Clinical trial · Observational

Comparison of Nerve-sparing Techniques in Radical Prostatectomy for Oncological Outcome and Functional Recovery.

A Prospective, Multi-center, Real-world Study on the Comparison of Different Nerve-sparing Techniques in Retzius-sparing Robot-assisted Radical Prostatectomy for Oncological Outcome and Functional Recovery.

NCT06524219CI-TRIAL-00079895not yet recruitingClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

To evaluate the difference among three nerve-sparing techniques(unilateral intrafascial resection, bilateral intrafascial resection, bilateral extrafascial resection) of oncological outcome and functional recovery.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Prostate Cancer	Malignant Prostate Neoplasm	CURATED_EXACT	0.92

Interventions

Interventions (3)

Intervention	Type	Mapped drug	Match
bilateral extrafascial resection	Procedure	—	UNRESOLVED
bilateral intrafascial resection	Procedure	—	UNRESOLVED
unilateral intrafascial resection	Procedure	—	UNRESOLVED

Design

Arms and outcomes

Arms (3)

label
unilateral intrafascial resection
description
Subjects whose preoperative MRIs indicate the lesions are located in the peripheral zone of one side near the capsule, unable to be performed intrafascial resection, and no major lesion or only slight lesion in the peripheral zone of the other side, are going to be conducted unilateral intrafascial resection in Retzius-sparing robot-assisted radical prostatectomy.
interventionNames
1. Procedure: unilateral intrafascial resection
label
bilateral intrafascial resection
description
Subjects who have low or median-risk tumors and no extracapsular extension for major lesion, are going to be conducted bilateral intrafascial resection in Retzius-sparing robot-assisted radical prostatectomy.
interventionNames
1. Procedure: bilateral intrafascial resection
label
bilateral extrafascial resection
description
Subjects who have major lesion that is in the peripheral zone, MRIs that show that the lesion may invade or locate at the edge of the transitional zone, and Gleason score of 4+4 or greater, are going to be conducted bilateral intrafascial resection in Retzius-sparing robot-assisted radical prostatectomy.

Eligibility

Eligibility (as posted)

Sex: Male
Minimum age: 18 Years
Maximum age: 80 Years

Show eligibility criteria text

Inclusion Criteria:

* Men aged ≥18 years and ≤80 years;
* Histologically proven prostate adenocarcinoma with clinical stage \< T3(no capsule break)
* Clinically localized prostate cancer in very low, low, or intermediate risk groups according to National Comprehensive Cancer Network(NCCN) guidelines (2019 v4) ;
* Eastern Cooperative Oncology Group(ECOG) score of 0 or 1;
* Life expectancy greater than 10 years;
* Patients who are willing to accept robot-assisted radical prostatectomy after informed existing treatment plan, must sign the informed consent form.

Exclusion Criteria:

* Surgeon thinks that the patient has an unresectable disease;
* patients who have already applied androgen deprivation therapy(ADT);
* Preoperative images suggest that the local lymph nodes were larger than 2 cm or suggest bone or distant metastasis;
* Any contraindication;
* Previous treatment of prostate cancer, including but not limited to surgery, hormone therapy, chemotherapy, radiotherapy, targeted therapy and immunotherapy;
* Patients with a history of transurethral resection or enucleation of the prostate;
* Severe systemic disease that may interfere with the data, assessment, or compliance;
* Patients who are participating in other clinical trials;
* Refusing to sign the informed consent
* Patients that are considered to be not suitable to be included by the researchers.

References

Publications (0)

Data not yet available

No reference posted for this study.