to demonstrate that the ProSpace, when properly inserted between the prostate and the rectum is safe and effective in reducing the volume of the rectum receiving greater or equal to 70 Gy (VRectum70) by means of IMRT in prostate cancer patients…
ID
Source
Brief title
Condition
- Prostatic disorders (excl infections and inflammations)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
There are two co-primary endpoints, one for safety and one for effectiveness.
The primary safety endpoint is based on the occurrence of Grade 1 or greater
rectal adverse events and implantation procedure related adverse events with a
duration of at least 2 days through the first six months.
The primary effectiveness endpoint is assessed only for subjects who receive
the ProSpace device. The primary effectiveness endpoint is a binary assessment
of whether a subject obtains at least a 25% reduction in the volume of the
rectum receiving greater than or equal to 70 Gy (VRectum 70). If we denote ve
to be the percentage of subjects meeting the VRectum 70 success criteria in the
ProSpace Balloon arm.
Secondary outcome
• The rate of Grade 2 or greater rectal or implantation procedure related
adverse events with a duration of at least 5 days and implantation procedure
related adverse events in the ProSpace Group subjects compared to Control Group
subjects in the 6 month follow-up period post marking and/or balloon
implantation.
• Degree of all GU acute toxicity as determined by the Expanded Prostate Cancer
Index Composite (EPIC).
• Additional dosimetry parameters (DRectum100, DRectum90, DRectum80, DRectum70)
will be evaluated in the balloon arm only, where subjects will serve as their
own control (dosimetry reduction after balloon implantation) as the dosimetry
parameters are compared to their baseline values per subject.
• Core lab evaluation of distance of rectal wall from the prostate at baseline
and last XRT visit. This data will be measured and quantified.
Background summary
The ProSpace* Balloon System consists of the balloon and it*s deployer. The
ProSpace Balloon (*ProSpace*) is intended to temporarily position the anterior
rectal wall away from the prostate during radiotherapy for prostate cancer and
in creating this space it is the intent of the ProSpace to reduce the radiation
dose delivered to the anterior rectum.
This randomized controlled trial will demonstrate that ProSpace, when used in
prostate cancer patients undergoing radiotherapy by means of IMRT, reduces the
radiation dose delivered to the anterior rectum.
Study objective
to demonstrate that the ProSpace, when properly inserted between the prostate
and the rectum is safe and effective in reducing the volume of the rectum
receiving greater or equal to 70 Gy (VRectum70) by means of IMRT in prostate
cancer patients undergoing radiotherapy
Study design
This study will be a prospective, multi-center, randomized, double-arm, single
blind, concurrently controlled study.
Intervention
One group receives IMRT + marking + ProSpace implantation and the other group
receives IMRT + marking. The ProSpace will be inserted during the same session
as the marking.
Study burden and risks
Risks associated with the use of the ProSpace Balloon System in conjunction
with the control procedure (marking and IMRT) are expected to be comparable to
the risks associated with the control procedure alone. BioProtect believes
that the potential benefit for the patients in the ProSpace Balloon group is
higher than the potential risk. Inserting the ProSpace Balloon in situ between
the prostate and the rectum will enable admission of higher dosage whether as
total (accumulative) or per session (hypofractionation) or both, potentially
reducing acute and late and chronic rectal toxicity.
The insertion of the ProSpace Balloon is usually harmless, however procedure
related complications cannot entirely be excluded. The assumed potential risk
of using the ProSpace Balloon is mainly the potential risk of rectal
perforation and from injury during the implantation procedure. It should be
noted however, that unlike the late complications associated with high-dose
radiation that are chronic and may take years for resolution, this potential
risk is temporary and reversible.
Tsur St. 8
Tzur Yigal 4486200
IL
Tsur St. 8
Tzur Yigal 4486200
IL
Listed location countries
Age
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT03400150 |
| CCMO | NL71222.068.19 |