Prostate CancerFIRST STARNCT05597852
Using Rectal Hydrogel Spacer for Salvage SABR in Prostate Cancer
A study testing SpaceOAR in people with Prostate Cancer, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- SpaceOAR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 30 Nov 2021to 30 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically and radiologically confirmed locally recurrent prostate adenocarcinoma
- Willing to give informed consent to participate in this clinical trial
- Able and willing to complete EPIC and EQ-5D questionnaires
Who cannot join
- Contraindication to prostate MRI
- Anticoagulation medication (if unsafe to discontinue)
- Diagnosis of bleeding diathesis
- Poor baseline urinary function defined as International Prostate Symptom Score (IPSS) >20
- Evidence of castrate resistance (defined as PSA > 3 ng/ml while testosterone is < 0.7nmol/l). Patients could have been on combined androgen blockade but are excluded if this was started due to PSA progression.
- Definitive extrapelvic nodal or distant metastatic disease on staging investigations.
- Prior ultra-hypofractionated radiotherapy ( SBRT of 5Gy/fraction or higher)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Sunnybrook Odette Cancer Centre
Toronto, Ontario, M4N 3M5
Amandeep Taggar, MD, 416 480 6165
Andrew Loblaw, MD
About this study
Official title: Feasibility of Integrating Rectal Hydrogel Spacer for Salvage Treatment Using Stereotactic Ablative Body Radiotherapy for Locally Recurrent Prostate Cancer
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.
Read the detailed description
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.
- Conditions
- Prostate Cancer
- Being tested
- SpaceOAR
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpaceOARDevice
SpaceOAR hydrogel spacer between the prostate and rectum, in an effort to decrease toxicity and improve patient's bowel quality of life.
| Study group | Role | What they receive |
|---|---|---|
| Study Arm | Experimental | 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. Receives: Device: SpaceOAR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of SpaceOAR
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;
Measured: 5 year
Secondary outcomes (6)
Acute and late cumulative incidence of toxicities
Acute and Late Cumulative incidence Using the CTCAE V5.0 for toxicities. Change of toxicity measured from Baseline
Measured: 5 years
Quality of Life using EPIC
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.
Measured: 5 years
Biochemical disease-free survival
PSA levels will checked for biochemical disease-free survival
Measured: 5 years
Use of salvage ADT
Up to eighteen months of luteinizing-hormone releasing hormone agonists or antagonists can be used according to physician discretion.
Measured: 18 Months
Health utilities
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.
Measured: 5 years
Quality of Life using IPSS
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2022
- Study start30 Nov 2021
- Primary completion30 Nov 2022 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients with local recurrence of prostate cancer with previous irradiation will have a hydrogel spacer, SpaceOAR™ inserted.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amandeep Taggar, MD, Principal investigator, Sunnybrook
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05597852
- Sponsor's protocol ID
- FIRST STAR
- Acronym
- FIRST STAR
- Status last verified
- Oct 2022
- First submitted
- 17 Oct 2022
- Last updated
- 28 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Integrating Rectal Hydrogel Spacer for Salvage Treatment Using Stereotactic Ablative Body Radiotherapy for Locally Recurrent Prostate Cancer
- ClinicalTrials.gov ID
- NCT05597852
- Acronym / sponsor ID
- FIRST STAR / FIRST STAR
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 30 Nov 2021 (actual)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 28 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients with local recurrence of prostate cancer with previous irradiation will have a hydrogel spacer, SpaceOAR™ inserted.
| Arm | Type | Receives |
|---|---|---|
| Study Arm | Experimental | Device: SpaceOARAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Histologically and radiologically confirmed locally recurrent prostate adenocarcinoma
- Willing to give informed consent to participate in this clinical trial
- Able and willing to complete EPIC and EQ-5D questionnaires
Key exclusion criteria (7 listed)
- Contraindication to prostate MRI
- Anticoagulation medication (if unsafe to discontinue)
- Diagnosis of bleeding diathesis
- Poor baseline urinary function defined as International Prostate Symptom Score (IPSS) >20
- Evidence of castrate resistance (defined as PSA > 3 ng/ml while testosterone is < 0.7nmol/l). Patients could have been on combined androgen blockade but are excluded if this was started due to PSA progression.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SpaceOARSpaceOAR hydrogel spacer between the prostate and rectum, in an effort to decrease toxicity and improve patient's bowel quality of life. | Device | Study Arm |
Primary outcome
Feasibility of SpaceOAR
Time frame: 5 year
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;
6 secondary outcomes
Acute and late cumulative incidence of toxicities
Time frame: 5 years
Quality of Life using EPIC
Time frame: 5 years
Biochemical disease-free survival
Time frame: 5 years
Use of salvage ADT
Time frame: 18 Months
Health utilities
Time frame: 5 years
Quality of Life using IPSS
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amandeep Taggar, MD principal investigator
Sunnybrook
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SpaceOAR in people with Prostate Cancer, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amandeep Taggar, MD (416 480 6165, aman.taggar@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of SpaceOAR (time frame: 5 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2022.