Prostate CancerNCT02911922
Randomized Trial of Image -Guided Stereotactic Radiation Therapy (IG-SRT) in Prostate Cancer
A study testing Endorectal Balloon, Rectal Spacer and Radiation therapy in people with Prostate Cancer, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
Patients with low-risk or favorable intermediate-risk prostate cancer as defined by 1.2016 NCCN criteria will be eligible to participate on this study. Read more about this study
- Who is it for?
- Ages 19 to 99 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Endorectal Balloon, Rectal Spacer and Radiation therapy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to 17 Apr 2018
- Phase
- Interventional
- 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 19 to 99 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy-proven diagnosis of prostate adenocarcinoma, diagnosed within 1 year of randomization
- Either NCCN-defined low-risk disease (T1c-T2a, Gleason score 3+3=6, PSA <10), intermediate-risk disease (Gleason score 3+4=7, 4+3=7, T2b-c and/or PSA 10-20; ) or high-risk disease due to Gleason score 8-10 and/or PSA >20 ng/ml, but not due to T3-T4 disease on physical exam.
Who cannot join
- History of prior pelvic radiation (external beam or brachytherapy)
- Prior or concurrent lymphomatous/hematogenous malignancy, or history of prior/concurrent invasive malignancy during the past 5 years
- Very high risk prostate cancer (T3b-T4 on clinical exam, Primary Gleason pattern 5, or >4 cores with Gleason score 8-10)
- History of prior chemotherapy for prostate cancer
- History of irritable bowel disease
- Evidence of lymph node involvement
- AUA score >15
- Prostate size > 90 cc
Trial locations and contacts
1 site in 1 country.
About this study
Patients with low-risk or favorable intermediate-risk prostate cancer as defined by 1.2016 NCCN criteria will be eligible to participate on this study.
Read the detailed description
This is a randomized, two arm study for patients with low-risk or favorable intermediate-risk prostate cancer as defined by 1.2016 NCCN criteria.
Patients will be randomized to either rectal spacer placement or endorectal balloon placement, daily prior to each radiation treatment.
- Endorectal balloon (ERB): Immobilization device manually placed into the rectum prior to radiation treatment planning CT and daily treatment delivery, to immobilize the prostate and reduce prostate motion.
- Rectal spacer (RS): Biodegradable gel that is transperineally injected between the rectum and prostate under transrectal ultrasound guidance, to increase physical distance and thereby reduce radiation dose to the anterior rectal wall. The spacer begins to biodegrade in 2-3 months, and is fully absorbed within 6 months.
This study plans to enroll a total of 40 patients with an accrual period of 4 years.
- Conditions
- Prostate Cancer
- Being tested
- Endorectal Balloon, Rectal Spacer, Radiation therapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endorectal BalloonDevice
Endorectal balloon (ERB): Immobilization device manually placed into the rectum prior to radiation treatment planning CT and daily treatment delivery, to immobilize the prostate and reduce prostate motion.
Patients on each arm will receive 5 fractions of radiation, 7.25Gy per fraction, delivered 2-3 times a week (every other day excluding weekends), to total dose of 36.25 Gy. The total duration of treatment will be no shorter than 10 days.
Rectal SpacerDevice
Rectal spacer (RS): Biodegradable gel that is transperineally injected between the rectum and prostate under transrectal ultrasound guidance, to increase physical distance and thereby reduce radiation dose to the anterior rectal wall. The spacer begins to biodegrade in 2-3 months, and is fully absorbed within 6 months.
Patients on each arm will receive 5 fractions of radiation, 7.25Gy per fraction, delivered 2-3 times a week (every other day excluding weekends), to total dose of 36.25 Gy. The total duration of treatment will be no shorter than 10 days.
Radiation therapyRadiation
Patients on each arm will receive 5 fractions of radiation, 7.25Gy per fraction, delivered 2-3 times a week (every other day excluding weekends), to total dose of 36.25 Gy. The total duration of treatment will be no shorter than 10 days.
| Study group | Role | What they receive |
|---|---|---|
| Endorectal balloon - Radiation therapy | Experimental | Group 1 : Endorectal balloon (ERB): Immobilization device manually placed into the rectum prior to radiation treatment planning CT and daily treatment delivery, to immobilize the prostate and reduce prostate motion.
