SpaceOAR Vue System for Prostate Cancer

(SABRE Trial)

Recruiting at 29 trial locations

Overseen By Gwen LeTourneau

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Boston Scientific Corporation

Disqualifiers: Metastatic disease, Inflammatory bowel disease, Prostatectomy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6-8 weeks

500 Participants Needed

Trial Summary

What is the purpose of this trial?

To demonstrate the effectiveness of the SpaceOAR Vue System in reducing late gastrointestinal (GI) toxicity in subjects undergoing Stereotactic Body Radiotherapy (SBRT) to treat prostate cancer.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on anticoagulants (blood thinners), you may need to stop them for the procedure.

What data supports the effectiveness of the SpaceOAR Vue System treatment for prostate cancer?

Research shows that Stereotactic Body Radiotherapy (SBRT), a component of the treatment, is safe and effective for low- and intermediate-risk prostate cancer, with promising quality of life outcomes. Additionally, Stereotactic Ablative Radiotherapy (SABR) is feasible and well-tolerated for intermediate- and high-risk prostate cancer, although more data is needed for high-risk cases. ^{1 2 3 4 5}

Is the SpaceOAR Vue System safe for use in humans?

Research on stereotactic body radiotherapy (SBRT), which is related to the SpaceOAR Vue System, shows that it is generally safe for treating prostate cancer, with safety established through various clinical trials. ^{2 4 6 7 8}

How is the SpaceOAR Vue System with SBRT treatment for prostate cancer different from other treatments?

The SpaceOAR Vue System with SBRT is unique because it uses an iodinated rectal spacer to protect the rectum during radiation therapy, allowing for more precise targeting of the prostate cancer while minimizing damage to surrounding tissues. This approach is particularly beneficial for patients who cannot undergo MRI, as the spacer is visible on CT scans, aiding in accurate treatment planning. ^{9 10 11 12 13}

Research Team

Suneil Jain, MB, BCh, PhD

Principal Investigator

Queen's University, Belfast

Eligibility Criteria

This trial is for men over 18 with invasive prostate cancer who plan to undergo SBRT. They must have a clinical stage T2b-T2c tumor, Gleason Score of 7, or PSA levels between 10-20 ng/ml. Exclusions include PSA >20 ng/ml, metastatic disease, prior malignancies (unless disease-free for 3 years), previous local prostate treatments or pelvic irradiation, compromised immune systems, large prostates (>80 cc), and certain medical conditions.

Inclusion Criteria

I have been diagnosed with invasive prostate cancer and plan to undergo SBRT.

My prostate cancer is at an intermediate risk level.

I, or my authorized representative, have signed the consent form after understanding the study.

Exclusion Criteria

Known polyethylene glycol (PEG) sensitivity or allergy

My prostate cancer biopsy shows a Gleason Score of 8 or higher.

My PSA level was over 20 ng/ml before starting hormone therapy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Stereotactic Body Radiotherapy (SBRT) with or without the SpaceOAR Vue System

6-8 weeks

Follow-up

Participants are monitored for late gastrointestinal (GI) toxicity and changes in EPIC-26 bowel score

24 months

Treatment Details

Interventions

• SpaceOAR Vue System
• Stereotactic Body Radiotherapy

Trial Overview The SpaceOAR Vue System is being tested to see if it can reduce late gastrointestinal side effects in patients receiving Stereotactic Body Radiotherapy (SBRT) for prostate cancer. The study will involve subjects using the system during their SBRT treatment.

Participant Groups

Group I: SpaceOAR Vue Experimental Treatment 1 Intervention

Subjects will receive radiotherapy following injection of the SpaceOAR Vue hydrogel.

Group II: No-Spacer Control Active Control 1 Intervention

Subjects will receive radiotherapy without the use of the SpaceOAR Vue.

Stereotactic Body Radiotherapy is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Stereotactic Body Radiation Therapy for:

• Lung cancer
• Liver cancer
• Spine tumors
• Pancreatic cancer
• Prostate cancer

Approved in United States as Stereotactic Body Radiation Therapy for:

• Early-stage lung cancer
• Liver cancer
• Spine tumors
• Pancreatic cancer
• Prostate cancer

Approved in Canada as Stereotactic Body Radiation Therapy for:

• Lung cancer
• Liver cancer
• Spine tumors
• Pancreatic cancer
• Prostate cancer

Approved in Japan as Stereotactic Body Radiation Therapy for:

• Lung cancer
• Liver cancer
• Spine tumors
• Pancreatic cancer
• Prostate cancer

Who Is Running the Clinical Trial?

Boston Scientific Corporation

Lead Sponsor

Trials

758

Recruited

867,000+

Michael F. Mahoney

Boston Scientific Corporation

Chief Executive Officer since 2016

MBA from Wake Forest University, BBA in Finance from the University of Iowa

Kenneth Stein

Boston Scientific Corporation

Chief Medical Officer since 2020

MD from Harvard Medical School, MMSc in Clinical Investigation from Harvard-MIT Division of Health Sciences and Technology

Findings from Research

Stereotactic body radiotherapy (SBRT) for low- and intermediate-risk prostate cancer patients was found to be safe and well-tolerated, with mild acute toxicity reported in only a small number of cases (23 out of 72 for rectal and 50 out of 72 for urinary issues).

