Phase I Study of Docetaxel and 177-Lutetium-PSMA-I&T in First-Line Treatment for Patients With Me… (NCT07316686) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Phase I Study of Docetaxel and 177-Lutetium-PSMA-I&T in First-Line Treatment for Patients With Metastatic Castration-Resistant Prostate Adenocarcinoma
Brazil18 participantsStarted 2026-01
Plain-language summary
This is a Phase I, open-label, single-center study evaluating the safety, tolerability, and recommended Phase II dose of docetaxel when combined with a fixed dose of 177-Lutetium-PSMA-I\&T in chemotherapy-naïve patients with metastatic castration-resistant prostate cancer (mCRPC). Patients will receive standard androgen deprivation therapy, docetaxel at escalating doses (50 mg/m², 60 mg/m², 75 mg/m² every 3 weeks), and 177Lu-PSMA-I\&T at a fixed dose of 7.4 GBq every 6 weeks (up to 4 cycles). A 3+3 dose escalation design will be employed. Secondary endpoints include safety profile, treatment-limiting toxicities, treatment completion rate, and delayed toxicity. Exploratory endpoints include PSA response, radiographic progression-free survival (rPFS), and PERCIST-based response rate.
Who can participate
Age range18 Years
SexMALE
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Inclusion criteria
✓. Men aged 18 years or older.
✓. Histological or cytological diagnosis of prostate adenocarcinoma. The presence of intraductal or cribriform carcinoma will be allowed.
✓. Presence of metastatic disease on conventional imaging exams (bone scintigraphy and/or CT scan or MRI).
✓. 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:
✓. PSA ≥2.0 ng/mL with at least two consecutive PSA rises at intervals of at least 1 week.
✓. Radiologic progression defined by the investigator.
✓. Clinical progression defined by the investigator.
✓. Performance status per the Eastern Cooperative Oncology Group (ECOG) equal to 0 or 1.
Exclusion criteria
✕. Presence of any small-cell or neuroendocrine component of prostate carcinoma.
What they're measuring
1
Recommended Phase II Dose (RP2D) of docetaxel in combination with 177Lu-PSMA-I&T
Timeframe: First 3 weeks
Trial details
NCT IDNCT07316686
SponsorInstituto do Cancer do Estado de São Paulo
✕. Prior receipt of chemotherapy or radiopharmaceuticals in the castration-resistant setting.
✕. 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.
✕. Severe urinary incontinence at the investigator's discretion.
✕. 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.
✕. Patients with brain metastases visible on 68Ga-PSMA-PET/CT.