Trial · NCT07907653

Deutenzalutamide and Hormone Therapy Before and After Surgery With Docetaxel Before Surgery for High-Risk Localized or Locally Advanced Prostate Cancer

NCT07907653, Phase 2, Not yet recruiting, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Deutenzalutamide and Hormone Therapy Before and After Surgery With Docetaxel Before Surgery for High-Risk Localized or Locally Advanced Prostate Cancer. Trials, record NCT07907653. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07907653

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Deutenzalutamide and Hormone Therapy Before and After Surgery With Docetaxel Before Surgery for High-Risk Localized or Locally Advanced Prostate Cancer
NCT number: NCT07907653
Status: Not yet recruiting
Phases: Phase 2
Enrollment: 37 participants, estimated
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Conditions: Prostate Cancer (Adenocarcinoma)
Interventions: Deutenzalutamide, Docetaxel, ADT
First posted: 2026-10-30
Last updated: 2026-10-30

Source ClinicalTrials.gov

Registered outcomes21

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Pathological Complete Response or Minimal Residual Disease (pCR/MRD) Rate	At postoperative pathological assessment (surgery planned approximately 26 weeks after treatment initiation; qualifying surgery within 56 days after the actual end of neoadjuvant treatment).	Percentage of participants in the prespecified primary efficacy decision analysis set who achieve pCR or MRD on pathological examination of radical prostatectomy and pelvic lymph node dissection specimens after neoadjuvant treatment. pCR is defined as no identifiable residual cancer in the prostate (ypT0) and no regional lymph node metastasis (ypN0). MRD is defined as residual cancer confined to the prostate (ypT2 or lower), with the largest residual tumor focus measuring no more than 5 mm in greatest dimension, and ypN0. Both require no confirmed distant metastasis at assessment. Each participant is counted once. Participants unable to undergo surgery within 56 days after the actual end of neoadjuvant treatment because of disease progression, treatment toxicity or intolerance are counted as nonresponders. Other unassessable cases are handled according to the prespecified protocol rules.
Secondary	Metastasis-Free Survival (MFS)	From the first dose of study anticancer treatment to distant metastasis or death, whichever occurs first, with follow-up through 60 months after the end of all study treatment.	Time from the first administration of study anticancer treatment to the first occurrence of distant metastasis confirmed by imaging (PSMA-PET/CT or conventional imaging) or pathology, or death from any cause, whichever occurs first. Distant metastasis includes nonregional lymph node, bone, or visceral metastasis. Regional pelvic lymph node involvement alone is not considered distant metastasis.
Secondary	Event-Free Survival (EFS)	From the first dose of study anticancer treatment to the first qualifying EFS event, with follow-up through 60 months after the end of all study treatment.	Time from the first dose of study anticancer treatment to the earliest of: (1) biochemical failure after radical prostatectomy (RP), defined as serum prostate-specific antigen (PSA) \>=0.2 ng/mL confirmed by another value \>=0.2 ng/mL at least 1 week later; (2) imaging- or pathology-confirmed local or regional recurrence; (3) imaging- or pathology-confirmed distant metastasis; or (4) death from any cause. The event date for biochemical failure is the date of the first qualifying PSA sample, including for confirmed persistent postoperative PSA. Biochemical failure does not require imaging-confirmed recurrence. Preoperative local or regional progression, including progression preventing RP, is not an EFS event; preoperative distant metastasis or death is an event. Positive surgical margins, positive pathological lymph nodes, or failure to achieve pCR/MRD do not automatically constitute EFS events.
Secondary	Time to Distant Metastasis	From the first dose of study anticancer treatment to the first confirmed distant metastasis, with follow-up through 60 months after the end of all study treatment.	Time from the first dose of study anticancer treatment to the first distant metastasis confirmed by imaging (PSMA-PET/CT or conventional imaging) or pathology. Distant metastasis includes nonregional lymph node, bone, or visceral metastasis. Regional pelvic lymph node involvement alone is not considered distant metastasis. Death without prior distant metastasis is not counted as a distant metastasis event. Competing risks are addressed as prespecified in the statistical analysis plan.
