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Prostate CancerPhase 2NCT02353832

Stereotactic Ablative Radiotherapy (SABR) for Low Risk Prostate Cancer With Injectable Rectal Spacer

A Phase 2 study testing Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent) in people with Prostate Cancer, run by University of Texas Southwestern Medical Center at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose is to determine if use of rectal spacers are effective at improving protection of rectum from high dose radiation, using rate of rectal ulceration as a surrogate measure of acute effects. Read more about this study

Who is it for?
Ages 18 to 99 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
2 sitesUnited States
Study dates
6 Nov 2014to 5 Jan 2021
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 to 99 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All patients must be willing and capable to provide informed consent to participate in the protocol.
  • Eligible patients must have appropriate staging studies identifying them as AJCC stage T1 (a, b, or c) or T2a or T2b adenocarcinoma of the prostate gland. The patient should not have direct evidence of regional or distant metastases after appropriate staging studies. Histologic confirmation of cancer will be required by biopsy performed within 180 days of registration.
  • The patient's Zubrod performance status must be 0-2.
  • The Gleason score should be less than or equal to 6 or 3+4 if < 50% of a 12 core biopsy was involved.
  • The serum PSA should be less than or equal to 10 ng/ml.
  • Study entry PSA must not be obtained during the following time frames: 10 day period following prostate biopsy; following initiation of ADT; within 30 days after discontinuation of finasteride; or within 90 days after discontinuation of dutasteride.
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  • Age ≥ 18 years.
  • Patients may have used prior hormonal therapy, but it should be limited to no more than 9 months of therapy prior to enrollment.
  • The ultrasound, or CT based volume estimation of the patient's prostate gland should be ≤ 60 grams.

Who cannot join

  • Subjects who have had previous pelvic radiotherapy or have had chemotherapy or surgery for prostate cancer.
  • Subjects who have plans to receive other concomitant or post treatment adjuvant antineoplastic therapy while on this protocol including surgery, cryotherapy, conventionally fractionated radiotherapy, hormonal therapy, or chemotherapy given as part of the treatment of prostate cancer.
  • Subjects who have undergone previous transurethral resection of the prostate (TURP) or cryotherapy to the prostate. Subjects who have significant urinary obstructive symptoms; AUA score must be ≤15 (alpha blockers allowed).
  • Subjects who have a history of significant psychiatric illness.
  • Men of reproductive potential who do not agree that they or their partner will use an effective contraceptive method such as condom/diaphragm and spermacidal foam, intrauterine device (IUD), or prescription birth control pills.
  • Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (e.g., carcinoma in situ of the breast, oral cavity, or cervix are all permissible).
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  • Severe, active co-morbidity, defined as follows:
  • Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months.
  • Transmural myocardial infarction within the last 6 months.
  • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration.
  • Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before registration.
  • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol.
  • Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immuno-compromised patients.
  • Patients with history of inflammatory colitis (including Crohn's Disease and Ulcerative colitis) are not eligible.
  • Subjects with a known allergy to polyethylene glycol hydrogel (spacer material) or contraindication to spacer products (Duraseal or SpaceOAR).
  • Subjects with evidence of extraprostatic extension (T3a) or seminal vesicle involvement (T3b) on clinical evaluation.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

Other trials in United States

About this study

Official title: Phase II Study of Stereotactic Ablative Radiotherapy (SABR) for Low Risk Prostate Cancer With Injectable Rectal Spacer

The purpose is to determine if use of rectal spacers are effective at improving protection of rectum from high dose radiation, using rate of rectal ulceration as a surrogate measure of acute effects. It is also to determine whether it provides sufficient dosimetric benefits to warrant further clinical investigation in future SABR (Stereotactic Ablative Body Radiation) related clinical studies.

