Outcomes of Local Treatment for Oligometastatic Prostate Cancer Diagnosed Using PSMA PET Imaging: OLIGOMET Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 500
- 主要终点
- Radiographic progression-free survival (rPFS)
研究概览
简要总结
PSMA-PET/CT or PSMA-PET/MRI are more accurate imaging modalities compared to CT/BS; in approximately 10-20% of high-risk patients diagnosed using conventional imaging PSMA-PET up-stages the disease. Therefore a substantial proportion of high-risk patients previously considered as non-metastatic are expected to be diagnosed with oligometastatic disease. While standard treatment pathways exist for patients with non-metastatic or oligometastatic disease confirmed using conventional imaging, less is known about the optimal management of patients with oligometastatic prostate cancer on PSMA-PET.
Currently, data on the safety, effectiveness and oncologic outcomes of local therapies in oligometastatic patients diagnosed using PSMA-PET have been poorly reported so far. Thus, there is a need for a prospectively maintained database to collect real-world clinical data to produce high-quality research on the optimal management in oligometastatic prostate cancer who underwent PSMA-PET for primary staging and subsequent local therapy. This database will allow centers to retro- and prospectively collect data to facilitate analysis and assessment of the outcomes of oligometastatic patients managed with local therapy.
详细描述
The Emerging Role of PSMA-PET in Prostate Cancer Imaging
PSMA-PET, in conjunction with CT or MRI, has significantly enhanced the precision of prostate cancer staging. Traditional imaging modalities, such as CT or BS, often fail to accurately determine the disease's extent. In contrast, PSMA-PET offers a more precise diagnostic alternative, especially in identifying oligometastatic cases among high-risk prostate cancer patients. Remarkably, 10-20% of patients with unfavorable prostate cancer initially classified as non-metastatic through conventional imaging are reclassified as oligometastatic when reassessed with PSMA-PET. This reclassification is pivotal, possibly influencing treatment decisions and prognostic outcomes.
The Need for a Focused Study
Oligometastatic prostate cancer represents an intermediate stage between localized and systemic disease, reflecting an early phase in metastatic progression. These tumors not only exhibit unique biological characteristics but also constitute a distinct clinical entity, offering possibilities for long-term control or even cure. Numerous studies demonstrated benefits from combining local and metastasis-directed therapies with systemic treatment in oligometastatic prostate cancer patients diagnosed with conventional imaging. However, despite diagnostic advancements and the evolving uptake of PSMA-PET, substantial gaps persist in the understanding of optimal management for oligometastatic prostate cancer identified with next-generation imaging.
Due to the diagnostics advancements and dynamically changing treatment landscape with various local, systemic, and metastasis-directed therapies, this topic requires a prospective multicenter registry. To address this, the investigators have initiated this prospective cohort study focusing on the efficacy and safety of local therapies in oligometastatic prostate cancer patients diagnosed with PSMA-PET, performed under the umbrella of EAU Young Academic Urologists (YAU) Prostate Cancer Working Group.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Oligometastatic prostate cancer diagnosed using PSMA PET defined as cM1a and/or cM1b with ≤5 osseous metastases and/or M1c with ≤3 lung lesions, with or without cN positivity.
- •Oligometastatic prostate cancer treated with primary local therapy such as radical prostatectomy or radiation therapy.
- •Any Gleason Score, any cT stage, any PSA
排除标准
- •Visceral metastases (apart from lungs).
- •Neoadjuvant therapy prior to first PSMA PET.
- •Non-metastatic prostate cancer.
- •Patients who did not undergo imaging before local treatment.
结局指标
主要结局
Radiographic progression-free survival (rPFS)
时间窗: From date of diagnosis until the date of first documented radiographic progression or date of death from any cause, whichever came first, assessed up to 100 months
Defined as increase in size of existing lesion or appearance of new lesion (on any subsequent follow-up imaging modality used for baseline assessment), or death.
Clinical progression-free survival (cPFS)
时间窗: From date of diagnosis until the date of first documented clinical progression or date of death from any cause, whichever came first, assessed up to 100 months
Defined as new prostate cancer-related symptom, radiographic progression, initiation of new treatment, or death.
Castration resistance-free survival (CRPC-FS)
时间窗: From date of diagnosis until the date of castration resistance or date of death from any cause, whichever came first, assessed up to 100 months
Castration resistance is defined as: castrate serum testosterone \<50ng/dL or 1.7nmol/L, plus either biochemical progression (three consecutive rises in PSA at least one week apart resulting in two 50% increases over the nadir, and a PSA \> 2ng/mL) or radiographic progression (\> 2 new bone lesions or a new soft tissue lesion).
次要结局
- Functional outcomes - potency(6 months, 1, 2, and 3 years after local therapy.)
- Cancer-specific survival(From date of diagnosis until the date of death from prostate cancer, assessed up to 100 months)
- Local therapy complications(From the time of local therapy to 30 days after treatment.)
- Overall survival(From date of diagnosis until the date of death from any cause, assessed up to 100 months)
- Functional outcomes - continence(6 months, 1, 2, and 3 years after local therapy.)
- Pathological response to systemic therapy(Measured immediately after the surgery)
- Imaging response to systemic therapy(Measured from the administration of systemic treatment until the end of treatment, assessed up to 100 months)
研究者
Dr. Pawel G. Rajwa
Principal Investigator
Medical University of Vienna