Patients on each arm will receive 5 fractions of radiation, 7.25Gy per fraction, delivered 2-3 times a week (every other day excluding weekends), to total dose of 36.25 Gy. The total duration of treatment will be no shorter than 10 days. Receives: Device: Endorectal Balloon; Radiation: Radiation therapy |
| Rectal spacer - Radiation therapy | Experimental | Group 2 : Rectal spacer (RS): Biodegradable gel that is transperineally injected between the rectum and prostate under transrectal ultrasound guidance, to increase physical distance and thereby reduce radiation dose to the anterior rectal wall. The spacer begins to biodegrade in 2-3 months, and is fully absorbed within 6 months.
Patients on each arm will receive 5 fractions of radiation, 7.25Gy per fraction, delivered 2-3 times a week (every other day excluding weekends), to total dose of 36.25 Gy. The total duration of treatment will be no shorter than 10 days. Receives: Device: Rectal Spacer; Radiation: Radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Patient-reported Acute Toxicity Based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 4
To compare acute toxicity (as defined by CTCAE v4.0) and to compare Rectal dose (V35, max rectal dose). Acute radiation toxicities are side effects that occur on treatment or in the immediate post treatment period (within 90 days from the start of radiation treatment).
Measured: Baseline to 1 year
Secondary outcomes (4)
Measure the Effect of Treatment on Patients' Using Health Related Quality of Life Based on Expanded Prostate Cancer Index Composite Questionnaire
To compare health-related quality of life (HRQOL) measured using the Expanded Prostate Cancer Index Composite (EPIC) instrument for bowel, urinary and sexual domains. scores are transformed linearly to a 0-100 scale (see following page: EPIC scoring), with higher scores representing better HRQOL. American Urological Association (AUA) scores ranges from 0-30 scores where, score greater than 15 indicate high degree of urinary symptoms and scores less than 15 indicate low degree of urinary symptoms.
Measured: 1 year
Number of Participants With Recurrence-free Survival
1 year
Measured: 1 year
Comparing Several Parameters That Are Involved in Treatment Planning in Patients Randomized to Two Radiation Therapy Modalities.
To compare the dose distribution of the 2 techniques, specifically:
- coverage of the PTV
- DVH of organs at risk (OAR)
- prostate motion and shifts required during treatment
Measured: 5 years
Incidence of Patient-reported Toxicity (Late Toxicity) Based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 4
To compare late toxicity (as defined by CTCAE v4.0). Late toxicities are toxicities that occur greater than 3 months after radiation therapy completion.
Measured: post RT to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2016 (estimated)
- Study startSep 2016
- Primary completion17 Apr 2018
- Study completion17 Apr 2018
Why it stopped: Lack of patient accruals.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Josephine Kang, M.D., Principal investigator, Weill Cornell Medicine - New York Presbyterian HospitalSilvia Formenti, M.D., Principal investigator, Weill Cornell Medicine - New York Presbyterian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02911922
- Sponsor's protocol ID
- 1604017139
- Status last verified
- Apr 2019
- First submitted
- 19 Sep 2016
- Last updated
- 29 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Image -Guided Stereotactic Radiation Therapy (IG-SRT) in Prostate Cancer
- ClinicalTrials.gov ID
- NCT02911922
- Acronym / sponsor ID
- 1604017139
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of patient accruals.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- 17 Apr 2018 (actual)
- Study completion
- 17 Apr 2018 (actual)
- First posted
- 22 Sep 2016 (estimated)
- Results
- Posted 29 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with low-risk or favorable intermediate-risk prostate cancer as defined by 1.2016 NCCN criteria will be eligible to participate on this study.
Detailed description
This is a randomized, two arm study for patients with low-risk or favorable intermediate-risk prostate cancer as defined by 1.2016 NCCN criteria.
Patients will be randomized to either rectal spacer placement or endorectal balloon placement, daily prior to each radiation treatment.
- Endorectal balloon (ERB): Immobilization device manually placed into the rectum prior to radiation treatment planning CT and daily treatment delivery, to immobilize the prostate and reduce prostate motion.
- Rectal spacer (RS): Biodegradable gel that is transperineally injected between the rectum and prostate under transrectal ultrasound guidance, to increase physical distance and thereby reduce radiation dose to the anterior rectal wall. The spacer begins to biodegrade in 2-3 months, and is fully absorbed within 6 months.