Read the detailed description

A phase II study to assess safety and efficacy of the spacer injection process, ability of the spacer to effectively provide the space necessary to reduce acute events in the rectum, and also meet the SABR based rectal constraints, and to monitor stability of this process during SABR. Unlike IMRT, which uses smaller dose/fraction, when using such high dose/fraction, even a few mm of shift in spacer positioning may impact the dose that the rectum receives, and therefore, a rigorous study of stability of material during the SABR treatments will need to be determined. If there is some shift, by doing this study, we may be able to determine the margin of error that will be necessary in considering rectal organ dosimetry, based on the possible shift in positiong that may occur with the spacer over time.

As the SABR therapy is strictly local, we will select for patients with prostate cancer locally confined to the prostate gland. As such, we will select eligibility criteria of low risk patients to minimize risk of extraprostatic spread, seminal vesicle invasion, and nodal spread. Hormonal therapy may also be used to shrink prostates that are massively enlarged as this may also help further reduce length of rectum that will be irradiated. As the primary toxicity will likely be mucosal damage, we will avoid enrolling patients with pre-existing mucosal dysfunction (including those with previous radiation, TURP, very large prostate glands, inflammatory bowel disease) and immunosuppressed individuals based on our phase I experience[13]. In this way, patients will be uniformly selected in a fashion that would identify patients likely to receive benefit from the therapy.

Conditions
Prostate Cancer
Being tested
Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent)
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent)Device

    Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product

Study groups in NCT02353832
Study groupRoleWhat they receive
No ArmOtherStudy did not have Arm(s)
Receives: Device: Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Reduction in Acute Per-prostatic Rectal Ulcer Events Events From 90%+ to <70% (Particularly in the Anterior Rectum)

    The effectiveness of rectal spacer use was measured to determine if they are effective at improving protection of rectum from high dose radiation, using rate of rectal ulceration as a surrogate measure of acute effects

    Measured: Median 9 months within the end of radiation treatment

  2. Effectiveness of Space Creation of >= 7.5 mm in Protecting Rectum From Toxicity

    The effectiveness of rectal spacer use was measured to determine if they are effective at improving protection of rectum from high dose radiation, using rate of rectal ulceration as a surrogate measure of acute effects

    Measured: Median 9 months within the end of radiation treatment

Secondary outcomes (30)

  1. Percentage of Participants With Spacer Related Acute Toxicity

    Assess spacer related acute toxicity. Spacer related toxicity could be related to the procedure itself (bleeding, infection, pain), or secondary effects of spacer (erectile dysfunction, persistent pain and discomfort). Adverse events will be graded by a numerical score according to the defined NCI Common Terminology Criteria for Adverse Events (NCI CTCAE V4.0) and version number 4.0 specified in the protocol. Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life threatening; Grade 4: Life threatening consequences; Grade 5: Death related to the adverse event.

    Measured: 270 days

  2. Determine Spacer's Ability to Change Percent Rectal Circumference (PRC) Receiving 39 Gy

    Determine spacer's ability to change percent rectal circumference (PRC) receiving 39 Gy by at least 50%. This will be determined by using CT planning studies for dosimetric analysis before and after spacer placement.

    Measured: 1 month

  3. Determine Spacer's Ability to Change Percent Rectal Circumference (PRC) Receiving 24 Gy.

    Determine spacer's ability to change percent rectal circumference (PRC) receiving 24 and 39 Gy by at least 50%. This will be determined by using CT planning studies for dosimetric analysis before and after spacer placement.

    Measured: 1 month

  4. Acute (Within 270 Days of Treatment) SABR-related Gastrointestinal (GI) Toxicities

    Acute gastrointestinal (GI) toxicity is defined as grade 1-5 toxicity occurring prior to 270 days from the start of protocol treatment. It is graded based on CTCAE v4.0.

    Measured: 270 days

  5. Acute (Within 270 Days of Treatment) SABR-related Genitourinary (GU) Toxicities

    Acute genitourinary (GU)toxicity is defined as grade 1-5 toxicity occurring prior to 270 days from the start of protocol treatment. It is graded based on CTCAE v4.0.

