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The Efficacy and Safety of Prostatectomy for Castration-Naive Oligometastatic Prostate Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE2

The Efficacy and Safety of Prostatectomy for Castration-Naive Oligometastatic Prostate Cancer

A Randomized, Controlled, Multi-Center Clinical Trial to Evaluate the Efficacy and Safety of Prostatectomy for Castration-Naive Oligometastatic Prostate Cancer

NCT04992026•The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

View on ClinicalTrials.gov

Summary

This randomized, controlled, multi-center clinical trial aims to evaluate the efficacy and safety of prostatectomy for castration-Naive oligometastatic prostate cancer

Eligibility

Age

40 - 75 years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Patients must be ≥ 40 and ≤75 years of age.
•All patients must have a histologically or cytologically diagnosis of prostate cancer.
•All patients must have been diagnosed oligometastatic prostate cancer which meet the following criteria. (1) ≤5 metastatic lesions are found by imaging examination (2)No visceral metastasis was found (3) The diameter of a single lesion ≤5cm or the surface area ≤250cm2.
•Patients previously treated with surgical castration or androgen deprivation therapy must maintain a testosterone level of \<50ng/dl or \<1.7nmol/L during treatment. Also the treatment duration should be less than 9 months. Patients were previously treated with at least 6 cycles of abiraterone.
•PSA\<2ng/ml before enrollment.
•There was no PSA progression or radiographic progression during previous treatment.
•Primary lesion must be eligible for radical prostatectomy based on random radiographic assessment. ( Preoperative clinical staging \<T4 or achievable complete resection agreed by experienced surgeons is deemed as eligible for radical prostatectomy)
•Eastern Cooperative Oncology Group (ECOG) physical condition score ≤ 1.
•Patients must have adequate hematologic function, within 28 days prior to registration as evidenced by: white blood cell (WBC) ≥ 4.0 × 109 /L, platelets≥ 100 × 109 / L, hemoglobin ≥ 9g / dL, and international normalized ratio (INR) \< 1.5.
•Patients must have adequate hepatic function, within 28 days prior to registration, as evidenced by: total bilirubin (TBIL)≤1.5 x upper limit of normal (ULN),and SGOT (AST) and SGPT (ALT) ≤ 2.5 x ULN.
+2 more criteria

Exclusion Criteria

•Patients with visceral metastasis or more than 5 metastatic lesions are excluded.
•Patients were diagnosed metastatic castration-naive prostate cancer for more than 9 months or showed biochemical or radiographic progression before enrollment.
•Patients with unresectable primary lesion before enrollment based on CT/MRI.
•Patients received local treatments such as pre-focal treatment, radiotherapy and palliative endoscopic resection.
•Patients must not have New York Heart Association Class III or IV congestive heart failure at the time of screening. Patients must not have any thromboembolic event, unstable angina pectoris, myocardial infarction within 6 months prior to registration.
•Patients must not have uncontrolled severe hypertension, persistent uncontrolled diabetes, oxygen-dependent lung disease, chronic liver disease, or HIV infection.
•Patients must not have had other malignancies other than prostate cancer in the past 5 years, but cured basal cell or squamous cell skin cancers can be enrolled.

Locations (1)

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China

Key Dates

Start Date

January 1, 2021

Primary Completion Date

December 1, 2024

Completion Date

December 2, 2024

Last Updated

December 5, 2024

Enrollment

130

ACTUAL participants

Conditions

ProstatectomyOligometastatic Prostate CancerAbiraterone

Interventions

robot assisted laparoscopic prostatectomy + enlarged pelvic lymph node dissection

PROCEDURE

1.Abiraterone Acetate Tablets

DRUG

Prednisone Acetate Tablets

DRUG

Luteinizing Hormone-Releasing Hormone Analog

DRUG

Robotic Opioid-free Prostatectomy Enhanced Strategy (ROPES)

NCT07427043

Opioid Consumption, PostoperativeMultimodal Analgesia+3 more

View study

RECRUITINGNA

Safety and Tolerability of a Novel Implantable Device for the Treatment of Erectile Dysfunction

NCT06968494

Erectile Dysfunction Following Radical Prostatectomy

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 5, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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The Efficacy and Safety of Prostatectomy for Castration-Naive Oligometastatic Prostate Cancer

Inclusion Criteria

Exclusion Criteria

Robotic Opioid-free Prostatectomy Enhanced Strategy (ROPES)

Safety and Tolerability of a Novel Implantable Device for the Treatment of Erectile Dysfunction

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