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New treatment option for Prostate Cancer
Official title Phase 1/2 Clinical Study of Lutetium Lu 177 JH020002 Injection in Patients With Advanced Prostate Cancer
ClinicalTrials.gov ID: NCT06139575
What this study is testing
What is Lutetium Lu 177 JH020002 Injection?
Lutetium Lu 177 JH020002 Injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for prostate cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study is being conducted to evaluate the safety, tolerability, pharmacokinetics, radiation dosimetry, and preliminary efficacy of Lutetium Lu 177 JH020002 Injection in adult patients with advanced prostate cancer.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- people are required to get informed consent prior to the trial and sign a written informed consent form voluntarily.
- Male, age ≥18 years.
- ECOG score 0 - 2.
- Must have a life expectancy \>6 months.
- Histologically and/or cytologically confirmed adenocarcinoma of the prostate (except for those with neuroendocrine or small cell prostate cancer...
You likely can't join if
- Diagnosed with other malignancies, apart from: adequately treated skin basal cell carcinoma or superficial bladder cancers from which the patient has...
- Participants with a history of central nervous system (CNS) metastases who are neurologically unstable, symptomatic, or receiving corticosteroids for...
- Previous treatment with Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223 or hemi-body irradiation \<6 months prior to date of first...
- Previous PSMA-targeted radioligand therapy.
- Previous radiotherapy for prostate cancer within 4 weeks prior to date of first administration of investigational drug.
- Any systemic anti-cancer therapy (e.g. chemotherapy, immunotherapy, poly adenosine diphosphate-ribosyl polymerase inhibitors (PARPi) or biological...
See the full eligibility criteria
- people are required to get informed consent prior to the trial and sign a written informed consent form voluntarily.
- Male, age ≥18 years.
- ECOG score 0 - 2.
- Must have a life expectancy \>6 months.
- Histologically and/or cytologically confirmed adenocarcinoma of the prostate (except for those with neuroendocrine or small cell prostate cancer clinical features).
- Participants must have a castrate level of serum/plasma testosterone (\< 50 ng/dl, or \< 1.7nmol/L).
- Diagnosed with other malignancies, apart from: adequately treated skin basal cell carcinoma or superficial bladder cancers from which the patient has been disease-free for more than 3 years as confirmed by a physician.
- Participants with a history of central nervous system (CNS) metastases who are neurologically unstable, symptomatic, or receiving corticosteroids for the purpose of maintaining neurologic integrity.
- Previous treatment with Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223 or hemi-body irradiation \<6 months prior to date of first administration of investigational drug.
- Previous PSMA-targeted radioligand therapy.
- Previous radiotherapy for prostate cancer within 4 weeks prior to date of first administration of investigational drug.
- Any systemic anti-cancer therapy (e.g. chemotherapy, immunotherapy, poly adenosine diphosphate-ribosyl polymerase inhibitors (PARPi) or biological therapy within 4 weeks prior to date of first administration of...
- Must not take part in other investigational therapies within 4 weeks prior to date of first administration of investigational drug.
- History of hypersensitivity to any of the study drugs or its excipients or to drugs of similar chemical classes.
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
- Beijing, Beijing Municipality, China
- Fuzhou, Fujian, China
- Guangzhou, Guangdong, China
- Zhengzhou, Henan, China
- Wuhan, Hubei, China
- Suzhou, Jiangsu, China
- Wuxi, Jiangsu, China
- Jinan, Shandong, China
- Shanghai, Shanghai Municipality, China
- Chengdu, Sichuan, China
- Tianjin, Tianjin Municipality, China
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, China; Beijing, Beijing Municipality, China; Fuzhou, Fujian, China; Guangzhou, Guangdong, China; Zhengzhou, Henan, China; Wuhan, Hubei, China and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.