Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Urogenital Neoplasms

Genital Neoplasms, Male

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Single dose of DuraSeal product with DuraSeal components diluted 1:1 in sterile saline injected between rectum and prostate

Single dose of DuraSeal product injected between rectum and prostate

Diluted spacer

Non-diluted spacer

Markku Vaarala, MD,PhD

Merja Korpela, MD

Vesa-Pekka Heikkilä, PhL

The purpose of this study is to evaluate the usefulness of diluted and non-diluted DuraSeal product as a spacer between prostate and rectum in prostate cancer low-dose brachytherapy.

Radiation therapy for prostate cancer leads to inappropriate radiation dose to the rectum wall leading rectum adverse effects in long term for some patients. A resorbable spaces between prostate and rectum could decrease the incidence of these side effect. In this trial, men with prostate cancer with intention to curative treatment by low-dose brachytherapy will be recruited. The subjects will be randomized to receive either diluted or non-diluted DuraSeal product as a spacer between prostate and rectum. Diluted or non-diluted DuraSeal will be applied between rectum and prostate at the end of the brachytherapy seed implantation procedure. After the implantation of the brachytherapy seeds, a needle is placed between rectum and prostate through perineal skin under transrectal ultrasound guidance. The proper position of the needle is confirmed by the injection of 10-15 ml sterile saline solution. After that, DuraSeal components are diluted in 1:1 with sterile saline and 6-10 ml of this diluted product will be injected using DuraSeal applicator. If the subject is randomized to receive non-diluted DuraSeal, the procedure will be identical with the exception the DuraSeal components will not be diluted. The resolution of the spacer will be followed by repeated plain computer tomography (CT) of pelvis performed a day before operation, a day after the operation, and 4, 8 and 12 weeks after the operation. In addition, magnetic resonance imaging of pelvis performed 12 weeks after the operation. The space created between prostate and rectum will be documented by plain CT and magnetic resonance imaging. Rectum radiation dose will be calculated based on these scans. Time to DuraSeal resolution will be evaluated from the scans. Possible side effects will be collected by subject interviews during follow-up visits at 4, 8 and 12 weeks after the operation.

Protection of Rectum From High Radiation Doses Using a Spacer

Protection of Rectum From High Radiation Doses During Prostate Cancer Low-dose Brachytherapy Using Diluted or Non-diluted DuraSeal as a Spacer

Time to spacer resolution will be measured based on the distance between rectum wall and prostate on CT scans before operation and on defined time frame. In addition, magnetic resonance imaging of pelvis will be performed 12 weeks after the operation in order to confirm the extent of spacer.

Possible side effects will be collected by subject interview and physical examination on specified time frame.

Rectum dose will be calculated based on CT scans after brachytherapy.

Oulu University Hospital

University of Oulu

Associate Chief Urologist

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

All Drugs and Chemicals

Hyaluronic Acid

Moderate hypofractionated radiotherapy of 62Gy in 20 fraction of 3.1Gy.

Moderate hypofractionated radiotherapy

Stereotactic radiotherapy of 37.5Gy in 5 fraction of 7.5Gy.

Stereotactic radiotherapy

The present randomized, open, multicentric Phase II trial, in parallel groups with two arms of treatment, compares the treatment A, moderate hypofractionated radiotherapy of 62Gy, to treatment B, stereotactic irradiation of 37.5 Gy with hyaluronic acid injection in the space between the prostate and the rectum to preserve the rectal-wall from high doses of irradiation. The study aims to assess the rates of late urinary toxicities of grade ≥ 2 induced by a moderate hypofractionated radiotherapy (62Gy in 20 fractions of 3.1Gy) and by a stereotactic radiotherapy (37.5Gy in 5 fractions of 7.5Gy), and the rectal toxicities after an injection of hyaluronic acid between the rectal wall and the prostate.

Ninety-six patients and 9 centers are included in the protocol.

Hypofractionated Radiotherapy Versus Stereotactic Irradiation With Hyaluronic Acid

Moderate Hypofractionated Radiotherapy (62 Gy in 20 Fractions of 3.1 Gy) Versus Stereotactic Radiotherapy (37.5 Gy in 5 Fractions of 7.5 Gy) With Hyaluronic Acid Injection Between the Prostate and the Rectum for Prostate Cancer of Low- to Intermediate Risk; RPAH2

Late urinary toxicities of grade ≥ 2 assessed using the Common Toxicity Criteria for Adverse Effects ( CTCAE) v 4.0 classification from 3 months to 3 years.

