Phase 3
Completed N=222
SpaceOAR System Pivotal Study
Source: ClinicalTrials.gov NCT01538628 ↗Enrolled (actual)
222
Serious AEs
14.0%
Results posted
Mar 2021
Primary outcomePrimary: Number of Subjects Achieving a Reduction of 25% or Greater in Percent Volume of the Rectum Receiving at Least 70 Gy Measured From CT Scans Acquired Pre and Post SpaceOAR Hydrogel Injection — 143 Participants — p=.0001
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
Evaluate the safety of the SpaceOAR System when the hydrogel is injected between the rectum and prostate in men undergoing radiation therapy (IG-IMRT)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Achieving a Reduction of 25% or Greater in Percent Volume of the Rectum Receiving at Least 70 Gy Measured From CT Scans Acquired Pre and Post SpaceOAR Hydrogel Injection |
143 | .0001 sig |
| PRIMARY Percentage of Subjects Experiencing Grade 1 or Greater Rectal or Procedure Adverse Events Post Index Procedure |
34.2; 31.5 | — |
| SECONDARY Percentage of Subjects Experiencing Grade 2 or Greater Rectal or Procedure Adverse Events in the 6 Months Following the Index Procedure |
10; 3 | — |
| SECONDARY Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Score Following Index Procedure |
-11.69; -11.20; 1.38; -0.83; 0.12; 0.30 | — |
| SECONDARY Percentage of Subjects Requiring at Least One Medication Change for Mitigation of Rectal or Urinary Symptoms or for Procedure-related Events in the 6 Months Following the Index Procedure |
56.4; 63.9 | — |
| SECONDARY Number of SpaceOAR Subjects Experiencing a Procedure-Related Adverse Event (AE) Prior to Initiation of Radiation Therapy |
14 | — |
| SECONDARY Number of Subjects Experiencing a Delay in Radiation Therapy Associated With a Procedure or Device-Related Adverse Event |
0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects greater than 18 years old
- Subjects must have pathologically confirmed invasive adenocarcinoma of the prostate and must be planning to undergo IMRT
- Subjects must have clinical stage T1 or T2 as determined from a biopsy taken within 6 months of the baseline/screening visit with Gleason Score less than or equal to 7
- Subjects Screening/Baseline laboratory testing must meet the following laboratory value criteria: PSA less than or equal to 20 ng/mL,hematocrit greater than 30%,serum creatinine less than 2.0 mg/dl, serum AST and ALT less than 2.5 times upper limit of institution normal, and serum bilirubin less than 2.0 mg/dl
- Subject or authorized representative, has been informed of the nature of the study and has provided written informed consent, approved by the appropriate Institutional Review Board (IRB) of the respective clinical site
Exclusion Criteria
- Prostate greater than 80cc documented within 3 months preceding the Screening/Baseline visit
- Subjects with extracapsular extension of the prostate cancer, with greater than 50% of the number of biopsy cores positive for cancer, metastatic disease, other ongoing cancers which will be treated during the study, or subjects for whom pelvic lymph node radiotherapy is planned
- Subjects with any prior invasive malignancy (except non-melanomatous skin cancer) unless the subject has been disease free for a minimum of 5 years.
- Subjects who are indicated for androgen deprivation therapy or who have been treated with androgen therapy within the prior 3 months.
Data sourced from ClinicalTrials.gov (NCT01538628). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.