SpaceIT Hydrogel System for Prostate Cancer
(HYDROSPACE Trial)
Recruiting in Palo Alto (17 mi)
+8 other locations
Age: 18+
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Boston Scientific Corporation
Disqualifiers: Metastatic disease, Other cancers, Others
No Placebo Group
Approved in 1 Jurisdiction
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.
12345Is 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.
678910How 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.
2351112Eligibility 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 am 18 years old or older.
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.
+3 more
Trial 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)
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: SpaceIT Hydrogel SystemExperimental Treatment1 Intervention
Subjects randomized to the investigational arm will undergo a hydrogel procedure with the SpaceIT investigational device.
Group II: Commercially available Boston Scientific SpacerActive Control1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Baptist Hospital of MiamiMiami, FL
Evergreen Hospital Medical CenterKirkland, WA
Springfield Clinic, LLCSpringfield, IL
Perlmutter Cancer Center - NYU LangoneNew York, NY
More Trial Locations
Loading ...
Who Is Running the Clinical Trial?
Boston Scientific CorporationLead Sponsor
References
3D bioprinting of multi-cellular tumor microenvironment for prostate cancer metastasis. [2023]Prostate cancer (PCa) is one of the most lethal cancers in men worldwide. The tumor microenvironment (TME) plays an important role in PCa development, which consists of tumor cells, fibroblasts, endothelial cells, and extracellular matrix (ECM). Hyaluronic acid (HA) and cancer-associated fibroblasts (CAFs) are the major components in the TME and are correlated with PCa proliferation and metastasis, while the underlying mechanism is still not fully understood due to the lack of biomimetic ECM components and coculture models. In this study, gelatin methacryloyl/chondroitin sulfate-based hydrogels were physically crosslinked with HA to develop a novel bioink for the three-dimensional bioprinting of a coculture model that can be used to investigate the effect of HA on PCa behaviors and the mechanism underlying PCa-fibroblasts interaction. PCa cells demonstrated distinct transcriptional profiles under HA stimulation, where cytokine secretion, angiogenesis, and epithelial to mesenchymal transition were significantly upregulated. Further coculture of PCa with normal fibroblasts activated CAF transformation, which could be induced by the upregulated cytokine secretion of PCa cells. These results suggested HA could not only promote PCa metastasis individually but also induce PCa cells to activate CAF transformation and form HA-CAF coupling effects to further promote PCa drug resistance and metastasis.
Hydrogel-based 3D model of patient-derived prostate xenograft tumors suitable for drug screening. [2021]The lack of effective therapies for bone metastatic prostate cancer (PCa) underscores the need for accurate models of the disease to enable the discovery of new therapeutic targets and to test drug sensitivities of individual tumors. To this end, the patient-derived xenograft (PDX) PCa model using immunocompromised mice was established to model the disease with greater fidelity than is possible with currently employed cell lines grown on tissue culture plastic. However, poorly adherent PDX tumor cells exhibit low viability in standard culture, making it difficult to manipulate these cells for subsequent controlled mechanistic studies. To overcome this challenge, we encapsulated PDX tumor cells within a three-dimensional hyaluronan-based hydrogel and demonstrated that the hydrogel maintains PDX cell viability with continued native androgen receptor expression. Furthermore, a differential sensitivity to docetaxel, a chemotherapeutic drug, was observed as compared to a traditional PCa cell line. These findings underscore the potential impact of this novel 3D PDX PCa model as a diagnostic platform for rapid drug evaluation and ultimately push personalized medicine toward clinical reality.
A 3D in vitro model of patient-derived prostate cancer xenograft for controlled interrogation of in vivo tumor-stromal interactions. [2022]Patient-derived xenograft (PDX) models better represent human cancer than traditional cell lines. However, the complex in vivo environment makes it challenging to employ PDX models to investigate tumor-stromal interactions, such as those that mediate prostate cancer (PCa) bone metastasis. Thus, we engineered a defined three-dimensional (3D) hydrogel system capable of supporting the co-culture of PCa PDX cells and osteoblastic cells to recapitulate the PCa-osteoblast unit within the bone metastatic microenvironment in vitro. Our 3D model not only maintained cell viability but also preserved the typical osteogenic phenotype of PCa PDX cells. Additionally, co-culture cellularity was maintained over that of either cell type cultured alone, suggesting that the PCa-osteoblast cross-talk supports PCa progression in bone, as is hypothesized to occur in patients with prostatic bone metastasis. Strikingly, osteoblastic cells co-cultured with PCa PDX tumoroids organized around the tumoroids, closely mimicking the architecture of PCa metastases in bone. Finally, tumor-stromal signaling mediated by the fibroblast growth factor axis tightly paralleled that in the in vivo counterpart. Together, these findings indicate that this 3D PCa PDX model recapitulates important pathological properties of PCa bone metastasis, and validate the use of this model for controlled and systematic interrogation of complex in vivo tumor-stromal interactions.