    Measured: 270 days

  6. Chronic (>270 Days From Treatment) SABR-related Genitourinary (GU) Toxicities

    Delayed genitourinary (GU) toxicity is defined as grade 1-5 toxicity occurring after 270 days from the start of protocol treatment. It is graded based on CTCAE v4.0. Adverse events will be graded by a numerical score according to the defined NCI Common Terminology Criteria for Adverse Events (NCI CTCAE V4.0) and version number 4.0 specified in the protocol. Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life threatening; Grade 4: Life threatening consequences; Grade 5: Death related to the adverse event.

    Measured: From day 271 up to 540 days

  7. Chronic (>270 Days From Treatment) SABR-related Gastrointestinal (GI) Toxicities

    Delayed gastrointestinal (GI) toxicity is defined as grade 1-5 toxicity occurring after 270 days from the start of protocol treatment. It is graded based on CTCAE v4.0. Adverse events will be graded by a numerical score according to the defined NCI Common Terminology Criteria for Adverse Events (NCI CTCAE V4.0) and version number 4.0 specified in the protocol. Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life threatening; Grade 4: Life threatening consequences; Grade 5: Death related to the adverse event.

    Measured: From day 271 up to 540 days

  8. Acute Non-GI (Gastrointestinal) and Non-GU (Genitourinary) Toxicity- Irritative

    Toxicity will be assessed according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0.

    Measured: 270 days

  9. Acute Non-GI (Gastrointestinal) and Non-GU (Genitourinary) Toxicity-Obstructive

    Toxicity will be assessed according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0.

    Measured: 270 days

  10. Acute Non-GI (Gastrointestinal) and Non-GU (Genitourinary) Toxicity-Reproductive.

    Toxicity will be assessed according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0.

    Measured: 270 days

  11. Chronic Non-GI (Gastrointestinal) and Non-GU (Genitourinary) Toxicity-Obstructive.

    Toxicity will be assessed according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0. Adverse events will be graded by a numerical score according to the defined NCI Common Terminology Criteria for Adverse Events (NCI CTCAE V4.0) and version number 4.0 specified in the protocol. Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life threatening; Grade 4: Life threatening consequences; Grade 5: Death related to the adverse event.

    Measured: From day 271 up to 540 days

  12. Chronic Non-GI (Gastrointestinal) and Non-GU (Genitourinary) Toxicity-Reproductive.

    Toxicity will be assessed according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0. Adverse events will be graded by a numerical score according to the defined NCI Common Terminology Criteria for Adverse Events (NCI CTCAE V4.0) and version number 4.0 specified in the protocol. Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life threatening; Grade 4: Life threatening consequences; Grade 5: Death related to the adverse event.

    Measured: From day 271 up to 540 days

  13. Chronic Non-GI (Gastrointestinal) and Non-GU (Genitourinary) Toxicity-Irritative.

    Toxicity will be assessed according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0. Adverse events will be graded by a numerical score according to the defined NCI Common Terminology Criteria for Adverse Events (NCI CTCAE V4.0) and version number 4.0 specified in the protocol. Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life threatening; Grade 4: Life threatening consequences; Grade 5: Death related to the adverse event.

    Measured: From day 271 up to 540 days

  14. Freedom From Biochemical Recurrence

    Biochemical failure RTOG-ASTRO definition (also known as Phoenix definition) - Thus, when the PSA rises by more than 2 ng/ml above the lowest level (nadir) achieved after treatment, biochemical failure has occurred and the date of the failure is recorded at the time the nadir plus 2 ng/ml level is reached

    Measured: 4 year

  15. Overall Survival

    Overall survival as measured by percentage of participants who survived at 5 years. The survival time will be measured from the date of accession to the date of death.

    Measured: 5 year

  16. Disease-specific Survival

    Percentage of patients who did not die from prostate cancer at 5 years.

    Measured: 5 year

  17. Local Relapse

    Percentage of patients without local relapse at 3 years. Local relapse will be measured from the date of study entry to the date of documented local relapse as determined by clinical exam.

