Phase I Study of Docetaxel and 177-Lutetium-PSMA-I&T in First-Line Treatment for Patients With Metastatic Castration-Resistant Prostate Adenocarcinoma

NCT07316686 | Not Yet Recruiting Phase 1

• 1 other identifier: NP2028
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer (Adenocarcinoma)

Outcome Measures

Primary Outcomes (1)

• Recommended Phase II Dose (RP2D) of docetaxel in combination with 177Lu-PSMA-I&T

  Determination of the recommended Phase II dose using a standard 3+3 dose-escalation design.

  First 3 weeks

Secondary Outcomes (4)

• Incidence of dose-limiting toxicities (DLTs)

  first 3 weeks.

• Overall safety profile (CTCAE v5.0)

  Up to 24 weeks

• Treatment completion rate

  Up to 24 weeks

• Incidence of late toxicities

  Up to 24 weeks post-treatment

Other Outcomes (3)

• PSA50 response rate

  Up to 24 weeks

• Radiographic progression-free survival (rPFS) per PCWG3

  Up to 12 months

• PERCIST-based response rate via PSMA-PET

  Up to 12 months

Study Arms (3)

Docetaxel 50 mg/m² + 177Lu-PSMA-I&T

EXPERIMENTAL

Patients will receive docetaxel 50 mg/m² IV every 3 weeks plus 177Lu-PSMA-I\&T 7.4 GBq IV every 6 weeks. all patients will continue androgen deprivation therapy.

Drug: Docetaxel 50mg/m2; Radiation: 177Lu-PSMA-I&T

Docetaxel 60 mg/m² + 177Lu-PSMA-I&T

EXPERIMENTAL

Patients will receive docetaxel 60 mg/m² IV every 3 weeks plus 177Lu-PSMA-I\&T 7.4 GBq IV every 6 weeks. all patients will continue androgen deprivation therapy.

Drug: Docetaxel 60mg/m2; Radiation: 177Lu-PSMA-I&T

Docetaxel 75 mg/m² + 177Lu-PSMA-I&T

EXPERIMENTAL

Patients will receive docetaxel 75 mg/m² IV every 3 weeks plus 177Lu-PSMA-I\&T 7.4 GBq IV every 6 weeks. all patients will continue androgen deprivation therapy.

Drug: Docetaxel 75 mg/m²; Radiation: 177Lu-PSMA-I&T

Interventions

Docetaxel 50mg/m2 DRUG

Intravenous, 50 mg/m², every 3 weeks, up to 10 cycles

Docetaxel 50 mg/m² + 177Lu-PSMA-I&T

Docetaxel 60mg/m2 DRUG

Intravenous, 60 mg/m², every 3 weeks, up to 10 cycles

Docetaxel 60 mg/m² + 177Lu-PSMA-I&T

Docetaxel 75 mg/m² DRUG

Intravenous, 75 mg/m², every 3 weeks, up to 10 cycles

Docetaxel 75 mg/m² + 177Lu-PSMA-I&T

177Lu-PSMA-I&T RADIATION

Intravenous administration at a fixed dose of 7.4 GBq every 6 weeks, up to 4 cycles.

Docetaxel 50 mg/m² + 177Lu-PSMA-I&T; Docetaxel 60 mg/m² + 177Lu-PSMA-I&T; Docetaxel 75 mg/m² + 177Lu-PSMA-I&T

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Willingness to continue ongoing ADT.
• 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

You may not qualify if:

• Presence of any small-cell or neuroendocrine component of prostate carcinoma.
• 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.
• Patients with brain metastases visible on 68Ga-PSMA-PET/CT.

Sponsors & Collaborators

• Instituto do Cancer do Estado de São Paulo: lead

Study Sites (1)

Instituto do Câncer do Estado de São Paulo - ICESP

São Paulo, São Paulo, 01246000, Brazil

Location

Related Publications (17)

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MeSH Terms

Conditions

Prostatic Neoplasms; Adenocarcinoma

Interventions

Docetaxel

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Carlos A Buchpiguel, MD, PhD

  Full Professor, Department of Radiology and Oncology

  STUDY DIRECTOR

• José Mauricio Mota, MD, PhD

  Medical oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Research Center, Assistant

CONTACT

+55 11 3893-3566; icesp.pesqclinica@hc.fm.usp.br

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A classic 3+3 dose-escalation design will be used to sequentially assign participants to escalating dose levels of docetaxel combined with fixed-dose 177Lu-PSMA-I\&T.

Study Record Dates

• First Submitted: September 26, 2025
• First Posted: January 5, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 5, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)