Prostate carcinoma cell growth-inhibiting hydrogel supports axonal regeneration in vitro. [2013]Prostate cancer is the most common malignant tumor in men. Radical prostatectomy, the most common surgical therapy, is typically accompanied by erectile dysfunction and incontinence due to severing of the axons of the plexus prostaticus. To date, no reconstructive therapy is available as the delicate network of severed nerve fibers preclude the transplantation of autologous nerves or synthetic tube implants. Here, we present an injectable hydrogel as a regenerative matrix that polymerizes in situ and thus, adapts to any given tissue topography. The two-component hydrogel was synthesized from a hydrolyzed collagen fraction and stabilized by enzymatic crosslinking with transglutaminase. Physical analysis employing osmolarity measurements and cryosectioning revealed an isotonic, microstructured network that polymerized within 2min and displayed pronounced adhesion to abdominal tissue. Cell culturing demonstrated the biocompatibility of the gel and a general permissiveness for various neuronal and non-neuronal cell types. No effect on cell adhesion, survival and proliferation of cells was observed. A chemotherapeutic drug was integrated into the hydrogel to reduce the risk of fibrosis and tumor relapse. Significantly, when the hydrogel was employed as a drug release depot in vitro, aversive fibroblast- and prostate carcinoma cell growth was inhibited, while axonal outgrowth from peripheral nervous system explants remained completely unaffected. Taken together, these results suggest that the gel's adequate viscoelastic properties and porous microstructure, combined with its tissue adhesion and neuritotrophic characteristics in the presence of a cell type-specific cytostatic, may constitute an appropriate hydrogel implant applicable to patients suffering from prostatectomy associated side effects.
Phenotypic characterization of prostate cancer LNCaP cells cultured within a bioengineered microenvironment. [2022]Biophysical and biochemical properties of the microenvironment regulate cellular responses such as growth, differentiation, morphogenesis and migration in normal and cancer cells. Since two-dimensional (2D) cultures lack the essential characteristics of the native cellular microenvironment, three-dimensional (3D) cultures have been developed to better mimic the natural extracellular matrix. To date, 3D culture systems have relied mostly on collagen and Matrigel™ hydrogels, allowing only limited control over matrix stiffness, proteolytic degradability, and ligand density. In contrast, bioengineered hydrogels allow us to independently tune and systematically investigate the influence of these parameters on cell growth and differentiation. In this study, polyethylene glycol (PEG) hydrogels, functionalized with the Arginine-glycine-aspartic acid (RGD) motifs, common cell-binding motifs in extracellular matrix proteins, and matrix metalloproteinase (MMP) cleavage sites, were characterized regarding their stiffness, diffusive properties, and ability to support growth of androgen-dependent LNCaP prostate cancer cells. We found that the mechanical properties modulated the growth kinetics of LNCaP cells in the PEG hydrogel. At culture periods of 28 days, LNCaP cells underwent morphogenic changes, forming tumor-like structures in 3D culture, with hypoxic and apoptotic cores. We further compared protein and gene expression levels between 3D and 2D cultures upon stimulation with the synthetic androgen R1881. Interestingly, the kinetics of R1881 stimulated androgen receptor (AR) nuclear translocation differed between 2D and 3D cultures when observed by immunofluorescent staining. Furthermore, microarray studies revealed that changes in expression levels of androgen responsive genes upon R1881 treatment differed greatly between 2D and 3D cultures. Taken together, culturing LNCaP cells in the tunable PEG hydrogels reveals differences in the cellular responses to androgen stimulation between the 2D and 3D environments. Therefore, we suggest that the presented 3D culture system represents a powerful tool for high throughput prostate cancer drug testing that recapitulates tumor microenvironment.
Absorbable Hydrogel Spacer Use in Prostate Radiotherapy: A Comprehensive Review of Phase 3 Clinical Trial Published Data. [2018]To provide an update on SpaceOAR System, a Food and Drug Administration-approved hydrogel indicated to create distance between the prostate and the rectum which has been studied in phase 2 and 3 clinical trials. Here, we review and summarize these clinical results including the safety of prostate-rectum spacer application technique, the implant quality and resulting rectal dose reduction, acute and long-term rectal, urinary, and sexual toxicity, as well as patient-reported outcomes.
Continued Benefit to Rectal Separation for Prostate Radiation Therapy: Final Results of a Phase III Trial. [2022]SpaceOAR, a Food and Drug Administration-approved hydrogel intended to create a rectal-prostate space, was evaluated in a single-blind phase III trial of image guided intensity modulated radiation therapy. A total of 222 men were randomized 2:1 to the spacer or control group and received 79.2 Gy in 1.8-Gy fractions to the prostate with or without the seminal vesicles. The present study reports the final results with a median follow-up period of 3 years.