Patient-reported quality of life remained stable over the first year post-treatment, with minimal changes in urinary, rectal, sexual, and hormonal scores, indicating that SBRT does not significantly impact these aspects of life in the short term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy with flattening filter-free beams for prostate cancer: assessment of patient-reported quality of life. Scorsetti, M., Alongi, F., Clerici, E., et al.[2021]

In a phase I/II clinical trial involving 91 prostate cancer patients, stereotactic body radiation therapy (SBRT) demonstrated excellent long-term efficacy, with a 98.6% freedom from biochemical failure at 5 years and 100% distant metastasis-free survival.

While SBRT was effective, higher doses (greater than 47.5 Gy) were associated with increased severe late toxicity, highlighting the need for careful dose management to minimize adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiation therapy for low and intermediate risk prostate cancer-Results from a multi-institutional clinical trial. Hannan, R., Tumati, V., Xie, XJ., et al.[2022]

Stereotactic ablative radiotherapy (SABR) has been shown to be feasible and well tolerated for low- and intermediate-risk prostate cancer patients, with promising results from large randomized studies comparing it to conventional treatments.

While SABR shows potential benefits and cost-effectiveness, there is currently insufficient data to recommend its use for high-risk prostate cancer patients outside of clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Ablative Body Radiotherapy for Intermediate- or High-Risk Prostate Cancer. Loblaw, A.[2021]

In a study of 84 low-risk prostate cancer patients treated with Stereotactic Ablative Body Radiotherapy (SABR), long-term quality of life (QOL) outcomes were generally positive, with a median follow-up of 50.8 months, although some patients reported declines in urinary (17.9%), bowel (26.2%), and sexual (37.5%) QOL domains.

Dosimetric factors such as rectal D1cc and penile bulb V35 were identified as significant predictors of worse QOL, highlighting the importance of adhering to strict dosimetric constraints to minimize side effects from treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dosimetric and patient correlates of quality of life after prostate stereotactic ablative radiotherapy. Elias, E., Helou, J., Zhang, L., et al.[2018]

A single session of stereotactic ablative body radiotherapy (SABR) for oligometastatic prostate cancer was found to be feasible and safe, with only one significant adverse event (a vertebral fracture) reported among 33 patients over a 2-year follow-up period.

The treatment resulted in high local progression-free survival rates of 97% at 1 year and 93% at 2 years, with nearly half of the patients (48%) avoiding the need for androgen deprivation therapy at the 2-year mark, indicating effective disease control and maintained quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Abative Body Radiotherapy (SABR) for Oligometastatic Prostate Cancer: A Prospective Clinical Trial. Siva, S., Bressel, M., Murphy, DG., et al.[2022]

Stereotactic body radiotherapy (SBRT) is shown to be safe and effective for treating node-positive prostate cancer, with a median follow-up of 30 months revealing no severe gastrointestinal toxicities and manageable genitourinary side effects.

In a study of 60 patients, SBRT resulted in a 3-year overall survival rate of 89% and a biochemical failure-free survival rate of 77%, indicating promising long-term outcomes even in patients with advanced disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Ultra-hypofractionation in Node-positive Prostate Cancer. Telkhade, T., Murthy, V., Kanala, TS., et al.[2021]

CyberKnife stereotactic ablative radiotherapy (SABR) for treating intermediate- to very-high-risk prostate cancer showed a high 3-year biochemical relapse-free survival rate of 90.2%, indicating its efficacy in managing this condition.

The treatment was well-tolerated, with no patients experiencing severe toxicity (≥ grade 3), and only mild genitourinary and gastrointestinal side effects were reported, suggesting a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiotherapy with CyberKnife in the treatment of locally advanced prostate cancer: preliminary results. Fan, CY., Chao, HL., Huang, WY., et al.[2017]

In a prospective phase II trial involving 110 patients aged 70 and older with localized prostate cancer, stereotactic body radiotherapy (SBRT) demonstrated a severe toxicity rate of less than 5%, confirming its safety for this patient population.

The SBRT regimen resulted in a biochemical progression-free survival (bPFS) rate of 90% over a median follow-up of 36 months, indicating its efficacy in treating localized prostate cancer without negatively impacting patients' quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective validation of stringent dose constraints for prostatic stereotactic radiation monotherapy: results of a single-arm phase II toxicity-oriented trial. Nguyen, P., Harzée, L., Retif, P., et al.[2022]

The use of SpaceOAR Vue™, an iodinated rectal spacer, during Robotic Stereotactic Body Radiation Therapy (SBRT) for a prostate cancer patient helped mitigate the risk of radiation proctitis, especially important given the patient's contraindication to MRI and anticoagulant use.

