Trial · NCT07316686
Phase I Study of Docetaxel and 177-Lutetium-PSMA-I&T in First-Line Treatment for Patients With Metastatic Castration-Resistant Prostate Adenocarcinoma
NCT07316686, Phase 1, Recruiting, Instituto do Cancer do Estado de São Paulo
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase I Study of Docetaxel and 177-Lutetium-PSMA-I&T in First-Line Treatment for Patients With Metastatic Castration-Resistant Prostate Adenocarcinoma. Trials, record NCT07316686. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07316686
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase I Study of Docetaxel and 177-Lutetium-PSMA-I&T in First-Line Treatment for Patients With Metastatic Castration-Resistant Prostate Adenocarcinoma
- NCT number
- NCT07316686
- Status
- Recruiting
- Phases
- Phase 1
- Enrollment
- 18 participants, estimated
- Lead sponsor
- Instituto do Cancer do Estado de São Paulo
- Conditions
- Prostate Cancer (Adenocarcinoma)
- Interventions
- Docetaxel 50mg/m2, Docetaxel 60mg/m2, Docetaxel 75 mg/m², 177Lu-PSMA-I&T
- First posted
- 2026-01-05
- Last updated
- 2026-08-25
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Recommended Phase II Dose (RP2D) of docetaxel in combination with 177Lu-PSMA-I&T | First 3 weeks | Determination of the recommended Phase II dose using a standard 3+3 dose-escalation design. |
| Secondary | Incidence of dose-limiting toxicities (DLTs) | first 3 weeks. | Incidence of dose-limiting toxicities (DLTs) |
| Secondary | Overall safety profile (CTCAE v5.0) | Up to 24 weeks | Overall safety profile (CTCAE v5.0) |
| Secondary | Treatment completion rate | Up to 24 weeks | Treatment completion rate (≥4 doses of lutetium and ≥7 doses of docetaxel) |
| Secondary | Incidence of late toxicities | Up to 24 weeks post-treatment | Incidence of late toxicities |
| Other | PSA50 response rate | Up to 24 weeks | PSA50 response rate (≥50% decline from baseline) |
| Other | Radiographic progression-free survival (rPFS) per PCWG3 | Up to 12 months | Radiographic progression-free survival (rPFS) per PCWG3 |
| Other | PERCIST-based response rate via PSMA-PET | Up to 12 months | PERCIST-based response rate via PSMA-PET |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers16
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07316686
GET https://conductscience.org/api/trials/v1/NCT07316686/registered