Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Patients undergo hydrogel rectal spacer placement on day 1. Within 2 weeks (+/-1 week) after Rectal Spacer placement, patients will be scheduled for CT simulation for external beam treatment planning. Patients will begin the SBRT of 24Gy in 5 fractions within 2 weeks (+/-1 week) from the simulation date. Within 4 weeks (+/-1 week) of last day of SBRT, patients undergo brachytherapy. Patient will return for post-implant CT-based dosimetry analysis 4 weeks (+/- 1 week) post brachytherapy,

Medical Device Usage and Evaluation

CT simulation of radiation treatment planning 2-7 days after hydrogel placement

CT simulation

SBRT in 5 fractions over 1 week, 7 days after CT simulation

Stereotactic body radiation therapy

Brachytherapy

Post-implant dosimetry scan

Richard Stock

This phase II trial studies the effect of rectal spacer hydrogel before radiation therapy in reducing radiation dose to the rectum in patients with prostate cancer. Rectal spacer hydrogen is a soft gel material used to create a space between the rectum and prostate during radiation treatment. The rectal spacer gel is made up of 90% water and 10% polyethylene glycol and is injected as a liquid through a needle inserted between the rectum and prostate. It stays in place for about 3 months and is naturally absorbed into the body and removed through urine in about 6 months. By pushing the prostate further from the rectum with the hydrogel, it may help spare the rectum from receiving radiation during standard of care stereotactic body radiation therapy and brachytherapy treatment.

The purpose of this research study is to observe the effects of using an FDA-approved rectal spacer device known as the SpaceOAR Hydrogel, which is a soft gel material used to create a space between the rectum and prostate during radiation treatment. The rectal spacer gel is made up of 90% water and 10% polyethylene glycol and is injected as a liquid through a needle inserted between the rectum and prostate. It will stay in place for about 3 months and is naturally absorbed into the body and removed through urine in about 6 months. By pushing the prostate further from the rectum with the hydrogel, it will help spare the rectum from receiving radiation during the standard of care stereotactic body radiation treatment participant will be receiving, along with the brachytherapy treatment. The hydrogel rectal spacer has been shown to be very safe and effective at reducing radiation dose to the rectum during external radiation treatments, but has not been well-studied when using a combination of Stereotactic Body Radiation Therapy (SBRT) and brachytherapy. The goal of this research is to determine how effective the SpaceOAR hydrogel rectal spacer is at decreasing radiation side effects that can occur in the rectum, which can include discomfort or bleeding. The researchers also want to see how the use of this device affects the doctor's ability to perform the brachytherapy implant safely and effectively.

Rectal Spacer Hydrogel Before Radiation Therapy in Reducing Radiation Dose to the Rectum in Patients With Prostate Cancer

A Non-Randomized Phase II Study of the Reduction in Rectal V100 With the Use of Rectal Spacer Hydrogel in the Management of Intermediate Risk Prostate Cancer Treated With Combined Modality Radiation Therapy

Sharing data is not planned unless specifically requested by another institution.

Volume of the rectum receiving at least 100% of the prescribed dose (V100rectum) \< 0.75 cc rate will be estimated as the proportion of patients that achieve V100rectum \< 0.75 cc at the post-implant dosimetry computed tomography scan 1 month following brachytherapy along with a corresponding two-sided 90% confidence interval using the methods and software introduced by Koyama and Chen which accounts for the group sequential nature of the design

Radiation dose covering 90% of the prostate (D90prostate)

Volume of the prostate receiving at least 150% of the prescribed dose (V150prostate)

Degree of anatomic distortions present while using the brachytherapy template assessed by the physician. Will be summarized as N (%) of patients where varying levels of anatomic distortion was present: No Pubic Arch interference, =\< 5 mm interference and \> 5mm interference.

Degree of ultrasound distortion present Assessed by the physician. Will be summarized as N (%) of patients where varying levels of radiographic distortion was present: No Distortion, Mild Distortion, and Severe Distortion.

The IPSS endpoint is based on a questionnaire made up of eight items, seven of which measure symptom severity and one which assesses quality of life. The symptom severity items include: feeling of incomplete emptying, frequency, intermittency, urgency, weak stream, straining and nocturia, each of which is rated from 0 (''not at all'') to 5 (''almost always''). The IPSS total score ranges from 0-35, with a higher score representing greater severity of symptoms, which can be further categorized into mild (0-7), moderate (8-19) and severe (20-35) symptom severity.