This study plans to enroll a total of 40 patients with an accrual period of 4 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endorectal balloon - Radiation therapy | Experimental | Device: Endorectal Balloon, Radiation: Radiation therapyGroup 1 : Endorectal balloon (ERB): Immobilization device manually placed into the rectum prior to radiation treatment planning CT and daily treatment delivery, to immobilize the prostate and reduce prostate motion. Patients on each arm will receive 5 fractions of radiation, 7.25Gy per fraction, delivered 2-3 times a week (every other day excluding weekends), to total dose of 36.25 Gy. The total duration of treatment will be no shorter than 10 days. |
| Rectal spacer - Radiation therapy | Experimental | Device: Rectal Spacer, Radiation: Radiation therapyGroup 2 : Rectal spacer (RS): Biodegradable gel that is transperineally injected between the rectum and prostate under transrectal ultrasound guidance, to increase physical distance and thereby reduce radiation dose to the anterior rectal wall. The spacer begins to biodegrade in 2-3 months, and is fully absorbed within 6 months. Patients on each arm will receive 5 fractions of radiation, 7.25Gy per fraction, delivered 2-3 times a week (every other day excluding weekends), to total dose of 36.25 Gy. The total duration of treatment will be no shorter than 10 days. |
Who may qualify
- Ages
- 19 to 99 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Biopsy-proven diagnosis of prostate adenocarcinoma, diagnosed within 1 year of randomization
- Either NCCN-defined low-risk disease (T1c-T2a, Gleason score 3+3=6, PSA <10), intermediate-risk disease (Gleason score 3+4=7, 4+3=7, T2b-c and/or PSA 10-20; ) or high-risk disease due to Gleason score 8-10 and/or PSA >20 ng/ml, but not due to T3-T4 disease on physical exam.
Key exclusion criteria (8 listed)
- History of prior pelvic radiation (external beam or brachytherapy)
- Prior or concurrent lymphomatous/hematogenous malignancy, or history of prior/concurrent invasive malignancy during the past 5 years
- Very high risk prostate cancer (T3b-T4 on clinical exam, Primary Gleason pattern 5, or >4 cores with Gleason score 8-10)
- History of prior chemotherapy for prostate cancer
- History of irritable bowel disease
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 |
|---|---|---|
| Endorectal BalloonEndorectal balloon (ERB): Immobilization device manually placed into the rectum prior to radiation treatment planning CT and daily treatment delivery, to immobilize the prostate and reduce prostate motion. Patients on each arm will receive 5 fractions of radiation, 7.25Gy per fraction, delivered 2-3 times a week (every other day excluding weekends), to total dose of 36.25 Gy. The total duration of treatment will be no shorter than 10 days. | Device | Endorectal balloon - Radiation therapy |
| Rectal SpacerRectal spacer (RS): Biodegradable gel that is transperineally injected between the rectum and prostate under transrectal ultrasound guidance, to increase physical distance and thereby reduce radiation dose to the anterior rectal wall. The spacer begins to biodegrade in 2-3 months, and is fully absorbed within 6 months. Patients on each arm will receive 5 fractions of radiation, 7.25Gy per fraction, delivered 2-3 times a week (every other day excluding weekends), to total dose of 36.25 Gy. The total duration of treatment will be no shorter than 10 days. | Device | Rectal spacer - Radiation therapy |
| Radiation therapyPatients on each arm will receive 5 fractions of radiation, 7.25Gy per fraction, delivered 2-3 times a week (every other day excluding weekends), to total dose of 36.25 Gy. The total duration of treatment will be no shorter than 10 days. | Radiation | Endorectal balloon - Radiation therapy, Rectal spacer - Radiation therapy |
Primary outcome
Incidence of Patient-reported Acute Toxicity Based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 4
Time frame: Baseline to 1 year
To compare acute toxicity (as defined by CTCAE v4.0) and to compare Rectal dose (V35, max rectal dose). Acute radiation toxicities are side effects that occur on treatment or in the immediate post treatment period (within 90 days from the start of radiation treatment).
4 secondary outcomes
Measure the Effect of Treatment on Patients' Using Health Related Quality of Life Based on Expanded Prostate Cancer Index Composite Questionnaire
Time frame: 1 year
Number of Participants With Recurrence-free Survival
Time frame: 1 year
Comparing Several Parameters That Are Involved in Treatment Planning in Patients Randomized to Two Radiation Therapy Modalities.
Time frame: 5 years
Incidence of Patient-reported Toxicity (Late Toxicity) Based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 4
Time frame: post RT to 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Josephine Kang, M.D. principal investigator
Weill Cornell Medicine - New York Presbyterian Hospital
Silvia Formenti, M.D. principal investigator
Weill Cornell Medicine - New York Presbyterian Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endorectal Balloon, Rectal Spacer and Radiation therapy in people with Prostate Cancer, run by Weill Medical College of Cornell University at 1 site 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 2 inclusion and 8 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: stopped early, as of the sponsor's last update on 29 Apr 2019. 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 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Apr 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?
Incidence of Patient-reported Acute Toxicity Based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 4 (time frame: Baseline to 1 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 29 Apr 2019.