Rectal Spacers for Prostate Cancer

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Advanced Radiation Centers of New York

Must not be taking: Steroids

Disqualifiers: Metastatic disease, Prostatectomy, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This is a prospective clinical study involving up to 150 subjects with localized prostate cancer who are scheduled for radiation treatment with rectal spacer placement. The goal of this clinical trial is to assess the safety and efficacy of perirectal spacers in patients undergoing radiation therapy for the treatment of localized prostate cancer. Study visits: * Screening * Spacer placement * Treatment planning simulation * End of the radiation treatment * 1,3,and 6-months FU visits.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you have active inflammatory bowel disease requiring treatment with steroids, you may not be eligible to participate.

What data supports the idea that Rectal Spacers for Prostate Cancer is an effective treatment?

The available research shows that rectal spacers, like the hydrogel spacer, are effective in reducing the radiation dose to the rectum during prostate cancer treatment. This helps in minimizing the side effects and damage to the rectal area. Studies indicate that these spacers create a physical barrier between the prostate and rectum, which lowers the risk of rectal damage compared to treatments without spacers. This makes the treatment safer and more tolerable for patients. ^{1 2 3 4 5}

What safety data is available for rectal spacers in prostate cancer treatment?

The safety data for rectal spacers, such as the SpaceOAR system, includes findings from phase 2 and 3 clinical trials. These studies have evaluated the safety of the application technique, implant quality, and the resulting reduction in rectal dose. They have also assessed acute and long-term rectal, urinary, and sexual toxicity, as well as patient-reported outcomes. While the hydrogel spacer is generally effective in reducing rectal dose during radiotherapy, there are reports of complications such as rectal ulcers, which can be severe in some cases. Overall, the safety profile is supported by prospective randomized controlled trials, but potential risks like rectal wall infiltration and associated toxicity should be considered. ^{2 3 5 6 7}

Is the treatment called Rectal Spacers for Prostate Cancer a promising treatment?

Yes, rectal spacers are a promising treatment for prostate cancer. They help protect the rectum by creating a space between it and the prostate during radiation therapy. This reduces the amount of radiation the rectum receives, which can lower the risk of side effects and improve the patient's quality of life. ^{1 2 3 4 8}

Research Team

Eligibility Criteria

This trial is for up to 150 people with localized prostate cancer who are planning to have radiation therapy. Participants must be eligible for rectal spacer placement, but specific inclusion and exclusion criteria details are not provided.

Inclusion Criteria

Ability to understand and the willingness to sign a written informed consent form

My prostate cancer is in the early stages and not aggressive.

I am 18 or older with prostate cancer.

Exclusion Criteria

My cancer has spread to other parts of my body.

I am being treated with steroids for my inflammatory bowel disease.

I have inflammation of the prostate.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

Spacer Placement

Participants undergo placement of the rectal spacer prior to radiation therapy

Treatment Planning Simulation

Participants undergo treatment planning simulation to prepare for radiation therapy

Radiation Treatment

Participants receive radiation therapy for the treatment of localized prostate cancer

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

1, 3, and 6-month follow-up visits

Treatment Details

Interventions

• BioProtect Balloon Implant™ System (Brachytherapy)

Trial Overview The study is testing the BioProtect Balloon Implant™ System as a rectal spacer in patients receiving radiation treatment for prostate cancer. It aims to evaluate its safety and effectiveness through several visits including screening, implantation, simulation, post-treatment, and follow-ups at 1, 3, and 6 months.

Participant Groups

Group I: BioProtect Balloon Implant System Experimental Treatment 1 Intervention

The Bio Protect Balloon Implant System (BioProtectLtd.,TzurYigal,Israel) is an Food and Drug Administration approved rectal spacer that consists of a solid biodegradable balloon-shaped material composed of poly L-Lactide-co-caprolactone

Who Is Running the Clinical Trial?

Advanced Radiation Centers of New York

Lead Sponsor

Trials

1

Recruited

150+

Findings from Research

The use of a hydrogel spacer during prostate cancer radiotherapy showed no significant increase in bowel bother symptoms compared to conventional treatment methods, indicating its safety in preserving bowel quality of life during treatment.

While all groups experienced moderate changes in bowel quality of life during radiotherapy, the hydrogel spacer group showed the least long-term impact on bowel bother scores, suggesting potential benefits in symptom management a few weeks post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of life after intensity-modulated radiotherapy for prostate cancer with a hydrogel spacer. Matched-pair analysis. Pinkawa, M., Piroth, MD., Holy, R., et al.[2021]

In a study of 149 patients, hydrogel spacers were effective in significantly reducing rectal radiation dose during prostate cancer treatment, even when the spacers were asymmetrically placed, with 98.7% of patients achieving significant dose reduction.

