NCT05790213招募中2 期
Phase II Trial of Focal Prostate Ablation Combined With Androgen Deprivation Therapy for Prostate Cancer Treatment
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Number of participants with clinically significant residual prostate cancer in ablated prostate tissue following study treatment
研究概览
简要总结
The purpose of this research is to gather information on the safety and effectiveness of combining focal prostate ablation therapy ((aka Focal Therapy, a surgical procedure) and androgen deprivation therapy (hormone therapy).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Subjects must have intermediate-risk PCa as defined by the below criteria:
- •a. Favorable intermediate-risk PCa: i. ≤ clinical stage T2c, GG2, and PSA ≤ 10 ng/mL, and <50% positive biopsy cores with PCa b. Unfavorable intermediate-risk PCa: i. ≤ clinical stageT2c, GG2, and PSA 10-20 ng/mL, or ≥50% positive biopsy cores with PCa, or ii. ≤ clinical stage T2c, GG3, and PSA < 20 ng/mL
- •No mpMRI evidence of extra-prostatic extension (EPE) or seminal vesicle invasion, and if seminal vesical invasion is suspected, it must be excluded by prostate biopsy.
- •Subjects must have chosen to get Focal Therapy for the treatment of prostate cancer.
- •Subjects must have confirmed non-metastatic PCa following SOC screening for patients with unfavorable intermediate-risk PCa, a combination of computed tomography imaging of the abdomen and pelvis (CTAP) and technetium-99-mDP nuclear medicine bone scan (BS) and/or prostate-specific membrane antigen positron emission tomography (PSMA/PET) scan prior to enrollment. The imaging studies should be obtained within 6-months of enrollment. Additional imaging is not required for men with favorable intermediate-risk PCa.
- •Subject must be male ≥ 18 years-old.
- •Subjects must have a life expectancy of at least 10-years per the opinion of the treating investigator.
- •Subjects must be designated as Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 or Karnofsky Performance Status Scale Score ≥ 60%, see Appendix A).
- •Subjects must be fit to undergo general anesthesia and the FT surgical procedure, which includes adequate visualization of the prostate gland on transrectal ultrasound imaging, access to the urethra, perineum and rectum, as well as be tolerant of lithotomy positioning in the opinion of the treating investigator or the operating surgeon(s) if not the same as the treating investigator.
- •Subjects must have adequate organ and marrow function as defined below:
- •Hemoglobin ≥ 10 g/dL Leukocytes ≥ 3,000/mcL Absolute neutrophil count ≥ 1,500/mcL Platelets ≥ 100,000/mcL Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) AST(SGOT)/ALT(SGPT) ≤ 2.5 × institutional ULN Creatinine < 1.5 institutional ULN OR Calculated or measured creatinine clearance > 50 mL/min/1.73 m2 eGFR >30 mL/min using the MDRD (modification of diet and renal disease) formula Serum albumin ≥3.0 g/dL Serum potassium ≥3.5 mmol/L
- •Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
- •Subjects who are sexually active with a woman of childbearing potential must agree to use a condom with spermicidal foam/gel/film/cream/suppository and his partner must also be practicing a highly effective method of contraception (i.e., established use of oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device or intrauterine system) during treatment and for 3-months following the last ADT treatment.
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Subject has had prior or current PCa therapies, such as biologic, chemotherapy, hormone therapy, radiotherapy or surgery for PCa. Subjects may not have had undergone pelvic radiation, chemotherapy or immunotherapy treatment for a separate hematologic or visceral malignancy within 6-months of enrollment in the present study.
- •Subjects with locally advanced, nodal or metastatic prostate cancer.
- •Subjects who are unfit for pelvic mpMRI scanning (e.g., severe claustrophobia, permanent cardiac pacemaker, metallic implants that are likely to contribute to significant image artifacts, allergy or contraindication to gadolinium contrast agent.
- •History of allergy or intolerance to study drug components.
- •History of bilateral orchiectomy.
- •If the subject has an uncontrolled or major debilitating inter-current illness.
- •Subjects who are receiving any other investigational agents, or who have received other investigational agents in the past and who are no longer receiving these investigational agents may be eligible at the discretion of the principal investigator (PI).
- •Judgment by the treating investigator or PI that the subject is unsuitable to participate in the study and the subject is unlikely to comply with study procedures, restrictions and requirements.
研究组 & 干预措施
Treatment Arm
Experimental
Participants will receive Androgen deprivation therapy (ADT) followed by Focal prostate ablation (focal therapy)
干预措施: Androgen Deprivation Therapy (ADT) (Drug)
Treatment Arm
Experimental
Participants will receive Androgen deprivation therapy (ADT) followed by Focal prostate ablation (focal therapy)
干预措施: Focal prostate ablation (focal therapy) (Procedure)
结局指标
主要结局
Number of participants with clinically significant residual prostate cancer in ablated prostate tissue following study treatment
时间窗: End of Treatment (approximately 4-5 months)
Proportion of participants that have residual cancer in ablated prostate tissue. Residual disease will be measured by MRI.
Number of participants with clinically significant residual prostate cancer in unablated prostate tissue following study treatment
时间窗: End of Treatment (approximately 4-5 months)
Proportion of participants that have residual cancer in unablated prostate tissue. Residual disease will be measured by MRI.
Number and grade of complications [Safety]
时间窗: 6-months following treatment
Number and grade of complications will be reported. Number and grade of complications will be reported. The number and severity by Common Terminology Criteria for Adverse Events (CTCAE) grade of reported complications will be reported.
次要结局
- Proportion of men converting therapy or dying of prostate cancer during study(12 months after FT)
- Post Treatment biopsy with no prostate cancer(6 months after FT)
- Measuring change in genitourinary and sexual function and health-related quality of life (measured by HRQoL)(6-and 12-months after FT)
- PSA response to the combination treatment(Baseline, 3-months, 6-months, and 1-year from FT)
- Proportion of men with normal baseline serum(6-, 9- and 12-months after FT.)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
2 期
PET/MR for Prostate Cancer Restaging: a Phase II Prospective Monocentric StudyProstate CancerNCT05806853IRCCS San Raffaele60
终止
2 期
Multi-Epitope TARP Peptide Autologous Dendritic Cell Vaccination in Men With Stage D0 Prostate CancerProstate CancerProstatic NeoplasmsNCT02362451National Cancer Institute (NCI)7
进行中（未招募）
2 期
A study to investigate whether a combined Positron emission tomography (PET) and computerised tomography (CT) scan which utilises a tracer called Prostate Specific Membrane Antigen (PSMA) - a substance expressed by prostate cancer cells - can be used to better identify locally recurrent prostate cancer in men with a rising Prostate Specific Antigen (PSA) following radical prostatectomy. The study will then measure the impact of early salvage radiation therapy using advanced localisation techniques on patient survival, clinical toxicity, health related quality of life and prostate cancer-specific quality of life.Recurrent prostate cancerCancer - ProstateACTRN12615001183572Icon Cancer Foundation110
招募中
不适用
To Evaluate an MRI-based Optimized Prostate Cancer Diagnostic Pathway Powered by Artificial IntelligenceProstate CancerNCT06360523Chinese University of Hong Kong368
已完成
2 期
Vaccine Therapy in Treating Patients With Recurrent Prostate CancerAdenocarcinoma of the ProstateRecurrent Prostate CancerNCT00109811National Cancer Institute (NCI)32