Prognostic Value of Early Postoperative Prostate-Specific Antigen for Oncological Outcomes After Radical Prostatectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Impact of PSA Persistence on Metastasis-Free Survival (MFS)
研究概览
简要总结
This prospective observational study aims to evaluate the prognostic significance of early postoperative prostate-specific antigen (PSA) levels in patients undergoing radical prostatectomy for prostate cancer.
No investigational interventions will be performed. All diagnostic procedures, follow-up assessments, and treatments will be conducted in accordance with standard clinical practice and established prostate cancer management guidelines. Participation in the study will not influence treatment decisions.
详细描述
This is a prospective, single-center, observational, investigator-initiated study designed to evaluate the prognostic significance of early postoperative prostate-specific antigen (PSA) levels in predicting long-term oncological outcomes after radical prostatectomy (RP) for prostate cancer.
The study does not involve investigational medicinal products. No experimental interventions will be applied. Patient management will follow standard clinical practice and established national and international prostate cancer treatment guidelines. Participation in the study will not influence treatment decisions.
Approximately 100 radical prostatectomies are performed annually at the study center. It is anticipated that 400-500 participants will be enrolled over a 5-year recruitment period. No formal sample size calculation was performed due to the observational nature of the study.
All patients who fulfill the eligibility criteria will be offered to participate in the study during their inpatient stay for the operation.
First PSA measurement will be done at 4-8 weeks after surgery, preferably at 1 month.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patient is an adult biological male.
- •Patient has morphologically confirmed and untreated prostate cancer.
- •Patient who will be treated with open, laparoscopic or robot-assisted laparoscopic radical prostatectomy.
- •Patient is informed about this observational study and has signed the informed consent form.
排除标准
- •Patient has radiologically of morphologically confirmed prostate cancer metastases before the operation.
- •Patient received neoadjuvant prostate cancer treatment.
- •Patient is set to receive adjuvant treatment.
- •Patient has any contraindications for the operation.
研究组 & 干预措施
Persistent PSA group
Patients after radical prostatectomy with first postoperative prostate-specific antigen value of ≥0.1 ng/ml 4-8 weeks after radical prostatectomy.
干预措施: Radical Prostatectomy (Procedure)
Non-persistent PSA group
Patients after radical prostatectomy with first postoperative prostate-specific antigen value of <0.1 ng/ml 4-8 weeks after radical prostatectomy.
干预措施: Radical Prostatectomy (Procedure)
结局指标
主要结局
Impact of PSA Persistence on Metastasis-Free Survival (MFS)
时间窗: Up to 10 years after radical prostatectomy.
Comparison of metastasis-free survival between patients with and without PSA persistence.
Impact of PSA Persistence on Cancer-Specific Survival (CSS)
时间窗: Up to 10 years after radical prostatectomy.
Comparison of cancer-specific survival between patients with and without PSA persistence.
Impact of PSA Persistence on Overall Survival (OS)
时间窗: Up to 10 years after radical prostatectomy.
Comparison of overall survival between patients with and without PSA persistence.
Development of a Prognostic Nomogram Incorporating PSA Persistence
时间窗: Based on outcomes observed during up to 10 years of follow-up.
Development of a multivariable prognostic model incorporating early postoperative PSA status together with preoperative and postoperative clinicopathological variables to predict long-term oncological outcomes.
次要结局
- Impact of PSA Persistence on Biochemical Recurrence-Free Survival (BCRFS)(Up to 10 years after radical prostatectomy.)
- Incidence of PSA Persistence(Up to 10 years after radical prostatectomy.)
- Diagnostic Performance of PSMA PET-CT in Patients With Persistent PSA(Up to 1 year after radical prostatectomy.)
研究者
Gustas Sasnauskas
MD, PhD Candidate
Lithuanian University of Health Sciences