This case highlights the technical aspects of safely placing the spacer and planning treatment, demonstrating its potential to improve treatment outcomes for patients at higher risk of rectal complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utilization of Iodinated SpaceOAR Vue™ During Robotic Prostate Stereotactic Body Radiation Therapy (SBRT) to Identify the Rectal-Prostate Interface and Spare the Rectum: A Case Report. Conroy, D., Becht, K., Forsthoefel, M., et al.[2021]

In a study of 50 men with low- or intermediate-risk prostate cancer, the use of a periprostatic hydrogel spacer (SpaceOAR) during stereotactic body radiotherapy (SBRT) resulted in minimal gastrointestinal toxicity and no severe adverse effects, indicating a safe treatment approach.

The treatment led to favorable oncologic outcomes, with no recorded PSA failures and a median PSA level of 0.9 ng/mL at 20 months post-treatment, demonstrating the efficacy of SBRT combined with the hydrogel spacer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy with periprostatic hydrogel spacer for localized prostate cancer: toxicity profile and early oncologic outcomes. Hwang, ME., Mayeda, M., Liz, M., et al.[2020]

The SpaceOAR® Hydrogel system is effective in reducing radiation exposure to the rectum during prostate cancer treatment, as demonstrated in a case involving a 74-year-old male with intermediate-risk prostate cancer.

However, this case also highlights a potential complication, as the patient developed a bladder stone containing the hydrogel 14 months post-treatment, indicating the need for careful monitoring after its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bladder stone formation around polyethylene glycol after use of SpaceOAR Hydrogel. Tanaka, G., Tsuboi, I., Mitani, K., et al.[2023]

In a study of 59 patients with localized prostate cancer, the use of SpaceOAR Hydrogel during radiation therapy resulted in significant declines in prostate-specific antigen levels without causing any grade 3 toxicities, indicating a safe profile for this intervention.

Quality of life, as measured by patient-reported outcomes, remained stable throughout the study, with no significant changes in urinary or bowel symptoms, suggesting that SpaceOAR effectively protects critical organs during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Reported Quality of Life Outcomes After Definitive Radiation Therapy With Absorbable Spacer Hydrogel for Prostate Cancer. Newman, NB., Rajkumar, A., Cleary, RK., et al.[2023]

In a case series of 13 prostate cancer patients treated with low-dose-rate brachytherapy, the use of SpaceOAR Vue™, a new iodinated hydrogel rectal spacer, improved the visibility of the rectal wall during treatment planning, which is crucial for minimizing rectal toxicity.

The study highlights that SpaceOAR Vue™ can enhance the accuracy of dosimetry in brachytherapy, potentially leading to safer and more effective treatment outcomes for patients at various risk levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Case Report: Role of an Iodinated Rectal Hydrogel Spacer, SpaceOAR Vue™, in the Context of Low-Dose-Rate Prostate Brachytherapy, for Enhanced Post-Operative Contouring to Aid in Accurate Implant Evaluation and Dosimetry. Gross, A., Yuan, J., Spratt, D., et al.[2022]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy with flattening filter-free beams for prostate cancer: assessment of patient-reported quality of life. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Stereotactic body radiation therapy for low and intermediate risk prostate cancer-Results from a multi-institutional clinical trial. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Stereotactic Ablative Body Radiotherapy for Intermediate- or High-Risk Prostate Cancer. [2021]

4. Ireland pubmed.ncbi.nlm.nih.gov

Dosimetric and patient correlates of quality of life after prostate stereotactic ablative radiotherapy. [2018]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Stereotactic Abative Body Radiotherapy (SABR) for Oligometastatic Prostate Cancer: A Prospective Clinical Trial. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Ultra-hypofractionation in Node-positive Prostate Cancer. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiotherapy with CyberKnife in the treatment of locally advanced prostate cancer: preliminary results. [2017]

8. Germany pubmed.ncbi.nlm.nih.gov

Prospective validation of stringent dose constraints for prostatic stereotactic radiation monotherapy: results of a single-arm phase II toxicity-oriented trial. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Utilization of Iodinated SpaceOAR Vue™ During Robotic Prostate Stereotactic Body Radiation Therapy (SBRT) to Identify the Rectal-Prostate Interface and Spare the Rectum: A Case Report. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy with periprostatic hydrogel spacer for localized prostate cancer: toxicity profile and early oncologic outcomes. [2020]

11. Australia pubmed.ncbi.nlm.nih.gov

Bladder stone formation around polyethylene glycol after use of SpaceOAR Hydrogel. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Patient Reported Quality of Life Outcomes After Definitive Radiation Therapy With Absorbable Spacer Hydrogel for Prostate Cancer. [2023]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Case Report: Role of an Iodinated Rectal Hydrogel Spacer, SpaceOAR Vue™, in the Context of Low-Dose-Rate Prostate Brachytherapy, for Enhanced Post-Operative Contouring to Aid in Accurate Implant Evaluation and Dosimetry. [2022]