SpaceIT Hydrogel System for Prostate Cancer

(HYDROSPACE Trial)

Recruiting at 27 trial locations

Overseen By Kaitlyn Rainbow

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Boston Scientific Corporation

Disqualifiers: Metastatic disease, Other cancers, Others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

230 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of a new gel, the SpaceIT Hydrogel System, used during radiation therapy for prostate cancer. The gel protects healthy tissues around the prostate while targeting cancer cells. Participants will receive either this new gel or the existing option, SpaceOAR, to compare outcomes. Men with prostate cancer planning to undergo external beam radiation therapy and meeting specific health criteria might be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance future prostate cancer treatments.

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 pause them for the procedure.

What prior data suggests that the SpaceIT Hydrogel System is safe for patients undergoing EBRT for prostate cancer?

Studies have shown that hydrogel spacers like the SpaceIT Hydrogel System are generally safe for treating prostate cancer. Research indicates these spacers have a low complication rate of 0.96%. Notably, no serious stomach or intestinal problems were reported, indicating they are well-tolerated. This suggests the SpaceIT Hydrogel System is likely safe for individuals considering joining this clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

The SpaceIT Hydrogel System is unique because it offers a new approach to prostate cancer treatment by creating a protective barrier between the prostate and surrounding tissues during radiation therapy. This hydrogel system aims to reduce radiation exposure to nearby organs, potentially minimizing side effects compared to current options like the commercially available SpaceOAR device. Researchers are excited because this could lead to improved patient comfort and safety during treatment, offering a more precise and less invasive method for managing prostate cancer.

What evidence suggests that the SpaceIT Hydrogel System is effective for prostate cancer?

This trial will compare the SpaceIT Hydrogel System with the commercially available Boston Scientific Spacer. Research shows that the SpaceIT Hydrogel System creates a gap between the prostate and rectum during radiation treatment for prostate cancer, helping to protect the rectum from radiation and reduce side effects. Studies on similar products, such as SpaceOAR, have demonstrated a significant decrease in complications. Specifically, one study showed a 79% reduction in the amount of radiation the rectum received at certain levels. These findings suggest that hydrogel spacers can effectively lower the risk of rectal damage during prostate cancer treatment. ^{6 7 8 9 10}

Who Is on the Research Team?

Brian C Baumann

Principal Investigator

Springfield Clinic

Are You a Good Fit for This Trial?

This trial is for men over 18 with early-stage prostate cancer (stage T1-T2c, Gleason Score ≤7) who are planning to undergo external beam radiotherapy. They must have a PSA level ≤20 ng/ml and confirmed invasive adenocarcinoma of the prostate. Participants need to provide consent and meet other specific health criteria.

Inclusion Criteria

I have been diagnosed with invasive prostate cancer and will undergo external beam radiation therapy.

My prostate cancer Gleason Score is 7 or less, based on a recent biopsy.

My cancer is in an early stage and has not spread deeply.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Hydrogel Placement Procedure

Participants undergo a hydrogel procedure with either the SpaceIT investigational device or a commercially available Boston Scientific spacer

1 day

1 visit (in-person)

Radiotherapy

Participants receive External Beam Radiotherapy (EBRT) for prostate cancer treatment

6-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of adverse events and quality of life

24 months

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• SpaceIT Hydrogel System

Trial Overview The SpaceIT Hydrogel System is being tested against a commercially available Boston Scientific Spacer in patients receiving radiation therapy for prostate cancer. The goal is to assess the safety and effectiveness of this new system in creating space around the rectum during treatment.

How Is the Trial Designed?

Group I: SpaceIT Hydrogel System Experimental Treatment 1 Intervention

Subjects randomized to the investigational arm will undergo a hydrogel procedure with the SpaceIT investigational device.

Group II: Commercially available Boston Scientific Spacer Active Control 1 Intervention

Subjects randomized to the control arm will undergo a hydrogel procedure with the Boston Scientific commercially available SpaceOAR or SpaceOAR VUE device.

SpaceIT Hydrogel System is already approved in United States for the following indications:

Approved in United States as SpaceOAR Hydrogel System for:

• 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

Published Research Related to This Trial

The engineered 3D hydrogel system successfully supports the co-culture of prostate cancer patient-derived xenograft (PDX) cells and osteoblastic cells, effectively mimicking the tumor-stromal interactions found in bone metastasis.

