Actively Recruiting
Prospective Clinical Trial of 177Lu-P17-088 in the Treatment of Metastatic Castration-Resistant Prostate Cancer
Led by First Affiliated Hospital of Fujian Medical University · Updated on 2026-05-01
20
Participants Needed
1
Research Sites
139 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
PSMA is an ideal target for precision diagnosis and treatment of prostate cancer. P17-088 is a novel albumin-binding PSMA-targeted radioligand. This study aims to explore the safety and efficacy of 177Lu-labeled P17-088 for treating patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC).
CONDITIONS
Official Title
Prospective Clinical Trial of 177Lu-P17-088 in the Treatment of Metastatic Castration-Resistant Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male patients aged 18 to 90 years
- Diagnosed with metastatic castration-resistant prostate cancer that progresses despite low testosterone levels
- PSA greater than 1 ng/mL with two consecutive rises at least 1 week apart, each rising at least 50% above the lowest point
- Radiographic progression with two or more new bone lesions or soft tissue lesion progression per RECIST 1.1
- Failure, refusal, absence, or refractoriness to standard therapy including at least one but no more than two prior taxane-based therapies
- Progression after receiving at least one novel androgen axis drug (e.g., abiraterone, enzalutamide)
- Ability to understand and sign informed consent and comply with study procedures
- Expected survival greater than 6 months
- ECOG performance status 0 to 2
- Presence of high-uptake lesions on 68Ga-PSMA-11 PET/CT imaging (lesion uptake more than 1.5 times liver background)
- At least one measurable lesion by RECIST 1.1 or at least one bone metastasis per PCWG3 criteria
- Adequate organ function as defined by specific blood test thresholds
- Agreement to follow radiation protection measures during the trial
You will not qualify if you...
- Inability to tolerate imaging procedures
- Receipt of systemic anticancer therapy (excluding endocrine therapy), investigational drugs, or device therapy within 4 weeks prior to dosing
- Receipt of radionuclide therapy within 6 months or external beam radiation therapy within 2 months prior to first dose
- Unresolved Grade 4 or prolonged Grade 3 myelosuppression from prior therapy
- Planned use of cytotoxic chemotherapy, immunotherapy, or radioligand therapy during the study
- Blood product or albumin use within 14 days before dosing
- Brain metastases except specific asymptomatic or treated stable cases
- Other cancers within 5 years except cured localized skin cancers
- Superscan on bone scintigraphy
- Symptomatic or impending spinal cord compression
- Prior extensive bone marrow radiation
- Significant cardiac disease including prolonged QTcF or recent myocardial infarction
- Any condition compromising safety or data integrity per investigator judgment
- Uncontrolled bladder obstruction, urinary incontinence, claustrophobia, or radiophobia
- Positive for HCV, HIV, or syphilis antibodies
- Active HBV infection
- Known allergies to proteins, peptides, or related compounds
- History of drug or alcohol abuse within 1 year or chronic substance abuse
- Failure to use effective contraception during and 6 months after the trial
- Severe active infection prior to first treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China, 350005
Actively Recruiting
Research Team
W
Weibing Miao, MD
CONTACT
G
Guochang Wang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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