The SHIM endpoint is based on a questionnaire made up of five questions each of which is rated from 1 (''very low'') to 5 (''very high''). The SHIM total score (calculated by summing the individual rating for each question) ranges from 5-25, with a lower score representing greater severity of symptoms which can be further categorized into severe erectile dysfunction (ED) (5-7), moderate ED (8-11), mild to moderate ED (12-16), mild ED (17-21) and no ED (22-25).

The EPIC endpoint is based on a questionnaire made up of 50 questions assessing the disease specific aspects of prostate cancer and its therapies and comprises four summary domains (Urinary, Bowel, Sexual and Hormonal). Factor analysis supports dividing the Urinary Domain Summary Score into two distinct Incontinence and Irritative/Obstructive subscales (Subscales scored from 0-100). In addition, each Domain Summary Score has measurable Function Subscale and Bother Subscale components. Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better health related quality of life.

Icahn School of Medicine at Mount Sinai

Professor, Radiation Oncology

Symptoms and General Pathology

Recurrence

All patients with local recurrence of prostate cancer post irradiation will undergo placement of a hydrogel spacer between the prostate and rectum, in an effort to decrease toxicity and improve patient's bowel quality of life prior to SABR.

SpaceOAR hydrogel spacer between the prostate and rectum, in an effort to decrease toxicity and improve patient's bowel quality of life.

SpaceOAR

Amandeep Taggar, MD

Andrea DeAbreu

Andrew Loblaw, MD

Gerard Morton, MD

Patrick Cheung, MD

Danny Vesprini, MD

Stanley Liu, MD

William Chu, MD

Hans Chung, MD

Melanie Davidson, PhD

Renee Korol, PhD

Moti Paudel, PhD

There are several single institutional series that have reported their experience with salvage radiotherapy options that include EBRT, LDR and HDR brachytherapy. Gastrointestinal (GI) toxicity with salvage radiotherapy range between14-58%, respectively for patients undergoing re-irradiation. There is a concern for an increased risk of fistula development in these patients who receive second course of radiation. Hypofractionation using SABR has been utilized in the re-irradiation setting for prostate cancer with good tumor control and toxicity outcomes. In order to decrease the rectal toxicity, dose to the rectum should be kept as low as possible. Several techniques can be used to achieve this: tighter dosimetric dose painting, better patient or organ immobilization or use of a biodegradable gel. The Investigators ropose a phase I study to assess placement of a hydrogel spacer between the prostate and rectum, in an effort to decrease toxicity and improve patient's bowel quality of life.

Primary treatment of prostate cancer includes surgery or radiotherapy. Although significant improvements have been made in patient selection and treatment planning, local recurrence remains a common problem.

In the case of local recurrence after radiation, salvage options may include prostatectomy, salvage external beam radiotherapy (EBRT) or brachytherapy with low-dose (LDR) or high-dose rate (HDR) implantation, cryotherapy and high intensity focused ultrasound.

There are several single institutional series that have reported their experience with salvage radiotherapy options that include EBRT, LDR and HDR brachytherapy (2-7). Rates of grade 2 or higher genitourinary (GU) and gastrointestinal (GI) toxicity with salvage radiotherapy range between 36-50% and 14-58%, respectively for patients undergoing re-irradiation. GI Toxicity, however, is dependent on total rectal dose. This is especially important among patients who are being considered for re-irradiation. There is a concern for an increased risk of fistula development in these patients who receive second course of radiation although with salvage brachytherapy that risk was only 2% and seen only in patients who had a surgical intervention after salvage brachytherapy.

Hypofractionated regimens have become increasingly common in treatment of prostate cancer, especially with advancement of immobilization and imaging techniques that allow smaller margins and daily verification. Hypofractionation using SABR (Stereotatic Ablative Body Therapy) has been utilized in the re-irradiation setting for prostate cancer with good tumor control and toxicity outcomes. In order to decrease the rectal toxicity, dose to the rectum should be kept as low as possible. Several techniques can be used to achieve this: tighter dosimetric objectives, dose painting, better patient or organ immobilization or use of a biodegradable gel. The latter has been used to increase the distance between the prostate and the rectum for patients who are undergoing prostate radiotherapy. Placement of a hydrogel spacer between the prostate and the rectum has been proven in a randomized controlled trial to reduce rectal dose resulting in decreased acute and long-term rectal toxicity and improvement in bowel-related quality of life. SpaceOAR is an FDA and Health Canada approved, commercially available rectal spacer that, when placed between the prostate and the rectum, has demonstrated to greatly reduce rectal dose and toxicity for patients undergoing external beam radiation and LDR brachytherapy.