This model not only maintains cell viability and the osteogenic phenotype of PDX cells but also demonstrates that the interaction between prostate cancer cells and osteoblasts promotes cancer progression, making it a valuable tool for studying prostate cancer bone metastasis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A 3D in vitro model of patient-derived prostate cancer xenograft for controlled interrogation of in vivo tumor-stromal interactions. Fong, EL., Wan, X., Yang, J., et al.[2022]

The study developed a hyaluronic acid-based bilayer hydrogel system that effectively supports the formation of tumoroids from LNCaP prostate cancer cells, simulating their interactions with surrounding tumor-associated stroma.

Culturing cancer cells in this 3D hydrogel led to significant increases in pro-angiogenic factors like VEGF(165) and IL-8, highlighting the model's potential for studying tumor responses and screening anticancer drugs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recreating the tumor microenvironment in a bilayer, hyaluronic acid hydrogel construct for the growth of prostate cancer spheroids. Xu, X., Gurski, LA., Zhang, C., et al.[2022]

The study developed a patient-derived xenograft (PDX) model of bone metastatic prostate cancer using immunocompromised mice, which better mimics the disease compared to traditional cell lines.

Encapsulating PDX tumor cells in a three-dimensional hyaluronan-based hydrogel preserved cell viability and androgen receptor expression, allowing for more accurate drug sensitivity testing, such as the differential response to docetaxel compared to standard cell lines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hydrogel-based 3D model of patient-derived prostate xenograft tumors suitable for drug screening. Fong, EL., Martinez, M., Yang, J., et al.[2021]

In a study of 222 men undergoing radiation therapy for prostate cancer, the use of the SpaceOAR hydrogel significantly reduced the incidence of rectal toxicity, with grade ≥1 toxicity occurring in 2.0% of the spacer group compared to 9.2% in the control group after 3 years.

Quality of life assessments showed that the spacer group experienced less decline in bowel and urinary quality of life compared to the control group, with significant differences in bowel quality of life meeting the threshold for clinical importance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continued Benefit to Rectal Separation for Prostate Radiation Therapy: Final Results of a Phase III Trial. Hamstra, DA., Mariados, N., Sylvester, J., et al.[2022]

A new capillary force-based method for seeding prostate cancer cells into hydrogels significantly improved cell distribution and numbers compared to traditional methods like static and centrifugation seeding.

While the cells proliferated well within the hydrogels, a necrotic zone developed after 7 days due to limited oxygen and nutrient diffusion, which could be mitigated by using dynamic culture methods like orbital shaking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Capillary force seeding of sphere-templated hydrogels for tissue-engineered prostate cancer xenografts. Long, TJ., Takeno, M., Sprenger, CC., et al.[2021]

SpaceOAR® hydrogel injection, approved by the FDA, effectively reduces rectal radiation exposure during prostate radiotherapy, leading to lower rates of rectal toxicity, but remains in early clinical use with emerging safety concerns.

A review of safety reports revealed serious complications associated with SpaceOAR, including acute pulmonary embolism and rectal wall erosion, indicating a need for ongoing monitoring and further research as its use becomes more widespread.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Major Complications and Adverse Events Related to the Injection of the SpaceOAR Hydrogel System Before Radiotherapy for Prostate Cancer: Review of the Manufacturer and User Facility Device Experience Database. Aminsharifi, A., Kotamarti, S., Silver, D., et al.[2020]

The SpaceOAR® hydrogel system, designed to protect the rectum during prostate radiotherapy, can potentially cause rectal toxicity, as evidenced by a case where a 75-year-old man developed a rectal ulcer after its insertion.

Post-implant magnetic resonance imaging (MRI) was effective in detecting hydrogel infiltration into the rectum, suggesting that MRI could be a valuable follow-up tool to monitor for complications related to SpaceOAR® hydrogel use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spontaneous remission of rectal ulcer associated with SpaceOAR® hydrogel insertion in radiotherapy for prostate cancer. Imai, K., Sakamoto, H., Akahane, M., et al.[2022]

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]

Using bioengineered polyethylene glycol (PEG) hydrogels with adjustable properties, researchers found that LNCaP prostate cancer cells exhibited different growth patterns and formed tumor-like structures over 28 days compared to traditional 2D cultures.

The study revealed that the response of LNCaP cells to androgen stimulation varied significantly between 2D and 3D cultures, indicating that 3D environments better mimic the tumor microenvironment and could enhance drug testing for prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phenotypic characterization of prostate cancer LNCaP cells cultured within a bioengineered microenvironment. Sieh, S., Taubenberger, AV., Rizzi, SC., et al.[2022]

The SpaceOAR hydrogel spacer is a safe and well-tolerated procedure with a 99% technical success rate, effectively creating over 1 cm of space between the prostate and rectum, which significantly reduces rectal radiation exposure during prostate cancer treatment.

