Docetaxel plus 177Lu-PSMA-I&T in first-line mCRPC

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 is a single-center Phase I open-label trial using a 3+3 dose-escalation design to determine the recommended Phase II dose of docetaxel when combined with a fixed 7.4 GBq dose of 177Lu-PSMA-I&T every 6 weeks. Participants will remain on ongoing androgen deprivation therapy and receive escalating docetaxel doses (50, 60, then 75 mg/m2) every 3 weeks, up to 10 cycles, plus up to 4 cycles of radioligand therapy. The primary endpoint is safety and RP2D; secondary endpoints include DLTs, completion rates, and late toxicities, with exploratory measures such as PSA response, radiographic progression-free survival, and PERCIST-based response. Imaging for dosimetry will be performed after each Lu-177 administration.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Men aged 18 years or older.
2. Histological or cytological diagnosis of prostate adenocarcinoma. The presence of intraductal or cribriform carcinoma will be allowed.
3. Presence of metastatic disease on conventional imaging exams (bone scintigraphy and/or CT scan or MRI).
4. Patients with castration-resistant disease, defined as testosterone \<50 ng/mL in the context of prior orchiectomy or ongoing androgen deprivation therapy (ADT) with LHRH agonists or antagonists, plus at least one of the criteria below:
5. PSA ≥2.0 ng/mL with at least two consecutive PSA rises at intervals of at least 1 week.
6. Radiologic progression defined by the investigator.
7. Clinical progression defined by the investigator.
8. Performance status per the Eastern Cooperative Oncology Group (ECOG) equal to 0 or 1.
9. Willingness to continue ongoing ADT.
10. Adequate organ function as defined below:

    * Parameter Requirement
    * Neutrophils ≥ 1,500/µL
    * Hemoglobin ≥ 12 g/dL
    * Platelets ≥ 100,000/µL
    * Creatinine ≤ 1.5 x upper limit of normal
    * Potassium \> 3.5 mmol/L and \<5.0 mmol/L
    * Total Bilirubin ≤ ULN (unless Gilbert's disease)
    * AST (TGO) ≤ 2.5 x ULN
    * ALT (TGP) ≤ 2.5 x ULN
11. 68Ga-PSMA-PET/CT performed during the screening phase showing metastatic (extraprosthetic and extrapelvic) disease with radiotracer uptake and:
12. SUVmax ≥20 in at least one site;
13. SUVmax \>10 in all other measurable metastatic sites.
14. Lesions with uptake at least 1.5 times greater than hepatic background will be considered measurable.

Exclusion Criteria:

1. Presence of any small-cell or neuroendocrine component of prostate carcinoma.
2. Prior receipt of chemotherapy or radiopharmaceuticals in the castration-resistant setting.
3. Presence of another active malignancy requiring treatment or a cancer diagnosis within the past 5 years. Carcinoma in situ of any site, squamous cell carcinoma of the skin, basal cell carcinoma of the skin, or papillary bladder tumors will be allowed if previously treated.
4. Severe urinary incontinence at the investigator's discretion.
5. 18F-FDG-PET/CT will be performed during screening and will be considered exclusionary if there is discordance with the 68Ga-PSMA-PET/CT. Discordance is defined as FDG-hypermetabolic lesions with absent or low PSMA uptake (SUVmax \<10) in more than 50% of measurable metastatic lesions.
6. Patients with brain metastases visible on 68Ga-PSMA-PET/CT.

Where it's running

• Instituto do Câncer do Estado de São Paulo - ICESP
  São Paulo, Brazil Recruiting

Study contacts

• Principal investigator: José Mauricio Mota, MD, PhD — Medical oncology
• Study coordinator: Research Center, Assistant
• Email: icesp.pesqclinica@hc.fm.usp.br
• Phone: +55 11 3893-3566

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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.