NCT04093375Not yet recruiting
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
Source: ClinicalTrials.gov · Last updated 24 Oct 2019 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 600 (estimated)
- First submitted
- 16 Sept 2019
- Start date
- 1 Nov 2019
- Primary completion date
- 31 Dec 2021
- Lead sponsor
- Tongji Hospital
- Diseases
- Prostate cancer
- NCT number
- NCT04093375
What you commit to
- Study type: Interventional
- Planned participants: 600
- From 1 Nov 2019 to the primary completion date, 31 Dec 2021
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant with other malignancies.
Other illness
- With severe systemic disease (cardio-cerebrovascular disease, etc.) cannot tolerate surgery or radiotherapy.
- Any medical condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
Lab values
- 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.
Other
- Involved in other clinical trials simultaneously.
Who the study is looking for
- 18≤Age ≤75, at the time of randomization.
- Confirmed as non-metastatic prostate adenocarcinoma by transrectal ultrasound biopsy in six months before enrollment and untreated.
- 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.
- WHO score 0-1, ECOG score 0-2, and ASA grade I-III.
- At least 5 years life expectancy.
- The general condition and mental status of patients shall permit observation in accordance with the study protocol.
- Signed Informed consent.
Age in the registry: 18 years to 80 years · Sex: Male · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.