    Measured: 3 year

  18. Regional Relapse

    Percentage of patients without regional relapse at 3 years. Regional relapse will be measured from the date of study entry to the date of documented regional nodal recurrence or distant disease relapse.

    Measured: 3 years

  19. Distant Relapse

    Percentage of patients without distant relapse at 3 years. Distant relapse will be measured from the date of study entry to the date of documented regional nodal recurrence or distant disease relapse.

    Measured: 3 years

  20. EPIC (Expanded Prostate Cancer Index Composite) Bowel Function

    Outcomes for bowel function and effect on quality of life. Expanded Prostate Cancer Index Composite (EPIC) bowel function score (range, 0 (worst) -100 (best)). EPIC bowel urgency (percentages are for men reporting more than a small problem). EPIC bowel frequency (percentages are for men reporting more than a small problem). EPIC bowel leakage or fecal incontinence (percentages are for men having fecal incontinence at least once per week). EPIC bloody stools (percentages are for men having bloody stools half the time or more). EPIC bowel, pelvic, or rectal pain (percentages are for men reporting more than a small problem). EPIC bowel habits (percentages are for men reporting more than a small problem).

    Measured: 18 months

  21. EPIC (Expanded Prostate Cancer Index Composite) Bowel Frequency

    Outcomes for bowel function and effect on quality of life. Expanded Prostate Cancer Index Composite (EPIC) bowel function score (range, 0-100). EPIC bowel urgency (percentages are for men reporting more than a small problem). EPIC bowel frequency (percentages are for men reporting more than a small problem). EPIC bowel leakage or fecal incontinence (percentages are for men having fecal incontinence at least once per week). EPIC bloody stools (percentages are for men having bloody stools half the time or more). EPIC bowel, pelvic, or rectal pain (percentages are for men reporting more than a small problem). EPIC bowel habits (percentages are for men reporting more than a small problem).

    Measured: 18 months

  22. EPIC (Expanded Prostate Cancer Index Composite) Bloody Stools

    Outcomes for bowel function and effect on quality of life. Expanded Prostate Cancer Index Composite (EPIC) bowel function score (range, 0-100). EPIC bowel urgency (percentages are for men reporting more than a small problem). EPIC bowel frequency (percentages are for men reporting more than a small problem). EPIC bowel leakage or fecal incontinence (percentages are for men having fecal incontinence at least once per week). EPIC bloody stools (percentages are for men having bloody stools half the time or more). EPIC bowel, pelvic, or rectal pain (percentages are for men reporting more than a small problem). EPIC bowel habits (percentages are for men reporting more than a small problem).

    Measured: 18 months

  23. EPIC (Expanded Prostate Cancer Index Composite) Bowel Habits

    Outcomes for bowel function and effect on quality of life. Expanded Prostate Cancer Index Composite (EPIC) bowel function score (range, 0-100). EPIC bowel urgency (percentages are for men reporting more than a small problem). EPIC bowel frequency (percentages are for men reporting more than a small problem). EPIC bowel leakage or fecal incontinence (percentages are for men having fecal incontinence at least once per week). EPIC bloody stools (percentages are for men having bloody stools half the time or more). EPIC bowel, pelvic, or rectal pain (percentages are for men reporting more than a small problem). EPIC bowel habits (percentages are for men reporting more than a small problem).

    Measured: 18 months

  24. EPIC (Expanded Prostate Cancer Index Composite) Bowel Urgency

    Outcomes for bowel function and effect on quality of life. Expanded Prostate Cancer Index Composite (EPIC) bowel function score (range, 0-100). EPIC bowel urgency (percentages are for men reporting more than a small problem). EPIC bowel frequency (percentages are for men reporting more than a small problem). EPIC bowel leakage or fecal incontinence (percentages are for men having fecal incontinence at least once per week). EPIC bloody stools (percentages are for men having bloody stools half the time or more). EPIC bowel, pelvic, or rectal pain (percentages are for men reporting more than a small problem). EPIC bowel habits (percentages are for men reporting more than a small problem).

