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Lack of patient accruals.
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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.
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.
This study plans to enroll a total of 40 patients with an accrual period of 4 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endorectal Balloon | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Measuring Number of Participants Changes in the Microbiome That is Associated With Normal Tissue Toxicities Resulting From Radiation From Baseline to End of Treatment | To explore microbiome changes associated with normal tissue toxicities resulting from radiation | baseline, post radiation follow up |
| Comparing Neutrophile:Lymphocyte Ratio (NLR) at Different Time Points to Assess Impact of SBRT in All the Participants |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Josephine Kang, M.D. | Weill Cornell Medicine - New York Presbyterian Hospital | Principal Investigator |
| Silvia Formenti, M.D. | Weill Cornell Medicine - New York Presbyterian Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medicine | New York | New York | 10065 | United States |
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One patient was enrolled on this study overall.
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| ID | Title | Description |
|---|---|---|
| FG000 | Endorectal Balloon - Radiation Therapy | 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. Endorectal Balloon: 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. |
| FG001 | Rectal Spacer - Radiation Therapy | 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. Rectal Spacer: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The study accrued only one patient . 0(zero) subjects were analyzed in the rectal spacer arm due to lack of accrual.
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| ID | Title | Description |
|---|---|---|
| BG000 | Endorectal Balloon - Radiation Therapy | 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. Endorectal Balloon: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Data was not collected for the Rectal Spacer - Radiation Therapy arm because the trial was terminated due to lack of accrual. | Posted | Count of Participants | Participants | Baseline to 1 year |
|
The adverse events were collected over a time period of 1 year.
The adverse events were collected based on the CTCAEv4.03. 0 subjects at risk in the rectal spacer - radiation therapy arm because the trial was closed due to lack of accrual.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Endorectal Balloon - Radiation Therapy | 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. Endorectal Balloon: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Josephine Kang, M.D. Ph.D. | Weill Cornell Medicine - New York Presbyterian Hospital | 212-746-3607 | jok9106@med.cornell.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 24, 2016 | Jan 24, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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|
| Rectal Spacer | Device | 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 therapy | Radiation | 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. |
|
| 1 year |
| Number of Participants With Recurrence-free Survival | 1 year | 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:
| 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. | post RT to 1 year |
Comparing NLR ratio at different timepoints to assess the impact of radiation therapy on patients. A neutrophil:lymphocyte ratio (NLR) > 4 at time radiotherapy predicts for significantly worse prognosis, when compared to NLR < 4. |
| 1 month, 6 months, 1 year |
| BG001 | Rectal Spacer - Radiation Therapy | 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. Rectal Spacer: 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Health Related Quality of Life Based on Expanded Prostate Cancer Index Composite Question | Measure the effect of treatment on patients using Health related Quality of Life based on Expanded Prostate Cancer Index Composite Question. For EPIC GU, EPIC GI and Sexual Health higher (range 0-100) scores represent Good quality of life. For AUA scores ( range 0-35), Lower scores represent less urinary symptoms. | Number | units on a scale |
|
| Comparing Neutrophil:Lymphocyte ratio | Number | Ratio |
|
| OG001 | Rectal Spacer - Radiation Therapy | 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. Rectal Spacer: 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. |
|
|
| Secondary | 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. | Data was not collected for the Rectal Spacer - Radiation Therapy arm because the trial was terminated due to lack of accrual. | Posted | Number | units on a scale | 1 year |
|
|
|
| Secondary | Number of Participants With Recurrence-free Survival | 1 year | Data was not collected for the Rectal Spacer - Radiation Therapy arm because the trial was terminated due to lack of accrual. | Posted | Count of Participants | Participants | 1 year |
|
|
|
| Secondary | 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:
| Data could not be analyzed for the secondary outcome measure as we needed more than one patient to compare two radiation techniques. The trial was terminated due to lack of accrual. | Posted | 5 years |
|
|
| Secondary | 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. | Data was not collected for the Rectal Spacer - Radiation Therapy arm because the trial was terminated due to lack of accrual. | Posted | Count of Participants | Participants | post RT to 1 year |
|
|
|
| Other Pre-specified | Measuring Number of Participants Changes in the Microbiome That is Associated With Normal Tissue Toxicities Resulting From Radiation From Baseline to End of Treatment | To explore microbiome changes associated with normal tissue toxicities resulting from radiation | Data was not collected for both Endorectal balloon arm and the Rectal Spacer - Radiation Therapy arm. | Posted | baseline, post radiation follow up |
|
|
| Other Pre-specified | Comparing Neutrophile:Lymphocyte Ratio (NLR) at Different Time Points to Assess Impact of SBRT in All the Participants | Comparing NLR ratio at different timepoints to assess the impact of radiation therapy on patients. A neutrophil:lymphocyte ratio (NLR) > 4 at time radiotherapy predicts for significantly worse prognosis, when compared to NLR < 4. | Data was not collected for the Rectal Spacer - Radiation Therapy arm because the trial was terminated due to lack of accrual. | Posted | Number | ratio | 1 month, 6 months, 1 year |
|
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | Rectal Spacer - Radiation Therapy | 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. Rectal Spacer: 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. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| Title | Measurements |
|---|---|
|
| AUA scores |
|
| Title | Measurements |
|---|---|
|
| 1 year post Radiation visit |
|
| Title | Measurements |
|---|---|
|