Survival rates without biological relapse (increase of the PSA (prostate-specific antigen) beyond nadir + 2 ng/ml, using Phoenix definition).

all toxicities will be listed using Common Toxicity Criteria for Adverse Effects (CTCAE) v4.0.

evaluation and comparison of the sexual preservation rates in both arms using International Index of Erectile Function (IIEF).

Late rectal toxicities in both arms, for the evaluation of the hyaluronic acid efficacy to preserve the rectal wall in both approaches, using Common Toxicity Criteria for Adverse Effects (CTCAE) 4.0.

Hospices Civils de Lyon

Central Nervous System Depressants

Anti-Arrhythmia Agents

Channel Blockers

Anesthetics

Lidocaine

Adjuvants, Immunologic

Immunologic Factors

Viscosupplements

Protective Agents

Rectal toxicities after prostate hypofractionated radiotherapy with hyaluronic acid

One injection of 3 to 10 cc of hyaluronic acid (Macrolane VRF 30®, Q-MED) introduced in the perirectal fat between the rectum and the prostate in connection with an ultrasound.

The injection is performed under local anesthesia (with "Lidocaine") and ultrasound guidance, using a 16 gauge needle.

Hyaluronic acid (Macrolane VRF 30®, Q-MED)

The present Phase II study aims to assess the rates of late rectal toxicities of grade ≥ 2 after hypofractionated radiotherapy of prostate cancer of 62 Gy in 20 fractions of 3.1 Gy with an injection of hyaluronic acid (HA) in the space between the rectum and the prostate. Thirty-six patients with a low- to intermediate-risk prostate cancer according to the D'Amico classification are included in the present protocol. The main characteristics of the study are that the patients benefit of a reduction of the treatment duration from 40 to 20 fractions, due to the hypofractionated irradiation, and of an injection of 3 to 10 cc of hyaluronic acid in the perirectal fat between the rectum and the prostate.

Hyaluronic Acid for Hypofractionated Prostate Radiotherapy

Hypofractionated Radiotherapy for Prostate Cancer (62 Gy in 20 Fractions of 3.1 Gy) With Hyaluronic Acid Injection

Late rectal toxicities of grade ≥ 2 assessed using the CTCAE v 4.0 classification from 3 months to 3 years.

Number of patients with acute rectal toxicities of all grades and of grade ≥ 2 (using the CTCAE v 4.0), as a measure of safety and tolerability.

The evaluation of the tolerance of the HA injection, as a measure of safety and tolerability (using the CTCAE v 4.0).

Number of patients with acute and late toxicities (using the CTCAE v 4.0), other than the rectal toxicities, as a measure of safety and tolerability.

Men meeting the study eligibility criteria will be scheduled for fiducial marker placement using a transperineal approach with ultrasound guidance. Following successful fiducial marker placement, subjects will be randomized (2:1) to the treatment group or control group. Subjects randomized to the treatment group will undergo placement of 10 mL of SpaceOAR hydrogel

Men meeting the study eligibility criteria will be scheduled for fiducial marker placement using a transperineal approach with ultrasound guidance. Following successful fiducial marker placement, subjects will be randomized (2:1) to the treatment group or control group. Subjects randomized to the control group will not receive injection of the SpaceOAR hydrogel.

Fiducial marker placement followed by randomization to treatment group, i.e., 10mL SpaceOAR hydrogel injection, or control group, i.e., no injection of SpaceOAR hydrogel.

SpaceOAR System

Evaluate the safety of the SpaceOAR System when the hydrogel is injected between the rectum and prostate in men undergoing radiation therapy (IG-IMRT)

The purpose of this study is to evaluate the safety of the SpaceOAR System when the hydrogel is injected between the rectum and prostate in men undergoing radiation therapy (IG-IMRT) and to evaluate whether use of the SpaceOAR hydrogel results in a reduction of radiation exposure to the anterior rectum.

