Trial · NCT07333066
Phase III Randomized International Open Label Clinical Trial of Treatment Intensification With Docetaxel Plus Apalutamide in Patients With Metastatic Hormone-sensitive Prostate Cancer Who Did Not Achieve a Deep PSA Response After Initial Treatment With Apalutamide: REINFORCE Trial.
NCT07333066, Phase 3, Recruiting, Alianza multidisciplinar para la investigación de los tumores genitourinarios -GUARD
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase III Randomized International Open Label Clinical Trial of Treatment Intensification With Docetaxel Plus Apalutamide in Patients With Metastatic Hormone-sensitive Prostate Cancer Who Did Not Achieve a Deep PSA Response After Initial Treatment With Apalutamide: REINFORCE Trial. Trials, record NCT07333066. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07333066
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Phase III Randomized International Open Label Clinical Trial of Treatment Intensification With Docetaxel Plus Apalutamide in Patients With Metastatic Hormone-sensitive Prostate Cancer Who Did Not Achieve a Deep PSA Response After Initial Treatment With Apalutamide: REINFORCE Trial.
- NCT number
- NCT07333066
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 320 participants, estimated
- Lead sponsor
- Alianza multidisciplinar para la investigación de los tumores genitourinarios -GUARD
- Conditions
- Metastatic Hormone-sensitive Prostate Cancer
- Interventions
- Apalutamide (Erleada™) 60 mg or 240 mg tablets, Docetaxel
- First posted
- 2026-01-12
- Last updated
- 2026-06-17
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Event-free Survival (EFS) | 48 months | Event-free survival is defined as the time from randomization to occurrence of the following events, whichever occurs first in each treatment arm: PSA progression or radiographic progression of soft-tissue, visceral, or bone lesions or death from any cause. |
| Secondary | Time to castration resistance | 48 months | Time to castration resistance is defined as time from randomization to radiographic disease progression, PSA progression per PCWG3 criteria, or symptomatic skeletal event (defined as radiation to bone, pathologic fracture, spinal cord compression, or surgery to bone due to symptoms), whichever occurred first in each treatment arm. |
| Secondary | Radiographic progression-free survival (rPFS) | 48 months | Radiographic Progression-Free Survival is defined as the time from randomization to the first documented evidence of radiographic disease progression, as assessed by the investigator per Prostate Cancer Working Group 3 (PCWG3) criteria for bone lesions and RECIST v1.1 for soft tissue lesions, or death from any cause, whichever occurs first in each treatment arm. |
| Secondary | PSA progression-free survival | 48 months | PSA progression-free survival (PSA-PFS) is defined according to PCWG3 criteria as the time from randomization to the date of PSA progression (a ≥25% increase and an absolute increase of ≥2 ng/mL from nadir, confirmed by a second value ≥3 weeks later) or death from any cause, whichever occurs first in each treatment arm. |
| Secondary | Overall survival | 48 months | Overall survival is defined as time from randomization to date of death from any cause in each treatment arm. |
| Secondary | Time to subsequent treatment | 48 months | Time to subsequent treatment is defined as the time from randomization to the initiation of the first subsequent systemic anticancer therapy after study drugs discontinuation, or death, whichever occurs first in each treatment arm. |
| Secondary | Deep PSA response rate at 6 months in each treatment arm. | 6 months | Deep PSA response is defined as achieving a prostate-specific antigen (PSA) level ≤0.2 ng/mL or PSA Response ≥90% in combination with a PSA ≤ 4 ng/ml. |
| Secondary | Ultradeep PSA response rate at 6 months in each treatment arm. | 6 months | Ultradeep PSA response 1 is defined as achieving a prostate-specific antigen (PSA) level between 0.2 and 0.02 ng/mL. Ultradeep PSA response 2 is defined as achieving a prostate-specific antigen (PSA) level ≤ 0.02 ng/mL. |
| Secondary | Symptomatic skeletal event-free survival | 48 months | Symptomatic skeletal event-free survival (SSE-FS) is defined as the time from randomization to the first occurrence of a symptomatic skeletal event (defined as radiation to bone, pathologic fracture, spinal cord compression, or surgery to bone due to symptoms) or death from any cause, whichever occurred first in each treatment arm. |
| Secondary | To evaluate the safety profile of treatment intensification with docetaxel plus apalutamide and ADT (Adverse events) | 25 months | Percentage of patients with at least one adverse event. Toxicity profile will be assessed using the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE), version 5.0. Patients with each adverse event will be calculated over the total number of patients exposed in each treatment arm. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes0
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.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT07333066
GET https://conductscience.org/api/trials/v1/NCT07333066/registered