A Phase 1 interventional study of Docetaxel 50mg/m2 and Docetaxel 60mg/m2 in Prostate Cancer (Adenocarcinoma), sponsored by Instituto do Cancer do Estado de São Paulo. Recruiting at 1 site in Brazil. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by Instituto do Cancer do Estado de São Paulo · Phase 1, Interventional, and Treatment
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.
This is a Phase I, open-label, single-center study designed to evaluate the safety, tolerability, and to determine the recommended Phase II dose (RP2D) of docetaxel when combined with a fixed dose of 177Lu-PSMA-I\&T in patients with metastatic castration-resistant prostate cancer (mCRPC) who have not previously received chemotherapy for castration-resistant disease.
All participants will continue receiving androgen deprivation therapy (ADT) throughout the study. The treatment regimen includes docetaxel administered intravenously every 3 weeks at escalating doses of 50 mg/m², 60 mg/m², and 75 mg/m² (up to 10 cycles), combined with 177Lu-PSMA-I\&T at a fixed dose of 7.4 GBq every 6 weeks, for up to 4 cycles. A traditional 3+3 dose-escalation design will be used, allowing sequential patient enrollment and assessment of dose-limiting toxicities (DLTs) during the first 3 weeks to establish the optimal docetaxel dose for future studies.
Treatment will continue until completion of 10 cycles of docetaxel and 4 cycles of 177Lu-PSMA-I\&T, or until disease progression, unacceptable toxicity, or withdrawal of consent. Imaging exams, including SPECT, will be performed after each lutetium administration for dosimetry assessment.
The primary endpoint is the determination of the RP2D of docetaxel when combined with 177Lu-PSMA-I\&T. Secondary endpoints include evaluation of the overall safety profile, incidence of DLTs, treatment completion rate, and monitoring of late toxicities. Exploratory endpoints include PSA response (≥50% decline), radiographic progression-free survival (rPFS), and response rate based on PERCIST criteria using PSMA-PET.
Patients will undergo imaging assessments every 6 weeks (±7 days), including PSMA-PET/CT, FDG-PET/CT, CT scans, and bone scintigraphy. Laboratory tests will be performed every 3 weeks during treatment and every 6 weeks during the post-treatment follow-up, for up to 24 weeks.
Key inclusion criteria include: male patients aged 18 years or older, histologically confirmed adenocarcinoma of the prostate, documented metastatic disease by conventional imaging, castration-resistant disease with testosterone levels \<50 ng/mL, ECOG performance status of 0-1, adequate organ function, and positive 68Ga-PSMA-PET/CT uptake according to protocol-defined parameters.
Key exclusion criteria include: presence of small-cell or neuroendocrine tumor components, prior chemotherapy or radiopharmaceuticals for castration-resistant disease, recent or active second malignancies, significant discordance between FDG-PET/CT and PSMA-PET/CT, visible brain metastases, severe urinary incontinence, or any clinical condition that, in the investigator's judgment, would contraindicate the use of docetaxel or 177Lu-PSMA-I\&T. Full details of inclusion and exclusion criteria are provided in the study protocol.
This study aims to establish the optimal dose of docetaxel in combination with 177Lu-PSMA-I\&T and to generate preliminary safety and efficacy data for treating patients with metastatic castration-resistant prostate cancer.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's planned enrollment of 18 is below the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Instituto do Cancer do Estado de São Paulo is the lead sponsor of 91 studies on the registry; 22 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Adequate organ function as defined below:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
Drug page: Docetaxel
Intravenous, 50 mg/m², every 3 weeks, up to 10 cycles
Drug page: Docetaxel
Intravenous, 60 mg/m², every 3 weeks, up to 10 cycles
Drug page: Docetaxel
Intravenous, 75 mg/m², every 3 weeks, up to 10 cycles
Intravenous administration at a fixed dose of 7.4 GBq every 6 weeks, up to 4 cycles.
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.
Time frame: First 3 weeks
Incidence of dose-limiting toxicities (DLTs)
Incidence of dose-limiting toxicities (DLTs)
Time frame: first 3 weeks.
Overall safety profile (CTCAE v5.0)
Overall safety profile (CTCAE v5.0)
Time frame: Up to 24 weeks
Treatment completion rate
Treatment completion rate (≥4 doses of lutetium and ≥7 doses of docetaxel)
Time frame: Up to 24 weeks
Incidence of late toxicities
Incidence of late toxicities
Time frame: Up to 24 weeks post-treatment
PSA50 response rate
PSA50 response rate (≥50% decline from baseline)
Time frame: Up to 24 weeks
Radiographic progression-free survival (rPFS) per PCWG3
Radiographic progression-free survival (rPFS) per PCWG3
Time frame: Up to 12 months
PERCIST-based response rate via PSMA-PET
PERCIST-based response rate via PSMA-PET
Time frame: Up to 12 months
Plan to share: No — It has been decided not to share individual participant data (IPD) related to the study for several reasons. Protecting the privacy of participants is a priority. Sharing IPD may expose sensitive information that, even when de-identified, can be traced back to individuals. Furthermore, the complexity of the data makes sharing challenging without the risk of misunderstandings or misinterpretations, which could compromise the integrity of the research. Sharing IPD without the explicit consent of participants may violate ethical principles of respect and protection. There is also a need to comply with regulatory guidelines governing data sharing to avoid potential legal issues. Finally, the focus will be on disseminating aggregated results that can benefit the scientific community and the public without compromising individual privacy.
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Studies of the drug tested here: Docetaxel
Instituto do Cancer do Estado de São Paulo