A Phase 2 interventional study of Deutenzalutamide and Docetaxel in Prostate Cancer (Adenocarcinoma), sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. Not yet recruiting at 1 site in China. Open to male participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Phase 2, Interventional, and Treatment
This study will assess the effects and safety of deutenzalutamide combined with hormone therapy before and after prostate cancer surgery, with docetaxel chemotherapy added before surgery. It is intended for men with high-risk localized or locally advanced prostate cancer who have no distant spread on imaging and are suitable for surgery.
The researchers will measure how often treatment leaves no cancer or only a very small amount of cancer in the prostate, with no cancer in the pelvic lymph nodes removed during surgery. They will also assess whether participants can undergo the planned surgery, what side effects occur, and whether the cancer returns or spreads during follow-up.
Up to 37 participants will be enrolled at several hospitals. All participants will be assigned to the same treatment plan; there is no comparison group.
The planned treatment includes:
Hormone therapy will continue across the treatment periods for a total of at least 13 months. Treatment may be adjusted or stopped according to side effects and the participant's condition. Follow-up is planned for up to 5 years after all study treatment has ended.
Participants may also choose to join an optional study using a single blood sample collected before treatment and leftover tissue from their diagnostic prostate biopsy. These samples will be used to explore features that may be associated with treatment response and later outcomes. Participation in this optional component is not required to receive the study treatment.
POST-PC-01 is an investigator-initiated, prospective, multicenter, single-arm, open-label exploratory study. The rationale is to combine androgen receptor pathway inhibition and androgen deprivation with chemotherapy before definitive surgery, while limiting docetaxel exposure to the preoperative period. The study will generate preliminary evidence on antitumor activity, safety, and clinical feasibility; it is not designed to establish superiority over another treatment.
The study uses a Simon minimax two-stage design. The first stage includes 16 participants in the prespecified primary efficacy decision analysis set. Enrollment will proceed to the second stage only if the first-stage results meet the predefined continuation criterion. The second stage adds 15 participants, for a total of 31 participants in the decision analysis set. The maximum enrollment of 37 allows limited replacement under protocol-defined circumstances unrelated to treatment efficacy or tolerability. Participants unable to undergo surgery because of disease progression or treatment toxicity are counted as nonresponders rather than replaced.
The optional exploratory component is limited to pretreatment samples. It includes one peripheral blood collection of 20 mL for genetic analysis and the use of residual tissue from the diagnostic prostate biopsy. Tissue assessments include intraductal carcinoma of the prostate, BRCA1 and BRCA2 and other DNA repair-related gene alterations, and PTEN deletion or related abnormalities. No additional biopsy is performed for this component.
Where samples and outcome data are available, associations between baseline pathological or genetic features and pathological response, recurrence, or progression will be explored descriptively. Participation requires an affirmative choice within the study informed consent form. Declining or withdrawing from this optional component does not affect participation in the study treatment and follow-up.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's planned enrollment of 37 is below the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University is the lead sponsor of 483 studies on the registry; 283 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
High-risk disease is defined by meeting either (1) or (2):
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.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
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 study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
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 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).
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.
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.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
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.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
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.
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.
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.
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.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
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.
Neoadjuvant treatment: deutenzalutamide 80 mg orally once daily plus androgen deprivation therapy (ADT) for 24 weeks, with docetaxel 60 mg/m2 intravenously every 3 weeks for 6 cycles. Prednisone acetate 5 mg orally twice daily is given during docetaxel treatment, with subsequent tapering/discontinuation according to the protocol. When medically appropriate, participants undergo radical prostatectomy with pelvic lymph node dissection approximately 2 weeks after neoadjuvant treatment. After adequate postoperative recovery, deutenzalutamide is resumed at the last tolerated dose with ADT for 24 weeks, starting approximately 4 weeks after surgery. No postoperative docetaxel is given. ADT continues throughout for a total of at least 13 months. Dose modifications and treatment interruptions follow the protocol.
Drug: Deutenzalutamide · Drug: Docetaxel · Drug: ADT
Deutenzalutamide 80 mg is administered orally once daily with androgen deprivation therapy (ADT) for 24 weeks before radical prostatectomy. After adequate postoperative recovery, deutenzalutamide is planned to resume approximately 4 weeks after surgery at the last tolerated dose, with ADT, for an additional 24 weeks. Dose modifications and treatment interruptions are managed according to the protocol.
Docetaxel 60 mg/m² is administered by intravenous infusion every 3 weeks for 6 cycles (planned at Weeks 0, 3, 6, 9, 12, and 15) during neoadjuvant treatment, in combination with deutenzalutamide and androgen deprivation therapy (ADT). Treatment interruptions and discontinuation follow protocol-defined criteria; docetaxel is not administered during postoperative adjuvant treatment.
Androgen deprivation therapy (ADT) is administered according to the prescribing information for the selected agent. Treatment begins in the neoadjuvant phase and continues through the perioperative and postoperative adjuvant phases for a total duration of at least 13 months.
Pathological Complete Response or Minimal Residual Disease (pCR/MRD) Rate
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.
Time frame: At postoperative pathological assessment (surgery planned approximately 26 weeks after treatment initiation; qualifying surgery within 56 days after the actual end of neoadjuvant treatment).
Metastasis-Free Survival (MFS)
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.
Time frame: 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.
Event-Free Survival (EFS)
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.
Time frame: 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 to Distant Metastasis
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.
Time frame: 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 to First Subsequent Anticancer Therapy
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.
Time frame: 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.
Biochemical Recurrence-Free Survival (bRFS)
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.
