Radical Prostatectomy Versus Radical Radiotherapy for Locally Advanced Prostate Cancer

Tongji Hospital

Status: Not yet enrolling

Conditions: Prostatic Neoplasms

Treatments: Other: Radical Radiotherapy; Procedure: Radical Prostatectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT04093375

2019CR101

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 18≤Age ≤75, at the time of randomization.
2. Confirmed as non-metastatic prostate adenocarcinoma by transrectal ultrasound biopsy in six months before enrollment and untreated.
3. Tumor stage (T, M, N): according to 2018 NCCN prostate cancer guidelines T3 stage Significant extra-capsular tumor extension M0 (no sign of distant metastases) Nx (regional lymph nodes cannot be assessed). For patients with T4, the tumor should be confined to the bladder neck, and bilateral ureters should not be invaded.
4. WHO score 0-1, ECOG score 0-2, and ASA grade I-III.
5. At least 5 years life expectancy.
6. The general condition and mental status of patients shall permit observation in accordance with the study protocol.
7. Signed Informed consent.

Exclusion criteria

1. Concomitant with other malignancies.
2. With severe systemic disease (cardio-cerebrovascular disease, etc.) cannot tolerate surgery or radiotherapy.
3. Clinical significant abnormal laboratory values at the discretion of the investigator, e.g. severe kidney function GFR < 30 ml/ml or elevated liver transaminases above > 10 ULN.
4. Involved in other clinical trials simultaneously.
5. Any medical condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 2 patient groups

Radical Prostatectomy

Experimental group

Description:

Patients with locally advanced prostate adenocarcinoma receives Radical Prostatectomy with or without enlarged lymph node dissection

Treatment:

Procedure: Radical Prostatectomy

Radical Radiotherapy

Active Comparator group

Description:

Patients with locally advanced prostate adenocarcinoma receives Radical Radiotherapy with adjuvant androgen deprivation therapy

Treatment:

Other: Radical Radiotherapy