Trial · NCT07907653
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| 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. |
| Secondary | Percentage of Participants With Treatment-Related Deaths | 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 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. |
| Secondary | Serum Prostate-Specific Antigen (PSA) Level at the End of Neoadjuvant Treatment | At the end of neoadjuvant treatment (planned at Week 24), before radical prostatectomy. | 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. |
| Secondary | Serum Prostate-Specific Antigen (PSA) Levels After Radical Prostatectomy and During Adjuvant Treatment | At adjuvant treatment baseline (approximately 4 weeks after radical prostatectomy) and at adjuvant Weeks 4, 8, 12, 16, 20, and 24/end of 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. |
| Secondary | Pathological Primary Tumor Stage (ypT) After Neoadjuvant Treatment | At final postoperative pathological assessment following radical prostatectomy (surgery planned approximately 26 weeks after treatment initiation). | 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. |
| Secondary | Pathological Regional Lymph Node Stage (ypN) After Neoadjuvant Treatment | At final postoperative pathological assessment following radical prostatectomy (surgery planned approximately 26 weeks after treatment initiation). | 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. |
| Secondary | Composite Pathological Downstaging Rate (T and/or N) | From pretreatment baseline to final postoperative pathological assessment (surgery planned approximately 26 weeks after treatment initiation). | 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. |
| Secondary | Positive Surgical Margin Rate | At final postoperative pathological assessment following radical prostatectomy (surgery planned approximately 26 weeks after treatment initiation). | 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. |
| Secondary | Objective Response Rate (ORR) at the End of Neoadjuvant Treatment | At the end of neoadjuvant treatment (planned at Week 24), before radical prostatectomy. | 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. |
| Secondary | Radical Prostatectomy Rate | During the surgical phase following neoadjuvant treatment (radical prostatectomy planned approximately 26 weeks after treatment initiation). | 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. |
| Secondary | Rate of Radical Prostatectomy Delay Due to Treatment-Related Adverse Events | From initiation of neoadjuvant treatment through the surgical phase (radical prostatectomy planned approximately 26 weeks after treatment initiation). | 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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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