    Measured: 18 months

  25. EPIC (Expanded Prostate Cancer Index Composite) Bowel Leakage/Fecal Incontinence

    Outcomes for bowel function and effect on quality of life. Expanded Prostate Cancer Index Composite (EPIC) bowel function score (range, 0-100). EPIC bowel urgency (percentages are for men reporting more than a small problem). EPIC bowel frequency (percentages are for men reporting more than a small problem). EPIC bowel leakage or fecal incontinence (percentages are for men having fecal incontinence at least once per week). EPIC bloody stools (percentages are for men having bloody stools half the time or more). EPIC bowel, pelvic, or rectal pain (percentages are for men reporting more than a small problem). EPIC bowel habits (percentages are for men reporting more than a small problem).

    Measured: 18 months

  26. EPIC (Expanded Prostate Cancer Index Composite) Bowel Pelvic/Rectal Pain

    Outcomes for bowel function and effect on quality of life. Expanded Prostate Cancer Index Composite (EPIC) bowel function score (range, 0-100). EPIC bowel urgency (percentages are for men reporting more than a small problem). EPIC bowel frequency (percentages are for men reporting more than a small problem). EPIC bowel leakage or fecal incontinence (percentages are for men having fecal incontinence at least once per week). EPIC bloody stools (percentages are for men having bloody stools half the time or more). EPIC bowel, pelvic, or rectal pain (percentages are for men reporting more than a small problem). EPIC bowel habits (percentages are for men reporting more than a small problem).

    Measured: 18 months

  27. EPIC (Expanded Prostate Cancer Index Composite) Urinary Function

    Outcomes for urinary function and effect on quality of life. Expanded Prostate Cancer Index Composite (EPIC) urinary function score (range, 0 (worst)-100 (best)). EPIC urinary irritation or obstruction (range, 0-100).EPIC urinary incontinence (range, 0-100).

    Measured: 18 months

  28. EPIC (Expanded Prostate Cancer Index Composite) Urinary Irritative/Obstructive

    Outcomes for urinary function and effect on quality of life. Expanded Prostate Cancer Index Composite (EPIC) urinary function score (range, 0-100). EPIC urinary irritation or obstruction (range, 0 (worst)-100 (best)).EPIC urinary incontinence (range, 0-100).

    Measured: 18 months

  29. EPIC (Expanded Prostate Cancer Index Composite) Urinary Incontinence

    Outcomes for urinary function and effect on quality of life. Expanded Prostate Cancer Index Composite (EPIC) urinary function score (range, 0-100). EPIC urinary irritation or obstruction (range, 0-100).EPIC urinary incontinence (range, 0 (worst)-100 (best)).

    Measured: 18 months

  30. AUA (American Urological Association) Quality of Life Questionnaire

    AUA Questionnaire is used to measure urinary symptoms. AUA uses a 7-item self-report measure used to assess urinary urgency, frequency, and voiding symptoms. SYMPTOM SCORE: 0-7 (Mild) 8-19 (Moderate) 20-35 (Severe)

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2015 (estimated)
  2. Study start6 Nov 2014
  3. Primary completion29 Jan 2018
  4. Study completion5 Jan 2021

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02353832
Sponsor's protocol ID
STU 092013-013
Status last verified
Mar 2022
First submitted
16 Jan 2015
Last updated
25 Mar 2022
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent) in people with Prostate Cancer, run by University of Texas Southwestern Medical Center at 2 sites in United States.

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 9 inclusion and 16 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: finished, as of the sponsor's last update on 25 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Reduction in Acute Per-prostatic Rectal Ulcer Events Events From 90%+ to <70% (Particularly in the Anterior Rectum) (time frame: Median 9 months within the end of radiation treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02353832.

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 25 Mar 2022.

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