Time frame: From radical prostatectomy to biochemical recurrence or death, whichever occurs first, with follow-up through 60 months after the end of all study treatment.
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
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.
Time frame: From the first dose of protocol-specified anticancer treatment through 30 days after the end of all study treatment.
Percentage of Participants With Grade 3 or Higher Adverse Events
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.
Time frame: From the first dose of protocol-specified anticancer treatment through 30 days after the end of all study treatment.
Percentage of Participants With Serious Adverse Events (SAEs)
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.
Time frame: From the first dose of protocol-specified anticancer treatment through 30 days after the end of all study treatment.
Percentage of Participants With Adverse Events Leading to Study Drug Interruption, Dose Modification, or Permanent Discontinuation
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.
Time frame: From the first dose of protocol-specified anticancer treatment through 30 days after the end of all study treatment.
Percentage of Participants With Treatment-Related Deaths
Percentage of participants in the safety analysis set who die from an adverse event assessed by the investigator as related to study treatment. Related events include those judged definitely, probably, or possibly related to a protocol-specified study intervention; deaths assessed as unlikely related or unrelated are excluded from this endpoint.
Time frame: From the first dose of protocol-specified anticancer treatment through 30 days after the end of all study treatment.
Serum Prostate-Specific Antigen (PSA) Level at the End of Neoadjuvant Treatment
Serum prostate-specific antigen (PSA) concentration is measured in ng/mL at the end of neoadjuvant treatment, before radical prostatectomy. The absolute PSA value at this assessment is summarized using descriptive statistics.
Time frame: At the end of neoadjuvant treatment (planned at Week 24), before radical prostatectomy.
Serum Prostate-Specific Antigen (PSA) Levels After Radical Prostatectomy and During Adjuvant Treatment
Serum prostate-specific antigen (PSA) concentration, expressed in ng/mL, is measured after radical prostatectomy at the adjuvant treatment baseline and at scheduled visits during adjuvant treatment. PSA values are summarized descriptively at each assessment to characterize postoperative PSA dynamics.
Time frame: At adjuvant treatment baseline (approximately 4 weeks after radical prostatectomy) and at adjuvant Weeks 4, 8, 12, 16, 20, and 24/end of treatment.
Pathological Primary Tumor Stage (ypT) After Neoadjuvant Treatment
Pathological primary tumor stage (ypT) is determined by histopathological examination of radical prostatectomy specimens obtained after neoadjuvant treatment. The number and percentage of participants in each ypT category are summarized.
Time frame: At final postoperative pathological assessment following radical prostatectomy (surgery planned approximately 26 weeks after treatment initiation).
Pathological Regional Lymph Node Stage (ypN) After Neoadjuvant Treatment
Pathological regional lymph node stage (ypN) is determined by histopathological examination of pelvic lymph node dissection specimens obtained at radical prostatectomy. The number and percentage of participants in each ypN category are summarized, with unknown or unevaluable nodal status reported separately.
Time frame: At final postoperative pathological assessment following radical prostatectomy (surgery planned approximately 26 weeks after treatment initiation).
Composite Pathological Downstaging Rate (T and/or N)
Percentage of participants with pathological downstaging, assessed by comparing postoperative pathological T and N categories (ypT and ypN) with pretreatment clinical categories (cT and cN). Downstaging requires a lower T category and/or conversion from cN1 to ypN0, with no worsening of either category. Each participant meeting this composite definition is counted once.
Time frame: From pretreatment baseline to final postoperative pathological assessment (surgery planned approximately 26 weeks after treatment initiation).
Positive Surgical Margin Rate
Percentage of participants with a positive surgical margin on final histopathological examination of the radical prostatectomy specimen after neoadjuvant treatment. A positive margin is defined as tumor cells touching the inked resection surface.
Time frame: At final postoperative pathological assessment following radical prostatectomy (surgery planned approximately 26 weeks after treatment initiation).
Objective Response Rate (ORR) at the End of Neoadjuvant Treatment
Objective response rate is the percentage of participants in the full analysis set with measurable disease at baseline who achieve an overall complete or partial response. Response is assessed by imaging according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 at the end of neoadjuvant treatment, before radical prostatectomy.
Time frame: At the end of neoadjuvant treatment (planned at Week 24), before radical prostatectomy.
Radical Prostatectomy Rate
Percentage of participants in the full analysis set who undergo radical prostatectomy following neoadjuvant study treatment. Surgical status is determined from operative records, and reasons for not undergoing surgery are documented.
Time frame: During the surgical phase following neoadjuvant treatment (radical prostatectomy planned approximately 26 weeks after treatment initiation).
Rate of Radical Prostatectomy Delay Due to Treatment-Related Adverse Events
Percentage of participants whose planned radical prostatectomy is delayed because of an adverse event assessed by the investigator as related to study treatment. Related events include those considered definitely, probably, or possibly related; delays solely due to reasons unrelated to study treatment are excluded.
Time frame: From initiation of neoadjuvant treatment through the surgical phase (radical prostatectomy planned approximately 26 weeks after treatment initiation).
Incidence and Severity of Postoperative Complications
Percentage of participants undergoing radical prostatectomy who experience at least one postoperative complication. Complications are summarized by type and severity using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 6.0, with investigator clinical judgment for events not specifically covered by CTCAE.
Time frame: From radical prostatectomy through the adjuvant baseline visit (approximately 4 weeks postoperatively), with additional assessment at adjuvant Week 4 (approximately 8 weeks postoperatively) as clinically indicated.
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drugs tested here: Enzalutamide · Docetaxel
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University →