SpaceOAR System Pivotal Study

Evaluation of SpaceOAR™ System When Used to Create Space Between the Rectum and Prostate in Men Undergoing IG-IMRT for Localized Stage T1-T2 Prostate Cancer: A Randomized, Multicenter, Parallel Arm Controlled Clinical Study

Measurements calculated and documented by the Core Lab. Measurements performed with the Core Lab blinded to subject identification. Results based on the Core Lab computation are considered as primary.

The primary safety endpoint was the occurrence of Grade 1 or greater rectal adverse events or procedure adverse events in the 6 months following the Index Procedure. The numbers reflect the percent of subjects in each arm/group that experienced grade 1 or greater rectal or procedure adverse events post index procedure.

The numbers reflect the percent of subjects in each arm/group that experienced grade 2 or greater rectal or procedure adverse events post index procedure.

Expanded Prostate Cancer Index Composite (EPIC) is a comprehensive survey instrument designed to assesses the disease-specific aspects of prostate cancer and its therapies and comprises four domains. Scores for each domain (urinary, sexual, bowel, hormonal) range from 0-100, with higher scores indicating improved quality of life. Scores are reported as mean change from baseline at each time point.

The numbers reflect the percent of subjects in each arm/group that required at least one medication change to treat rectal or urinary symptoms in the 6 months post index procedure.

An event was classified as a Procedure AE if it occurred during during and immediately after the Index Procedure or was deemed to be associated with the Index Procedure by the Clinical Events Committee (CEC). Per protocol subjects were to begin intensity modulated radiation therapy within 21 days following fiducial marker and/or SpaceOAR placement.

All subjects begin Intensity Modulated Radiation Therapy (IMRT) within 21 days following index procedure (Fiducial Marker Placement with or without SpaceOAR Hydrogel Injection).

Augmenix, Inc.

Boston Scientific Corporation

Subjects randomized to receive SpaceOAR hydrogel.

SpaceOAR

Subjects randomized to not receive SpaceOAR hydrogel.

Control

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Subjects may check more than one category, therefore this is why SpaceOAR subjects = 150/149.

Race (NIH/OMB)

United States

Region of Enrollment

Director, Clinical Operations

Number of Subjects Achieving a Reduction of 25% or Greater in Percent Volume of the Rectum Receiving at Least 70 Gy Measured From CT Scans Acquired Pre and Post SpaceOAR Hydrogel Injection

Intent-to-Treat (ITT) population was defined to be all randomized subjects (SpaceOAR and Control group).

Percentage of Subjects Experiencing Grade 1 or Greater Rectal or Procedure Adverse Events Post Index Procedure

Percentage of Subjects Experiencing Grade 2 or Greater Rectal or Procedure Adverse Events in the 6 Months Following the Index Procedure

Change in Urinary Assessment Composite Score at 3 Months

Change in Urinary Assessment Composite Score at 6 Months

Change in Urinary Assessment Composite Score at 12 Months

Change in Urinary Assessment Composite Score at 15 Months

Change in Sexual Assessment Composite Score at 3 Months

Change in Sexual Assessment Composite Score at 6 Months

Change in Sexual Assessment Composite Score at 12 Months

Change in Sexual Assessment Composite Score at 15 Months

Change in Bowel Habits Assessment Composite Score at 3 Months

Change in Bowel Habits Assessment Composite Score at 6 Months

Change in Bowel Habits Assessment Composite Score at 12 Months

Change in Bowel Habits Assessment Composite Score at 15 Months

Change in Hormonal Assessment Composite Score at 3 Months

Change in Hormonal Assessment Composite Score at 6 Months

Change in Hormonal Assessment Composite Score at 12 Months

Change in Hormonal Assessment Composite Score at 15 Months

Intent-to-Treat (ITT) population was defined to be all randomized subjects (SpaceOAR and Control group). Mean change in score was calculated for the number of subjects providing data at each follow-up visit.

Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Score Following Index Procedure

Percentage of Subjects Requiring at Least One Medication Change for Mitigation of Rectal or Urinary Symptoms or for Procedure-related Events in the 6 Months Following the Index Procedure

SpaceOAR treated subjects experiencing a procedure related AE prior to initiation of radiation therapy.