Rectal wall infiltration of the hydrogel spacer occurred in only 6% of patients, and this infiltration did not correlate with any adverse events or complications, indicating a favorable safety profile for the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hydrogel spacer distribution within the perirectal space in patients undergoing radiotherapy for prostate cancer: Impact of spacer symmetry on rectal dose reduction and the clinical consequences of hydrogel infiltration into the rectal wall. Fischer-Valuck, BW., Chundury, A., Gay, H., et al.[2018]

The absorbable hydrogel perirectal spacer (SpaceOAR®) was successfully implanted in 222 men undergoing prostate cancer radiotherapy, with a 99.3% success rate and minimal mild transient side effects, indicating it is a safe and tolerable procedure.

The spacer significantly reduced the rectal radiation dose in 97.3% of patients and led to lower rates of late rectal toxicity and improved bowel quality of life compared to the control group, suggesting it enhances the safety and efficacy of prostate radiotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hydrogel Spacer Application Technique, Patient Tolerance and Impact on Prostate Intensity Modulated Radiation Therapy: Results from a Prospective, Multicenter, Pivotal Randomized Controlled Trial. Pieczonka, CM., Mariados, N., Sylvester, JE., et al.[2023]

In a study of 160 patients, the hydrogel spacer was successfully placed with a symmetrical distribution in 73.1% of cases, effectively separating the prostate from the rectum by an average of 10.2 mm, which helps reduce radiation exposure to the rectum during therapy.

The procedure had a low incidence of complications, with only 4.3% of patients experiencing minimal rectal wall infiltration and a very small number requiring emergency treatment, indicating that the hydrogel spacer can be safely used in patients undergoing radiation for prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SpaceOAR hydrogel distribution and early complications in patients undergoing radiation therapy for prostate cancer. Yates, AH., Power, JW., Dempsey, PJ., et al.[2023]

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]

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]

A case was reported of a severe rectal ulcer classified as a grade 3 complication following intensity-modulated radiotherapy for prostate cancer, indicating a significant adverse effect of the treatment.

The complication occurred despite the use of the SpaceOAR® hydrogel spacer, which is designed to reduce radiation exposure to the rectum during prostate cancer treatment, highlighting the need for careful monitoring of side effects even with protective measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Case of Rectal Ulcer during Intensity Modulated Radiotherapy for Prostate Cancer Using Hydrogel Spacer. Dinh, TT., Schade, GR., Liao, JJ.[2023]

Hydrogel rectal spacers are beneficial in reducing radiation exposure to the rectum during external beam radiation therapy for prostate cancer, which can help minimize adverse effects.

The review provides a comprehensive framework for the effective use of rectal spacers in patients with unfavorable risk prostate cancer undergoing dose escalated Stereotactic Body Radiation Therapy (SBRT), highlighting best practices and treatment planning considerations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rationale for Utilization of Hydrogel Rectal Spacers in Dose Escalated SBRT for the Treatment of Unfavorable Risk Prostate Cancer. Repka, MC., Creswell, M., Lischalk, JW., et al.[2022]

References

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

Quality of life after intensity-modulated radiotherapy for prostate cancer with a hydrogel spacer. Matched-pair analysis. [2021]

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

Hydrogel spacer distribution within the perirectal space in patients undergoing radiotherapy for prostate cancer: Impact of spacer symmetry on rectal dose reduction and the clinical consequences of hydrogel infiltration into the rectal wall. [2018]

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

Hydrogel Spacer Application Technique, Patient Tolerance and Impact on Prostate Intensity Modulated Radiation Therapy: Results from a Prospective, Multicenter, Pivotal Randomized Controlled Trial. [2023]

4. England pubmed.ncbi.nlm.nih.gov

SpaceOAR hydrogel distribution and early complications in patients undergoing radiation therapy for prostate cancer. [2023]

5. Australia pubmed.ncbi.nlm.nih.gov

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

A Case of Rectal Ulcer during Intensity Modulated Radiotherapy for Prostate Cancer Using Hydrogel Spacer. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Rationale for Utilization of Hydrogel Rectal Spacers in Dose Escalated SBRT for the Treatment of Unfavorable Risk Prostate Cancer. [2022]