Any reports on using the SpaceOar

You are right that drop-outs/non-compliance are always a concern, and they are usually reported. I don't recall offhand the % who didn't fill out the questionnaire by the end, but it doesn't stick in my mind as a particular issue. The very fact of having a clinical trial usually means that extra attention is paid and patients are getting extraordinary care, so outcomes are often better than in the real world.

What may be an issue here is that neither the participants and physicians were blinded. This means that those who got the spacer may have received special care in the planning that the control group did not. And patients may not wish to displease their doctors. That's why I found the reduction in urinary SEs troubling. A spacer at the rectum should have had no effect on urinary function. It would be like putting sunblock on your face and perceiving less sunburn on your chest. I think Dr Kang's RCT will be informative. I tried to convince her to have a third group who was given neither spacer nor balloon, but she will just rely on historical controls. It would be interesting to have a group who gets both too.

Looks like another SpaceOAR data dump...

From Imaging Technology News September 22, 2017 —

Augmenix Inc. announced a preview of clinical data that will be presented at the 59th Annual Meeting of the American Society for Radiation Oncology (ASTRO 2017), Sept. 24-27 in San Diego. The presentations will provide new insights on the clinical and quality of life benefits of the company’s novel absorbable hydrogel spacing technology in providing protection during radiation therapy.

SpaceOAR hydrogel, Augmenix’s lead product, is U.S. Food and Drug Administration (FDA)-cleared and is designed to protect the rectum in men undergoing radiation therapy for prostate cancer.

Most notably at ASTRO 2017, results from the first prospective study evaluating the efficacy of SpaceOAR hydrogel in patients undergoing high-dose stereotactic body radiation therapy (SBRT) for prostate cancer will be presented as a late-breaking clinical trial on Tuesday, Sept. 26. Additionally, the first five-year quality of life data results in prostate cancer patients treated with SpaceOAR hydrogel will unveiled the same day in an oral presentation, demonstrating significant bowel and sexual function benefits. A didactic industry-sponsored panel discussion on the present and future role of hydrogel spacing in the treatment of prostate cancer, led by renowned radiation oncologists from around the world, will occur on Monday, Sept. 25.

Following is a detailed schedule of the company’s events in chronological order (times are U.S. Pacific Daylight Time):


Sunday, September 24

The following poster presentations will take place from 1:15 p.m. – 2:45 p.m. in the Poster Hall:

Poster Presentation (No : 2559): Dosimetry for Organs at Risk With and Without Use of Perirectal Hydrogel Spacer in Prostate Cancer Patients Treated With SBRT
Presented by: Daniel B. Fried, M.D., Ph.D., MPH

Poster Presentation (No : 2572): A Pilot Study – The Role of Radio-Opaque Hydrogel Tissue Marker in the Treatment of Postprostatectomy Intensity Modulated Radiation Therapy
Presented by Huong Ho, DO

Poster Presentation (No : 3383): Updated Retrospective Dose Volume Histogram Analysis of High Dose Rate Prostate Brachytherapy Patients With Hydrogel Spacer Implantation
Presented by Sean Cavanaugh, M.D.


Monday, September 25

Industry-Expert Theatre: Present and Future Role of Hydrogel Spacing in the Treatment of Prostate Cancer – 3 & 5 Year QOL Evidence and Stereotactic Body Radiation Therapy (SBRT) Experience
Time/location: 12:30 p.m. – 1:30 p.m. Exhibit Hall – Theatre 1
Speakers: Robert Timmerman, M.D., professor of radiation oncology and neurology at the University of Texas Southwestern Medical Center in Dallas; Michael Zelefsky, M.D., professor of radiation oncology, vice-chair of the Department of Radiology and chief of the Brachytherapy Service at Memorial Sloan-Kettering Cancer Center in New York City; Daniel Hamstra, M.D., Ph.D., clinical director and professor at William Beaumont Oakland University Medical School, Department of Radiation Oncology, Beaumont Health, Dearborn, Mich.; and Prof. Dr. Michael Pinkawa, director of the Department of Radiation Oncology, MediClin Robert Janker Klinik in Bonn, Germany.
Moderator: Rodney Ellis, M.D., vice chair for clinical affairs at the University Hospitals Cleveland Medical Center and associate professor, radiation oncology at Case Western Reserve University in Cleveland.

Poster Presentation (No : 3613): The Rectal Dosimetric Effects of Perirectal Hydrogel Spacers in Men Undergoing Prostate Stereotactic Body Radiation Therapy (SBRT)
Time/location: 4:15 p.m. – 5:45 p.m. Poster Hall
Presenter: Shaan Kataria, M.D.


Tuesday, September 26

Late-Breaking Abstracts Special Session (SS 22): Multi-Institutional Phase 2 Trial of High-Dose Stereotactic Body Radiation Therapy with Temporary Hydrogel Spacer for Low- and Intermediate-Risk Prostate Cancer
Time/location: 7:45 a.m. – 9 a.m. Room 5A
Presenter: Michael Folkert, M.D.

ePoster Presentation (No: 1083): Quality of Life after Radiation Therapy for Prostate Cancer With a Hydrogel Spacer: Five Year Results
Time/location: 1:12 p.m. Room 5B
Presenter: Michael Pinkawa, M.D., Ph.D.

Just want to add that you must make sure that the person who is doing the injection must have done a minimum of 15.
I had an injection on August 30th, the entire gel was out of place rendered it useless. Meanwhile the insurance was billed $9490.50, amount allowed was $2,847.15, my portion was $569.43.

In its own study, almost half of the injections had an off center distribution. Their study claimed that even the off center distribution of hydro gel provided significant benefits to the patients. I wonder how many patients are aware of this issue.