Effect of neoadjuvant Degarelix on MRI-guided transurethral ultrasound ablation in patients with intermediate-risk prostate cancer: A pilot study
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- To measure prostate and tumor volume change after neoadjuvant ADT using T2-weighted MRI.
研究概览
简要总结
The first part of the study, the pre-TULSA ADT period, aims to investigate the impact of short-term ADT using degarelix on prostate and tumor characteristics on MRI, and the second part, the post-TULSA period, the synergistic impact of combining neoadjuvant degarelix with whole-gland TULSA on treatment and clinical outcomes.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male age ≥ 40 years, candidate for radical Pca treatment
- •Informed consent: The patient must speak Finnish, English, or Swedish and must be able to understand the meaning of the study. The patient must be willing and able to sign the appropriate Ethics Committee (EC) approved informed consent documents in the presence of the designated staff.
- •Estimated life expectancy > 8 years
- •At least one MRI-visible and biopsy-concordant tumor defined as Prostate Imaging–Reporting and Data System v2 (PI-RADS v2.1) ≥3
- •Biopsy-confirmed, intermediate-risk localized Pca: Clinical or radiological stage ≤ T2c, N0, M0, ISUP GG 2 or 3, Biopsy obtained ≥ 6 weeks and ≤ 12 months before treatment
- •PSA ≤ 20 ng/ml
- •No prior definitive treatment of Pca
- •Eligible for MRI
- •Eligible for general anesthesia (American Society of Anesthesiologists Class III or less
- •Patients taking 5-alpha reductase inhibitors (5-ARIs) are eligible if use is discontinued 12 months before and throughout the study period
排除标准
- •Prior Pca treatment with chemotherapy or hormonal therapy, including chemical or surgical castration, antiandrogen therapy, or androgen synthesis inhibitors
- •Known allergy or contraindication to gadolinium or gastro-intestinal anti-spasmodic drug (e.g., glucagon, buscopan)
- •Any other conditions that might compromise patient safety, based on the clinical judgment of the responsible urologist
- •Secondary malignancy unless disease-free survival is > 8 years
- •Relative or absolute contraindication to degarelix
- •Severe, active cardiovascular comorbidity including unstable angina pectoris, congestive heart failure, deep vein thrombosis, pulmonary embolism, or myocardial infarction within the last six months
- •Inability to undergo MRI due to claustrophobia or contraindications (cardiac pacemaker, intracranial clips, etc.
- •Prostate calcifications obstructing the planned ultrasound beam path in the line of sight of the MRI visible tumo
- •Prostate cysts at the prostate capsule within the planned ultrasound beam path in the line of sight of the MRI visible tumo
- •Evidence of extraprostatic disease based on imaging (MRI, bone scintigraphy, single-photon emission tomography, computed tomography, prostate-specific membrane antigen-positron emission tomography [PSMA-PET]) or histopatholog
- •History of chronic inflammatory conditions (e.g., inflammatory bowel disease) affecting the rectum (also includes rectal fistula and anal/rectal stenosis)
- •Hip replacement surgery or other metal in the pelvic area
结局指标
主要结局
To measure prostate and tumor volume change after neoadjuvant ADT using T2-weighted MRI.
To measure prostate and tumor volume change after neoadjuvant ADT using T2-weighted MRI.
To measure tumor-capsule contact length change after neoadjuvant ADT using T2-weighted MRI.
To measure tumor-capsule contact length change after neoadjuvant ADT using T2-weighted MRI.
To measure the change in vascular perfusion to the prostate and tumor after neoadjuvant ADT using dynamic contrast-enhanced T1-weighted MRI.
To measure the change in vascular perfusion to the prostate and tumor after neoadjuvant ADT using dynamic contrast-enhanced T1-weighted MRI.
To evaluate tissue structural changes after neoadjuvant ADT using quantitative analysis of the prostate’s intensity, shape, and texture on T2-weighted, quantitative T2 relaxation time mapping, and diffusion-weighted MRI.
To evaluate tissue structural changes after neoadjuvant ADT using quantitative analysis of the prostate’s intensity, shape, and texture on T2-weighted, quantitative T2 relaxation time mapping, and diffusion-weighted MRI.
To measure thermal coverage of the target volume achieved by whole-gland TULSA by comparing physician-defined target boundaries to MRI measurements of temperature distributions, thermal dose distributions, and acute treatment-induced perfusion defect.
To measure thermal coverage of the target volume achieved by whole-gland TULSA by comparing physician-defined target boundaries to MRI measurements of temperature distributions, thermal dose distributions, and acute treatment-induced perfusion defect.
To evaluate the subsequent safety, oncological, and quality-of-life outcomes of these patients for a period of 5 years.
To evaluate the subsequent safety, oncological, and quality-of-life outcomes of these patients for a period of 5 years.
次要结局
未报告次要终点
研究者
Mikael Anttinen
Scientific
Turku University Central Hospital