Lu‑177 PSMA‑3D1015 injections for men with metastatic castration‑resistant prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open‑label Phase 1 trial gives intravenous Lu‑177 PSMA‑3D1015 with dosing individualized per participant to optimize safety and exposure. The main goals are to measure safety, tolerability, and radiation dosimetry of the agent, while secondary objectives look for preliminary anti‑tumor activity and help define an optimal dosing regimen. Eligible participants are adult men with histologically confirmed mCRPC, castrate‑level testosterone, PSMA‑positive disease on 68Ga‑PSMA PET/CT, and adequate organ function after prior treatments. Treatment and follow‑up visits are performed at a single center with imaging and lab monitoring to track toxicity and response.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Capable of understanding and providing written informed consent. Willing and able to comply with all study requirements, treatments, and scheduled visits.
2. Male, aged 18 years or older.
3. Histologically or cytologically confirmed prostate adenocarcinoma.
4. Castrate levels of serum/plasma testosterone (\< 50 ng/dL or \< 1.7 nmol/L).
5. Must be 68Ga-PSMA PET/CT scan positive.
6. ECOG performance status of 0 to 2.
7. Confirmed progressive metastatic castration-resistant prostate cancer (mCRPC) that is refractory to or has progressed following prior treatments.
8. Presence of at least one metastatic lesion at baseline.
9. Adequate Organ Function.
10. Resolution of all prior treatment-related toxicities to Grade ≤ 2 (excluding alopecia).

Exclusion Criteria:

1. Receipt of other systemic anti-cancer therapies within 4 weeks prior to study entry.
2. Life expectancy of \< 6 months, as assessed by the investigator.
3. A superscan as seen in the baseline bone scan.
4. Presence of clinically significant, uncontrolled, or unstable concurrent medical conditions that may compromise patient safety or study assessments.
5. Known hypersensitivity or severe intolerance to the study drug, its excipients, or structurally related compounds.
6. Any medical, psychiatric, or logistical condition that, per investigator judgment, would preclude protocol compliance or compromise patient safety.

Where it's running

• Jiangnan University Affiliated Hospital
  Wuxi, Jiangsu, China Recruiting

Study contacts

• Study coordinator: chunjing Yu
• Email: ycjwxd1978@jiangnan.edu.cn
• Phone: 15312238622

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.