Patients with local recurrence of prostate cancer with previous irradiation will have a hydrogel spacer, SpaceOAR™ inserted.

Using Rectal Hydrogel Spacer for Salvage SABR in Prostate Cancer

Feasibility of Integrating Rectal Hydrogel Spacer for Salvage Treatment Using Stereotactic Ablative Body Radiotherapy for Locally Recurrent Prostate Cancer

To assess the feasibility, defined as successful placement in 70% of patients, of placing a hydrogel spacer, SpaceOAR™ in patients with biopsy confirmed locally recurrent prostate cancer, undergoing re-irradiation with hypofractionated external beam radiotherapy;

Acute and Late Cumulative incidence Using the CTCAE V5.0 for toxicities. Change of toxicity measured from Baseline

Acute and late quality of life using Expanded Prostate Index Composite (EPIC) Each question is scored from 1-5, 1 being the better outcome and 5 being the worst outcome.

PSA levels will checked for biochemical disease-free survival

Up to eighteen months of luteinizing-hormone releasing hormone agonists or antagonists can be used according to physician discretion.

Health utilities using the EuroQol-5D (EQ-5D) Each question is scored from 1-5, 1 being the better outcome and 5 being the worst outcome.

Acute and late quality of life using International Prostate Symptom Score (IPSS) Each question is scored from 1-5, 1 being the better outcome and 5 being the worst outcome.

Sunnybrook Health Sciences Centre

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

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

The SpaceOAR Vue System is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space it is the intent of the SpaceOAR Vue System to reduce the radiation dose delivered to the anterior rectum.

The SpaceOAR Vue System is composed of biodegradable material, maintains space for the entire course of prostate radiotherapy treatment and is completely absorbed by the patient's body over time.

SpaceOAR Vue System

Blake Hedstrom

Gwen LeTourneau

John Sylvester, MD

Alexander Engelman, MD

Glen Gejerman, MD

Adam Olson, MD

Jarad Martin, MBChB, PhD

Tanya Holt, MBBS FRANZCR

Jeremy Croker, MD

Pierre Blanchard, MD, PhD

Michael Pinkawa, Dr. Med.

Clemens Albrecht, Dr. med.

Paul Kelly, MB BCh BAO

Nicola Simoni, MD

Filippo Alongi, MD

Alfonso Gomez Iturriaga, MD, PhD

Felipe Couñago, MD, PhD

Asunción Hervás Morón, MBChB, PhD

Jens Lustenberger, MD

Mohamed Shelan, MD

Christos Mikropoulos, MD MSc MRCP

Nachi Palaniappan, MD

Suneil Jain, MB, BCh, PhD

Amit Bahl, MBBS, MD

Vincent Khoo, MD

Jenny Nobes, MBBS, FRCR

Peter Sankey, MB, MRCP

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.

Effectiveness of the SpaceOAR Vue System in Subjects With Prostate Cancer Being Treated With Stereotactic Body Radiotherapy

Proportion of subjects experiencing late GI toxicity after SBRT treatment with or without placement of the SpaceOAR Vue System hydrogel. Late GI toxicity is defined as the occurrence of a Grade 2 or greater GI adverse event (NCI CTCAE v4) between 3- and 24-months post-SBRT initiation

Proportion of subjects experiencing a decrease in EPIC-26 bowel score greater than or equal to the minimal important difference (MID) in EPIC-26 bowel score from baseline to 24 months post-SBRT initiation.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Rectal Spacer Hydrogel Before Radiation Therapy in Reducing Radiation Dose to the Rectum in Patients With Prostate Cancer	NCT05224869	Prostate Cancer	Medical Device ... CT simulation Stereotactic bo... Brachytherapy Post-implant do...	18 Years -	Icahn School of Medicine at Mount Sinai
Using Rectal Hydrogel Spacer for Salvage SABR in Prostate Cancer	NCT05597852	Prostate Cancer	SpaceOAR	18 Years -	Sunnybrook Health Sciences Centre
Effectiveness of the SpaceOAR Vue System in Subjects With Prostate Cancer Being Treated With Stereotactic Body Radiotherapy	NCT04905069	Prostate Cancer	SpaceOAR Vue Sy...	18 Years -	Boston Scientific Corporation

Spots Global Cancer Trial Database for spaceoar

Every month we try and update this database with for spaceoar cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for spaceoar

Every month we try and update this database with for spaceoar cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for spaceoar cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.