CLINICAL PROTOCOL for the INVESTIGATION Of the ProSpace* Balloon Spacer Pivotal Study BP-007
- Conditions
- prostate cancerprostate carcinoma10036958
- Registration Number
- NL-OMON54912
- Lead Sponsor
- BioProtect Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
- 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
and
- 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
compliant;
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>There are two co-primary endpoints, one for safety and one for effectiveness.<br /><br>The primary safety endpoint is based on the occurrence of Grade 1 or greater<br /><br>rectal adverse events and implantation procedure related adverse events with a<br /><br>duration of at least 2 days through the first six months.<br /><br>The primary effectiveness endpoint is assessed only for subjects who receive<br /><br>the ProSpace device. The primary effectiveness endpoint is a binary assessment<br /><br>of whether a subject obtains at least a 25% reduction in the volume of the<br /><br>rectum receiving greater than or equal to 70 Gy (VRectum 70). If we denote ve<br /><br>to be the percentage of subjects meeting the VRectum 70 success criteria in the<br /><br>ProSpace Balloon arm. </p><br>
- Secondary Outcome Measures
Name Time Method <p>• The rate of Grade 2 or greater rectal or implantation procedure related<br /><br>adverse events with a duration of at least 5 days and implantation procedure<br /><br>related adverse events in the ProSpace Group subjects compared to Control Group<br /><br>subjects in the 6 month follow-up period post marking and/or balloon<br /><br>implantation.<br /><br>• Degree of all GU acute toxicity as determined by the Expanded Prostate Cancer<br /><br>Index Composite (EPIC).<br /><br>• Additional dosimetry parameters (DRectum100, DRectum90, DRectum80, DRectum70)<br /><br>will be evaluated in the balloon arm only, where subjects will serve as their<br /><br>own control (dosimetry reduction after balloon implantation) as the dosimetry<br /><br>parameters are compared to their baseline values per subject.<br /><br>• Core lab evaluation of distance of rectal wall from the prostate at baseline<br /><br>and last XRT visit. This data will be measured and quantified.</p><br>