drug from the investigator before enrolling in the clinical trial and signed the informed consent form in person or by guardian or legal representative

Who cannot join

  • Those who are judged to have abnormalities in bone marrow, liver, or kidney function as they are in accordance with the results of laboratory tests that satisfy at least one of the following criteria at the time of screening:
  • If ANC is below 1.5 x 109/L
  • If Hemoglobin is below 9.0 g/dL
  • If the platelet count is below 100 x 109/L
  • If total bilirubin exceeds 1.5 times the normal value,
  • If serum albumin is below 2.5 g/dL
Show all 19Show fewer
  • If the glomerular filtration rate (eGFR) is below 50 mL/min
  • Those with one or more of the following diseases at the time of screening
  • Those who correspond to Classification III-IV under the New York Heart Association (NYHA) classification of patients with severe heart failure
  • Patients with uncontrolled hypertension (SBP > 160 mm Hg or DBP > 90 mm Hg)
  • Patients with uncontrolled diabetes (HbA1c > 7.0% or fasting blood sugar > 160 mg/dL)
  • Those with a history of prostate cancer or solid cancer other than radical metastasis limited to bone or soft tissue with basis on prostate cancer or blood cancer including lymphoma within 3 years from the time of screening (However, non-melanoma skin cancer, superficial bladder cancer, thyroid cancer, and intraepithelial carcinoma (carcinoma in situ) that do not require continued treatment as they are treated appropriately and remain disease-free within 2 years from the time of screening)
  • Those who have received radiopharmaceutical treatment or radiotherapy for the target lesion of metastatic prostatic carcinoma within 12 weeks from the time of screening
  • Those with active infection of HIV, HBV, HCV, or VDRL at the time of screening, or those with other uncontrolled active infectious diseases with proteinuria of > 1.0 in protein under the urine protein vs. creatinine ratio
  • Those suffering from one or more disease of the following: Immunosuppressive status (including nephrectomy, hematopoietic stem cell transplantation) and autoimmune disease patients (including severe myasthenia, Hashimoto thyroiditis, rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosus, scleroderma) at the time of screening
  • Those who had participated in a therapeutic clinical trial within 30 days of screening and had been administered or applied with other investigational products or investigational devices.
  • Those with potential hypersensitivity reaction to this investigational product [177Lu] ludotadipep
  • Those with an anamnesis of clinically significant mental illness, alcohol abuse, etc.
  • Those who are judged unsuitable by the investigator to participate in this clinical trial for other miscellaneous reasons or who are judged incompatible with the administration requirements

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • The Catholic University of Korea, Seoul, St, Mary's Hospital, 222, Banpo-daero, Seocho-gu

    Seoul

Other trials in South Korea

About this study

Official title: Phase 2 Study of Repeat-dose [177Lu]Ludotadipep Treatment for Metastatic Castration-resistant Prostate Cancer

100 mCi of [177Lu]Ludotadipep, the dose determined in the phase 1 clinical trial (FC705-1), was administered repeatedly up to 6 times at intervals of 8 weeks (±2 weeks) to patients with metastatic castration resistant prostate cancer (mCRPC) in order to assess the safety and efficacy.

Being tested
[177Lu]Ludotadipep
Keywords
prostate cancer
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]LudotadipepDrug

    Patients will receive 100 mCi of [177Lu]Ludotadipep every 8 [±1] weeks (up to 6 times)

    • Test article code/name: [177Lu]Ludotadipep
    • Administration route: intravenous injection
    • Total dose strength: 4 to 6 x 3.7 GBq
    • Dosage form: solution for injection
Study groups in NCT05579184
Study groupRoleWhat they receive
[177Lu]Ludotadipep 100 mCiExperimental100 mCi of [177Lu] ludotadipep shall be administered to the subject repeatedly up to 6 times at intervals of 8 weeks (±2 weeks).
Receives: Drug: [177Lu]Ludotadipep

What is being measured

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

  1. Prostate-Specific Antigen Response Rate (PSA-RR)

    Defined as the proportion of participants with a PSA reduction of ≥ 50% from baseline

    Measured: up to 48 weeks (Response Rate from Baseline to EOT(End of Treatment))

Secondary outcomes (7)

  1. Prostate-Specific Antigen Response Rate (PSA-RR)

    The prostate-specific antigen response rate (PSA-RR) is assessed after the administration of [177Lu]Ludotadipep

    Measured: Between 4 and 6 weeks after treatment

  2. Changes in the Standardized Uptake Values (SUV) of [18F]PSMA PET/CT

    The tumor response is assessed by comparing the changes in the Standardized Uptake Values (SUV) of [18F]PSMA PET/CT after administration of [177Lu]Ludotadipep compared to pre-administration

    Measured: up to 48 weeks (up to 6 doses at 8-weekly intervals [± 1 week], with 6 week follow-up after each dose (Screening up to 28 days)

  3. Objective Response Rate (ORR)

    The objective response rate (ORR) is assessed after administration of [177Lu]Ludotadipep

    Measured: up to 48 weeks (up to 6 doses at 8-weekly intervals [± 1 week], with 6 week follow-up after each dose (Screening up to 28 days)

  4. The Best Objective Response Rate (BORR)

    The best objective response rate (BORR) is assessed after administration of [177Lu]Ludotadipep

    Measured: up to 48 weeks (up to 6 doses at 8-weekly intervals [± 1 week], with 6 week follow-up after each dose (Screening up to 28 days)

  5. Progression-Free Survival (PFS)

    The imaging-based progression-free survival (PFS) is assessed after administration of [177Lu]Ludotadipep

    Measured: up to 48 weeks (up to 6 doses at 8-weekly intervals [± 1 week], with 6 week follow-up after each dose (Screening up to 28 days)

  6. Objective Response Rate (ORR)

    The objective response rate (ORR) is assessed while using PCWG3 modified RECIST V1.1 after administration of [177Lu]Ludotadipep

    Measured: up to 48 weeks (up to 6 doses at 8-weekly intervals [± 1 week], with 6 week follow-up after each dose (Screening up to 28 days)

  7. Pain response rate

    ≥2 point reduction in Present Pain Intensity Scale (PPI) score from baseline with no increase in analgesic score; and/or ≥50% decrease in analgesic score with no increase in PPI using the McGill Questionnaire

    Measured: up to 48 weeks (up to 6 doses at 8-weekly intervals [± 1 week], with 6 week follow-up after each dose (Screening up to 28 days)

Timeline

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

  1. First posted13 Oct 2022
  2. Study start30 Oct 2022
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2024 (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
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05579184
Sponsor's protocol ID
FC705-2
Acronym
LUCIDA_2
Status last verified
Apr 2024
First submitted
6 Oct 2022
Last updated
29 Apr 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing [177Lu]Ludotadipep in people with Metastatic Castration-resistant Prostate Cancer, mCRPC, run by FutureChem at 1 site 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 15 inclusion and 19 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 29 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

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.

What does the primary outcome measure?

Prostate-Specific Antigen Response Rate (PSA-RR) (time frame: up to 48 weeks (Response Rate from Baseline to EOT(End of 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 NCT05579184.

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 29 Apr 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in