NCT04093375

Radical Prostatectomy Versus Radical Radiotherapy for Locally Advanced Prostate Cancer

Primary Radical Prostatectomy Versus Primary Radiotherapy for Locally Advanced Prostate Cancer: an Open Randomized Clinical Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Tongji Hospital · Academic / Other
• Sex: Male
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This prospective, open randomized clinical trial seeks to investigate whether radical prostatectomy with androgen deprivation therapy improves prostate-cancer specific survival and quality of life in comparison with radical radiation treatment with androgen deprivation therapy among patients diagnosed locally advanced prostate cancer. Lack of extensive PSA screening in mainland China, many new cases of prostate cancer are LAPCa. Surgery and/or radiation plus attempted chemotherapy are curative treatment for advanced solid malign tumors to control and eliminate the local and micro metastases. LAPCa is easy to metastasis, relapse and has a poor prognosis. For LAPCa, a single RP approach is generally not the preferred option because it is generally considered that radical surgery is difficult to completely remove the lesion and the long-term prognosis is not ideal. However, androgen deprivation therapy promotes the prognosis of LAPCa with lymph nodes or seminal vesicle metastases and improves the local control rate of tumor. What is more, for early localized prostate cancer, RT has similar efficacy to RP, for advanced tumor RT can not only relieve urinary tract obstruction and other symptoms, but also improve biochemical progression free survival and local oncological control. A randomized clinical trial comparing two multimodal treatment including RP or RT with ADT regimens is therefore warranted.

Conditions

• Prostatic Neoplasms

Interventions

Type	Name	Description
PROCEDURE	Radical Prostatectomy	Radical prostatectomy with or without androgen deprivation therapy
OTHER	Radical Radiotherapy	Radical Radiotherapy with adjuvant androgen deprivation therapy

Timeline

• Start date: 2019-11-01
• Primary completion: 2021-12-31
• Completion: 2026-12-31
• First posted: 2019-09-18
• Last updated: 2019-10-24