EUCTR2016-004694-41-GB进行中（未招募）1 期
A Multi-Centre, Open Label, Phase IIb Study, Evaluating the Safety, Tolerability and Efficacy of Targeted Intraprostatic Administration of PRX302 to Treat Men with Histologically Proven, Clinically Significant, Localised, Low- to Intermediate-Risk Prostate Cancer that is Associated with an MRI Lesion - Intraprostatic PRX302 injection to treat localised prostate cancer
Sophiris Bio Corp. 1258 Prospect Street La Jolla, CA 92037 USA0 个研究点目标入组 40 人开始时间: 2016年12月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •1.Men aged =40 years and life expectancy of =10 years.
- •2.Serum prostate-specific antigen (PSA) =15ng/mL.
- •3.In the planned treatment zone, histologically proven clinically significant prostate cancer of maximum Gleason Score 7 (3+4 or 4+3)
- •In the presence of Gleason sum of 7, the MCCL must not exceed 10mm.
- •In the presence of Gleason sum of 7, there is no minimum cancer core length requirement.
- •In the presence of Gleason patterns 3+3, the MCCL must exceed 5mm.
- •In the presence of Gleason sum of 6, the MCCL must not exceed 10mm.
- •4.Radiological stage T1-T2 N0 Mx/M0 disease.
- •5.A visible lesion on mpMRI, Prostate Imaging-Reporting and Data System (PI-RADS) (version 2) score 3, 4 or 5 and up to a maximum volume of 1mL that is accessible to administration of PRX302 via transperineal injection. mpMRI to be obtained at the screening visit or within 6 months prior to dosing (using the same MRI magnet strength that will be used for the patient’s in-study mpMRIs).
- •6.Targeted prostate biopsy within 6 months prior to dosing, with a clinically significant lesion correlating with an mpMRI visible lesion.
- •7.Written informed consent by the patient for participation in the study.
- •8.Patient has an understanding of the English language sufficient to understand written and verbal information about the study and consent process.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1.Prostate volume (PV) <20mL (20g).
- •2.Previous radiation therapy to the pelvis.
- •3.Androgen suppression or anti-androgen therapy within the 12 months prior to dosing, for prostate cancer.
- •4.Use of a 5-alpha reductase inhibitor within the 3 months prior to dosing.
- •5.Evidence of metastatic disease or nodal disease outside the prostate on bone scan or cross-sectional imaging.
- •6.Presence of any other clinically significant lesion (as defined above in inclusion criteria 3), other than the pre-identified lesion for treatment, outside of the planned treatment zone.
- •7.Inability to tolerate a transrectal ultrasound (TRUS).
- •8.Known allergy to latex or gadolinium (Gd).
- •9.Prior rectal surgery preventing insertion of the TRUS probe.
- •10.Any previous ablative procedures performed on the prostate, e.g., electroporation, radiofrequency ablation, high-intensity focused ultrasound (HIFU), cryosurgery, photochemical, thermal or microwave therapy to treat cancer of the prostate.
- •11.Any previous injected chemical or injected biological treatment performed on the prostate.
- •12.Transurethral resection of the prostate (TURP) for symptomatic lower urinary tract symptoms (LUTS) within the 6 months prior to dosing.
- •13.Unable to have pelvic MRI scanning (severe claustrophobia, permanent cardiac pacemaker, metallic implant, etc., likely to contribute significant artefact to images).
- •14.Presence of metal implants/stents in the urethra or any other non-MRI compatible metal objects.
- •15.Renal impairment with an estimated glomerular filtration rate (GFR) of <35mL/min (unable to tolerate Gd dynamic contrast-enhanced MRI).
- •16.Use of ANY of the following medications:
- •Anticoagulants (e.g., Coumadin, heparin) or platelet inhibitors (e.g., aspirin, nonsteroidal anti-inflammatory drugs [NSAIDs], clopidogrel [e.g., Plavix®]) within 5 days prior to dosing or anticipated for use any time within the first 3 days after dosing or per local guidelines.
- •Androgen deprivation therapy will not be permitted during study duration unless the development of metastases (rare) occurred during study follow-up. 5-alpha reductase inhibitors will not be permitted during the study until the post-treatment biopsies have been taken.
- •17.Any condition that may confound the assessment of safety and tolerability, such as current symptomatic prostatitis; acute or chronic or symptomatic genitourinary infection; or urinary retention requiring catheterisation within 12 months prior to dosing or elevated International Normalized Ratio (INR) >1.5 at the time of dosing.
- •18.Any acute or chronic medical condition that, in the opinion of the Investigator, increases the risk to the patient or the likelihood that the patient will be unable to complete the study.
- •19.Unable or unwilling to comply with the requirements of the protocol.
- •20.Participation in any investigational study within 30 days prior to dosing.
研究者
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