SpaceIT Hydrogel System for Prostate Cancer

(HYDROSPACE Trial)

Recruiting at 13 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

Trial Summary

What is the purpose of this trial?

To evaluate the safety and effectiveness of the SpaceIT™ Hydrogel System in patients undergoing External Beam Radiotherapy (EBRT) for the treatment of 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 pause them for the procedure.

What data supports the effectiveness of the SpaceIT Hydrogel System treatment for prostate cancer?

The research highlights that hydrogels, similar to the SpaceIT Hydrogel System, can maintain prostate cancer cell viability and support drug testing, suggesting potential effectiveness in creating a supportive environment for prostate cancer treatment. Additionally, hydrogels have been shown to inhibit prostate cancer cell growth and support nerve regeneration, which may help manage side effects of prostate cancer treatments. ^{1 2 3 4 5}

Is the SpaceIT Hydrogel System safe for use in humans?

The SpaceOAR Hydrogel System, used to create space between the prostate and rectum during radiotherapy, has been generally safe in clinical trials, but some serious complications have been reported, such as pain, infection, and rare cases of severe reactions like anaphylaxis and rectal injury. ^{6 7 8 9 10}

How is the SpaceIT Hydrogel System treatment for prostate cancer different from other treatments?

The SpaceIT Hydrogel System is unique because it uses a hydrogel to create a physical space between the prostate and surrounding tissues, which helps protect healthy tissues during radiation therapy. This approach is different from traditional treatments that do not use such a protective barrier, potentially reducing side effects and improving patient outcomes. ^{2 3 5 11 12}

Research Team

Brian C Baumann

Principal Investigator

Springfield Clinic

Eligibility Criteria

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 PSA levels were 20 ng/ml or less before starting hormone therapy.

Timeline

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)

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

3D bioprinting of multi-cellular tumor microenvironment for prostate cancer metastasis. [2023]

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

Hydrogel-based 3D model of patient-derived prostate xenograft tumors suitable for drug screening. [2021]

3. Netherlands 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. [2022]

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

Prostate carcinoma cell growth-inhibiting hydrogel supports axonal regeneration in vitro. [2013]

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

Phenotypic characterization of prostate cancer LNCaP cells cultured within a bioengineered microenvironment. [2022]

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

Absorbable Hydrogel Spacer Use in Prostate Radiotherapy: A Comprehensive Review of Phase 3 Clinical Trial Published Data. [2018]

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

Continued Benefit to Rectal Separation for Prostate Radiation Therapy: Final Results of a Phase III Trial. [2022]

8. United States 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. [2020]

9. Australia pubmed.ncbi.nlm.nih.gov

Spontaneous remission of rectal ulcer associated with SpaceOAR® hydrogel insertion in radiotherapy for prostate cancer. [2022]

10. 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]

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

Capillary force seeding of sphere-templated hydrogels for tissue-engineered prostate cancer xenografts. [2021]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Recreating the tumor microenvironment in a bilayer, hyaluronic acid hydrogel construct for the growth of prostate cancer spheroids. [2022]