Number of SpaceOAR Subjects Experiencing a Procedure-Related Adverse Event (AE) Prior to Initiation of Radiation Therapy

Subjects randomized to not receive SpaceOAR hydrogel

Number of Subjects Experiencing a Delay in Radiation Therapy Associated With a Procedure or Device-Related Adverse Event

Subjects meeting the study eligibility criteria will be scheduled for fiducial marker placement using a transperineal approach with ultrasound guidance. Following successful fiducial marker placement, subjects will be randomized (2:1) to the treatment group or control group. Subjects randomized to the treatment group will undergo placement of 10 mL of SpaceOAR hydrogel

SpaceOAR System: Fiducial marker placement followed by randomization to treatment group, i.e., 10mL SpaceOAR hydrogel injection, or control group, i.e., no injection of SpaceOAR hydrogel.

Subjects meeting the study eligibility criteria will be scheduled for fiducial marker placement using a transperineal approach with ultrasound guidance. Following successful fiducial marker placement, subjects will be randomized (2:1) to the treatment group or control group. Subjects randomized to the control group will not receive injection of the SpaceOAR hydrogel.

Overall Study

Males at least 18 years of age, who underwent radiation therapy with a hydrogel spacer in place.

Assessment of rectal dosimetry change from pre-insertion to post-insertion in subjects with prostate cancer who have undergone radiotherapy with a hydrogel spacer.

Observation

Dosimetry efficacy of the hydrogel spacer.

Single arm study for evaluation of dosimetry following use of a commercially available hydrogel spacer implanted in up to 20 males who underwent radiotherapy treatment for prostate cancer. Study utilized pre and post gel insertion CT images to determine endpoints.

Retrospective Evaluation of a Commercially Available Hydrogel Spacer (BP-009)

Clinical Protocol for the Retrospective Evaluation of a Commercially Available Hydrogel Spacer

Assessment of rectal radiation exposure as compared between rectal dose volume histograms calculated for pre and post hydrogel injection

Prostate to rectum spacing as measured post hydrogel insertion based on CT simulation scans done after hydrogel insertion

BioProtect

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.

Males at least 18 years of age, who will be undergoing radiation therapy with a hydrogel spacer in place.

Dosimetry efficacy evaluation of the hydrogel spacer

Single arm study for evaluation of dosimetry following use of a commercially available hydrogel spacer implanted in 20 males undergoing radiotherapy to treat prostate cancer. Study will utilize pre and post gel insertion CT images to determine the endpoints.

Prospective Evaluation of a Commercially Available Hydrogel Spacer

Clinical Protocol for the Prospective Evaluation of a Commercially Available Hydrogel Spacer

Assessment of rectal radiation exposure as compared between rectal dose volume histograms calculated for pre and post Hydrogel Injection

Prostate to rectum spacing measurement for evaluation of the perirectal distance post-hydrogel insertion

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Protection of Rectum From High Radiation Doses Using a Spacer	NCT01918605	Prostatic Neopl... Genital Neoplas... Urogenital Neop... Neoplasms by Si...	Diluted spacer Non-diluted spa...	50 Years - 78 Years	University of Oulu
Hypofractionated Radiotherapy Versus Stereotactic Irradiation With Hyaluronic Acid	NCT02361515	Prostatic Adeno...	Moderate hypofr... Stereotactic ra...	18 Years - 80 Years	Hospices Civils de Lyon
Hyaluronic Acid for Hypofractionated Prostate Radiotherapy	NCT02165020	Prostate Cancer	Hyaluronic acid...	18 Years - 80 Years	Hospices Civils de Lyon
SpaceOAR System Pivotal Study	NCT01538628	Prostate Cancer	SpaceOAR System	18 Years -	Boston Scientific Corporation
Retrospective Evaluation of a Commercially Available Hydrogel Spacer (BP-009)	NCT05423431	Prostate Cancer	Observation	18 Years -	BioProtect
SpaceOAR System Pivotal Study	NCT01538628	Prostate Cancer	SpaceOAR System	18 Years -	Boston Scientific Corporation
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
Prospective Evaluation of a Commercially Available Hydrogel Spacer	NCT05323747	Prostate Cancer	Observation	18 Years -	BioProtect

Spots Global Cancer Trial Database for spacer

Every month we try and update this database with for spacer 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 spacer

Every month we try and update this database with for spacer 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 spacer 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.