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]Purpose: SpaceOAR® is a Food and Drug Administration-approved hydrogel injection used to create space between the prostate and rectum during prostate radiotherapy. It has shown to significantly reduce the rectal radiation dose with lower rates of rectal toxicity. Despite a high safety performance in initial trials, SpaceOAR remains in early clinical use. Thus, we examined emerging safety reports as the system becomes more widely utilized. Methods: We reviewed the SpaceOAR manufacturer website for the safety profile and complications associated with the SpaceOAR hydrogel. We then compared this with reports submitted to the Manufacturer and User Facility Device Experience (MAUDE) database. Results: The manufacturer website reported risks including pain, needle penetration, and/or gel injection into a nearby organ or blood vessel, local inflammation, infection, urinary retention, and local rectal injury or symptoms. There were 22 unique reports discussing 25 patient cases in the MAUDE database from January 2015 to March 2019, with an increasing number of reports each year up through 2018. Unique major complications including acute pulmonary embolism, severe anaphylaxis, prostatic abscess and sepsis, purulent perineal drainage, rectal wall erosion, and rectourethral fistula were reported. Conclusion: Despite well-documented clinical benefits of the SpaceOAR System, there are a number of severe and debilitating complications recently reported in proximity to gel injection. This highlights the need for further study of device complications in light of its increasing clinical use.
Spontaneous remission of rectal ulcer associated with SpaceOAR® hydrogel insertion in radiotherapy for prostate cancer. [2022]Label="INTRODUCTION" NlmCategory="BACKGROUND">The SpaceOAR® hydrogel system separates the prostate and rectum to reduce rectal irradiation during prostate radiotherapy. However, it could induce rectal toxicity.
Patient Reported Quality of Life Outcomes After Definitive Radiation Therapy With Absorbable Spacer Hydrogel for Prostate Cancer. [2023]SpaceOAR is a device approved for conventional radiation in prostate cancer. We sought to observe prospectively how SpaceOAR Hydrogel effected quality of life and dosimetry to organs at risk at our institution.
Capillary force seeding of sphere-templated hydrogels for tissue-engineered prostate cancer xenografts. [2021]Biomaterial-based tissue-engineered tumor models are now widely used in cancer biology studies. However, specific methods for efficient and reliable cell seeding into these and tissue-engineering constructs used for regenerative medicine often remain poorly defined. Here, we describe a capillary force-based method for seeding the human prostate cancer cell lines M12 and LNCaP C4-2 into sphere-templated poly(2-hydroxyethyl methacrylate) hydrogels. The capillary force seeding method improved the cell number and distribution within the porous scaffolds compared to well-established protocols such as static and centrifugation seeding. Seeding efficiency was found to be strongly dependent on the rounded cell diameter relative to the pore diameter and pore interconnect size, parameters that can be controllably modulated during scaffold fabrication. Cell seeding efficiency was evaluated quantitatively using a PicoGreen DNA assay, which demonstrated some variation in cell retention using the capillary force method. When cultured within the porous hydrogels, both cell lines attached and proliferated within the network, but histology showed the formation of a necrotic zone by 7 days likely due to oxygen and nutrient diffusional limitations. The necrotic zone thickness was decreased by dynamically culturing cells in an orbital shaker. Proliferation analysis showed that despite a variable seeding efficiency, by 7 days in culture, scaffolds contained a roughly consistent number of cells as they proliferated to fill the pores of the scaffold. These studies demonstrate that sphere-templated polymeric scaffolds have the potential to serve as an adaptable cell culture substrate for engineering a three-dimensional prostate cancer model.
Recreating the tumor microenvironment in a bilayer, hyaluronic acid hydrogel construct for the growth of prostate cancer spheroids. [2022]Cancer cells cultured in physiologically relevant, three-dimensional (3D) matrices can recapture many essential features of native tumor tissues. In this study, a hyaluronic acid (HA)-based bilayer hydrogel system that not only supports the tumoroid formation from LNCaP prostate cancer (PCa) cells, but also simulates their reciprocal interactions with the tumor-associated stroma was developed and characterized. HA hydrogels were prepared by mixing solutions of HA precursors functionalized with acrylate groups (HA-AC) and reactive thiols (HA-SH) under physiological conditions. The resultant viscoelastic gels have an average elastic modulus of 234 ± 30 Pa and can be degraded readily by hyaluronidase. The orthogonal and cytocompatible nature of the crosslinking chemistry permits facile incorporation of cytokine-releasing particles and PCa cells. In our bilayer hydrogel construct, the top layer contains heparin (HP)-decorated, HA-based hydrogel particles (HGPs) capable of releasing heparin-binding epidermal growth factor-like growth factor (HB-EGF) in a sustained manner at a rate of 2.5 wt%/day cumulatively. LNCaP cells embedded in the bottom layer receive the growth factor signals from the top, and in response form enlarging tumoroids with an average diameter of 85 μm by day 7. Cells in 3D hydrogels assemble into spherical tumoroids, form close cellular contacts through E-cadherin, and show cortical organization of F-actin, whereas those plated as 2D monolayers adopt a spread-out morphology. Compared to cells cultured on 2D, the engineered tumoroids significantly increased the expression of two pro-angiogenic factors, vascular endothelial growth factor-165 (VEGF(165)) and interleukin-8 (IL-8), both at mRNA and protein levels. Overall, the HA model system provides a useful platform for the study of tumor cell responses to growth factors and for screening of anticancer drugs targeting these pathways.