Secondary	Time to First Subsequent Anticancer Therapy	From the first dose of study anticancer treatment to initiation of the first subsequent anticancer therapy, with follow-up through 60 months after the end of all study treatment.	Time from the first dose of study anticancer treatment to the initiation of the first subsequent anticancer therapy outside the protocol-defined treatment regimen for prostate cancer recurrence, progression, or other disease-related reasons. Subsequent therapy may include radiotherapy, endocrine therapy, androgen receptor pathway inhibitors, chemotherapy, radionuclide therapy, or other systemic anticancer treatments. Protocol-specified neoadjuvant and adjuvant treatments are not counted as subsequent therapy. Competing risks are addressed as prespecified in the statistical analysis plan.
Secondary	Biochemical Recurrence-Free Survival (bRFS)	From radical prostatectomy to biochemical recurrence or death, whichever occurs first, with follow-up through 60 months after the end of all study treatment.	Time from radical prostatectomy (RP) to the first occurrence of biochemical recurrence (BCR) or death from any cause, whichever occurs first. BCR is defined as postoperative serum prostate-specific antigen (PSA) \>=0.2 ng/mL, confirmed by a subsequent PSA measurement \>=0.2 ng/mL at least 1 week later. The BCR event date is the date of the first qualifying PSA sample. Participants with persistent postoperative PSA \>=0.2 ng/mL also require subsequent confirmation; the event date is the date of the first postoperative sample meeting this threshold, and PSA persistence is recorded separately. Imaging-confirmed recurrence is not required.
Secondary	Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)	From the first dose of protocol-specified anticancer treatment through 30 days after the end of all study treatment.	Percentage of participants in the safety analysis set who experience at least one treatment-emergent adverse event (TEAE). A TEAE is an adverse event that first occurs or worsens after the first dose of protocol-specified study treatment during the safety observation period, regardless of its relationship to treatment. Events are coded using MedDRA and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 6.0. Severity and relationship to study treatment are summarized. Safety is assessed across the neoadjuvant, surgical, and adjuvant treatment phases.
Secondary	Percentage of Participants With Grade 3 or Higher Adverse Events	From the first dose of protocol-specified anticancer treatment through 30 days after the end of all study treatment.	Percentage of participants in the safety analysis set who experience at least one Grade 3 or higher adverse event during the safety observation period, regardless of its relationship to study treatment. Severity is graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 6.0. Grade 3 indicates severe events, Grade 4 indicates life-threatening events, and Grade 5 indicates death related to an adverse event. Assessment covers the neoadjuvant, surgical, and adjuvant treatment phases.
Secondary	Percentage of Participants With Serious Adverse Events (SAEs)	From the first dose of protocol-specified anticancer treatment through 30 days after the end of all study treatment.	Percentage of participants in the safety analysis set who experience at least one serious adverse event (SAE) during the safety observation period, regardless of its relationship to study treatment. An SAE is an event that results in death, is life-threatening, requires unplanned hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, causes a congenital anomaly or birth defect, or is another important medical event that may jeopardize the participant or require medical or surgical intervention to prevent such outcomes. Planned hospitalization for radical prostatectomy alone is not considered an SAE; complications requiring unplanned admission, readmission, or prolonged hospitalization are assessed against the SAE criteria. Seriousness is assessed separately from NCI-CTCAE severity grading.
Secondary	Percentage of Participants With Adverse Events Leading to Study Drug Interruption, Dose Modification, or Permanent Discontinuation	From the first dose of protocol-specified anticancer treatment through 30 days after the end of all study treatment.	Percentage of participants in the safety analysis set who experience at least one adverse event leading to temporary interruption, dose modification, or permanent discontinuation of a study drug. For each event, the affected drug, action taken, severity, relationship to treatment, and outcome are recorded. Severity is graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 6.0. Assessment covers the neoadjuvant, surgical, and adjuvant treatment phases. Planned treatment completion or protocol-specified interruptions not caused by an adverse event are not counted.

1 to 10 of 21Source ClinicalTrials.gov

See all 21 registered outcomes

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.

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

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