CLINICAL PROTOCOL for the INVESTIGATION Of the ProSpace* Balloon Spacer Pivotal Study BP-007 - ProSpace* Balloon Spacer Pivotal Study BP-007

BioProtect Ltd.0 个研究点目标入组 40 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

暂无简介。

•- Be at least 18 years of age;
•- Have been histologically diagnosed with invasive adenocarcinoma of the
•prostate, at clinical stage T1-T3 that is locally confined or extracapsular
•with no posterior extension (i.e., not involving the rectum);
•o The stage of adenocarcinoma will be determined by biopsy. For patients who
•have very-low or low-risk prostate cancer (i.e., T1c or T2a, Gleason less than
•or equal to 3+3, and PSA less than 10 ng/mL), the biopsy may be taken up to 9
•months prior to screening. For all others, the biopsy must be done no greater
•than 6 months prior to screening.
•o The presence/absence of posterior extension will be determined by MRI. For
•patients who have very-low or low-risk prostate cancer (T1c or T2a, Gleason
•less than or equal to 3+3, and PSA less than 10 ng/mL), the MRI may be taken up
•to 9 months prior to screening. For all others, the MRI must be taken no
•greater than 6 months prior to screening.
•- Be scheduled for radiation therapy (XRT) for prostate cancer by means of IMRT
•- Be willing to adhere to the follow-up schedule and protocol requirements.

•- Pelvic lymph node radiotherapy is planned;
•- Any prior invasive malignancy (except non-melanomatous skin cancer) unless
•the subject has been disease free for a minimum of 5 years;
•- Prior radical prostatectomy;
•- Prior cryosurgery or radiotherapy for prostate cancer, or other local therapy
•for prostate cancer;
•- Prior radiotherapy to the pelvis, including brachytherapy;
•- American Urological Assn. (AUA) Symptom Score > 20;
•- Active inflammatory bowel disease;
•- Known or suspected rectal carcinoma;
•- History of prior surgery involving the rectum or anus;
•- Venereal warts in the region;
•- Prior surgical procedure involving the peri-rectal and/or peri-prostatic area;
•- Current urinary tract infection;;
•- Acute or chronic prostatitis;
•- Acute infection requiring intravenous antibiotics at the time of screening;
•- Uncontrolled bleeding disorders;
•- Unsuitability for anesthesia in the opinion of the anesthesiologist;
•- Currently taking anticoagulants or NSAIDS that cannot be stopped for
•sufficient time prior to the implantation procedure;
•- EU citizens may not be enrolled by sites located at any site that is not GDPR
•- Currently incarcerated or
•- Participation in any other investigational drug, biologic or medical device
•study within the 30 days prior to the study surgery.
•- Intra-operative exclusion criteria for the balloon arm subjects only:
•inability to perform proper dissection between prostate and rectum.

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