Patients receiving the hydrogel spacer experienced lower rates of acute and long-term rectal toxicity, as well as improved bowel, urinary, and sexual quality of life, with notable improvements in sexual function observed at 37 months post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Absorbable Hydrogel Spacer Use in Prostate Radiotherapy: A Comprehensive Review of Phase 3 Clinical Trial Published Data. Karsh, LI., Gross, ET., Pieczonka, CM., et al.[2018]

The study developed a novel bioink using gelatin methacryloyl/chondroitin sulfate-based hydrogels combined with hyaluronic acid (HA) to create a 3D coculture model for investigating prostate cancer (PCa) behaviors.

Findings revealed that HA not only promotes PCa cell proliferation and metastasis but also induces normal fibroblasts to transform into cancer-associated fibroblasts (CAFs), which enhances drug resistance and further metastasis in PCa.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

3D bioprinting of multi-cellular tumor microenvironment for prostate cancer metastasis. Xu, K., Huang, Y., Wu, M., et al.[2023]

An injectable hydrogel made from hydrolyzed collagen shows promise as a regenerative matrix for patients after radical prostatectomy, adapting to tissue shapes and promoting healing without affecting nerve growth.

The hydrogel can also deliver a chemotherapeutic drug that inhibits harmful cell growth while preserving the health of nerve cells, suggesting it could help prevent complications like fibrosis and tumor relapse after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prostate carcinoma cell growth-inhibiting hydrogel supports axonal regeneration in vitro. Franke, K., Baur, M., Daum, L., et al.[2013]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06451614

SpaceIT Hydrogel System for Perirectal Spacing SpaceIT Hydrogel System is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in ...

2. spaceoar.com spaceoar.com/us/en/about-spaceoar-hydrogel/clinically-proven-results.html

SpaceOAR™ Hydrogel Clinical Trial | FDA Cleared Clinically proven results · Fewer sexual complications · Fewer urinary complications · Fewer bowel complications · Learn what doctors are saying about SpaceOAR.

3. bostonscientific.com bostonscientific.com/en-US/medical-specialties/urology/prostate-health/prostate-cancer/spaceoar-hydrogel/physicians-perspectives/spaceoar-hydrogel-clinical-evidence.html

Clinical Evidence Over Years - SpaceOAR Hydrogel In fact, the dosimetric results showed that the rectal V50 thru V80 was significantly reduced — with a 79 percent reduction in the V70.4 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8627770/

Clinical Outcomes of Hydrogel Spacer Injection Space ... The use of a hydrogel spacer (Space OAR) between the rectum and the prostate has been approved to reduce rectal toxicity in prostate radiation therapy.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2452109425001113

Analysis of The FDA Manufacturer and User Facility Device ... Clinical trials have shown that hydrogel spacers provide a low morbidity method for reducing rectal toxicity following radiation therapy in men ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06451614

SpaceIT Hydrogel System for Perirectal Spacing SpaceIT Hydrogel System is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in ...

7. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/499978

SpaceIT Hydrogel System for Perirectal Spacing SpaceIT Hydrogel System is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer.

8. bostonscientific.com bostonscientific.com/content/dam/bostonscientific/uro-mh/resources/spaceoar-hydrogel/showcase/clinical-evidence/spaceOAR-metaanalysis-RT-evidence.pdf

SpaceOAR™ Hydrogel is Associated with Lower Rectal ... Among men planning to receive radiotherapy for localised or locally advanced prostate cancer, injection of a SpaceOAR Hydrogel was safe, provided prostate- ...

9. uclahealth.org uclahealth.org/clinical-trials/spaceit-hydrogel-system-perirectal-spacing

SpaceIT Hydrogel System for Perirectal Spacing To evaluate the safety and effectiveness of the SpaceIT™ Hydrogel System in ... History of radical prostatectomy, other ablative anti-prostate cancer ...

10. sciencedirect.com sciencedirect.com/science/article/pii/S1879850025000955

Implantable Rectal Spacers in Prostate Cancer Radiation ... Findings indicate a favorable safety profile, with an overall complication rate of 0,96% when using hydrogel spacers. There was no grade 4 to 5 gastrointestinal ...