Prostate Cancer
Conditions
Keywords
prostate cancer, brachytherapy, spacer, side effect
Brief summary
The purpose of this study is to evaluate the usefulness of diluted DuraSeal product as a spacer between prostate and rectum in prostate cancer low dose brachytherapy.
Detailed description
Radiation therapy for prostate cancer leads to inappropriate radiation dose to the rectum wall leading rectum adverse effects in long term for some patients. A resorbable spaces between prostate and rectum could decrease the incidence of these side effect. In this trial, men with prostate cancer with intention to curative treatment by low dose brachytherapy will be recruited. Diluted DuraSeal will be applied between rectum and prostate at the end of the brachytherapy seed implantation procedure. After the implantation of the brachytherapy seeds, a needle is placed between rectum and prostate through perineal skin under transrectal ultrasound guidance. The proper position of the needle is confirmed by the injection of 10-15 ml sterile saline solution. After that, DuraSeal components are diluted in 1:1 with sterile saline and 6-10 ml of this diluted product will be injected using DuraSeal applicator. The resolution of the spacer will be followed by repeated plain computer tomography (CT) of pelvis performed a day before operation, a day after the operation, 4 weeks after the operation and 8 weeks after the operation. In addition, magnetic resonance imaging of pelvis performed 8 to 16 weeks after the operation. The space created between prostate and rectum will be documented by plain CT and magnetic resonance imaging. Rectum radiation dose will be calculated based on these scans. Time to DuraSeal resolution will be evaluated from the scans. Possible side effects will be collected by subject interviews during follow-up visits at 4, 8 and 12 weeks after the operation.
Interventions
DEVICEDuraSeal
Single dose of DuraSeal product with DuraSeal components diluted 1:1 in sterile saline injected between rectum and prostate
Sponsors
Oulu University Hospital
University of Oulu
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
50 Years to 76 Years
Healthy volunteers
No
Inclusion criteria
* prostate cancer patients with planned low dose brachytherapy for the treatment of prostate cancer
Exclusion criteria
* not willing to participate this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Spacer Volume Half Life | 1 day, 4 weeks, 8 weeks, up-to 16 weeks | Time to spacer resolution will be measured based on the distance between rectum wall and prostate on CT scans before operation and on defined time frame. In addition, magnetic resonance imaging of pelvis will be performed 8 to 16 weeks after the operation in order to confirm the extent of spacer. Spacer volume half life is reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Side Effects | 1 day, 4 weeks, 8 weeks, 12 weeks | Possible side effects will be collected by subject interview and physical examination on specified time frame. |
| Rectum Radiation Dose | 1 day, 4 weeks, 8 weeks | Rectum dose will be calculated based on CT scans after brachytherapy. |
Countries
Finland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Spacer Subjects with spacer injection
DuraSeal: Single dose of DuraSeal product with DuraSeal components diluted 1:1 in sterile saline injected between rectum and prostate | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Spacer |
|---|---|
| Age, Continuous | 66 year |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 10 Participants |
| Region of Enrollment Finland | 10 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
Spacer Volume Half Life
Time to spacer resolution will be measured based on the distance between rectum wall and prostate on CT scans before operation and on defined time frame. In addition, magnetic resonance imaging of pelvis will be performed 8 to 16 weeks after the operation in order to confirm the extent of spacer. Spacer volume half life is reported.
Time frame: 1 day, 4 weeks, 8 weeks, up-to 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spacer | Spacer Volume Half Life | 47 days | Standard Deviation 12 |
Secondary
Rectum Radiation Dose
Rectum dose will be calculated based on CT scans after brachytherapy.
Time frame: 1 day, 4 weeks, 8 weeks
Secondary
Side Effects
Possible side effects will be collected by subject interview and physical examination on specified time frame.
Time frame: 1 day, 4 weeks, 8 weeks, 12 weeks