Prostate Cancer
Conditions
Brief 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.
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. 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. 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. This study plans to enroll a total of 40 patients with an accrual period of 4 years.
Interventions
DEVICEEndorectal 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.
DEVICERectal 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. 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.
RADIATIONRadiation therapy
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.
Sponsors
Weill Medical College of Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Patient-reported Acute Toxicity Based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 4 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measure the Effect of Treatment on Patients' Using Health Related Quality of Life Based on Expanded Prostate Cancer Index Composite Questionnaire | 1 year | 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. |
| 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. | 5 years | To compare the dose distribution of the 2 techniques, specifically: 1. coverage of the PTV 2. DVH of organs at risk (OAR) 3. prostate motion and shifts required during treatment |
| Incidence of Patient-reported Toxicity (Late Toxicity) Based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 4 | post RT to 1 year | To compare late toxicity (as defined by CTCAE v4.0). Late toxicities are toxicities that occur greater than 3 months after radiation therapy completion. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Measuring Number of Participants Changes in the Microbiome That is Associated With Normal Tissue Toxicities Resulting From Radiation From Baseline to End of Treatment | baseline, post radiation follow up | To explore microbiome changes associated with normal tissue toxicities resulting from radiation |
| Comparing Neutrophile:Lymphocyte Ratio (NLR) at Different Time Points to Assess Impact of SBRT in All the Participants | 1 month, 6 months, 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. |
Countries
United States
Participant flow
Recruitment details
One patient was enrolled on this study overall.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 1 |
| 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 |
| Total | 1 |
Baseline characteristics
| Characteristic | Rectal Spacer - Radiation Therapy | Total | Endorectal Balloon - Radiation Therapy |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | — | 70 years | 70 years |
| Comparing Neutrophil:Lymphocyte ratio | — | 2.23 Ratio | 2.23 Ratio |
| Health Related Quality of Life Based on Expanded Prostate Cancer Index Composite Question AUA scores | — | 6 units on a scale | 6 units on a scale |
| Health Related Quality of Life Based on Expanded Prostate Cancer Index Composite Question EPIC GI | — | 95.8 units on a scale | 100 units on a scale |
| Health Related Quality of Life Based on Expanded Prostate Cancer Index Composite Question EPIC GU | — | 93.8 units on a scale | 93.8 units on a scale |
| Health Related Quality of Life Based on Expanded Prostate Cancer Index Composite Question EPIC Sexual health | — | 100 units on a scale | 100 units on a scale |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | — | 1 participants | 1 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 0 |
| other Total, other adverse events | 0 / 1 | 0 / 0 |
| serious Total, serious adverse events | 0 / 1 | 0 / 0 |
Outcome results
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).
Time frame: Baseline to 1 year
Population: Data was not collected for the Rectal Spacer - Radiation Therapy arm because the trial was terminated due to lack of accrual.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Endorectal Balloon - Radiation Therapy | Incidence of Patient-reported Acute Toxicity Based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 4 | 1 Participants |
| Rectal Spacer - Radiation Therapy | Incidence of Patient-reported Acute Toxicity Based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 4 | 0 Participants |
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: 1. coverage of the PTV 2. DVH of organs at risk (OAR) 3. prostate motion and shifts required during treatment
Time frame: 5 years
Population: 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.
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.
Time frame: post RT to 1 year
Population: Data was not collected for the Rectal Spacer - Radiation Therapy arm because the trial was terminated due to lack of accrual.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Endorectal Balloon - Radiation Therapy | Incidence of Patient-reported Toxicity (Late Toxicity) Based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 4 | 1 Participants |
| Rectal Spacer - Radiation Therapy | Incidence of Patient-reported Toxicity (Late Toxicity) Based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 4 | 0 Participants |
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.
Time frame: 1 year
Population: Data was not collected for the Rectal Spacer - Radiation Therapy arm because the trial was terminated due to lack of accrual.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Endorectal Balloon - Radiation Therapy | Measure the Effect of Treatment on Patients' Using Health Related Quality of Life Based on Expanded Prostate Cancer Index Composite Questionnaire | EPIC GU (post treatment) | 100 units on a scale |
| Endorectal Balloon - Radiation Therapy | Measure the Effect of Treatment on Patients' Using Health Related Quality of Life Based on Expanded Prostate Cancer Index Composite Questionnaire | EPIC GI (post treatment) | 95.8 units on a scale |
| Endorectal Balloon - Radiation Therapy | Measure the Effect of Treatment on Patients' Using Health Related Quality of Life Based on Expanded Prostate Cancer Index Composite Questionnaire | EPIC Sexual health | NA units on a scale |
| Endorectal Balloon - Radiation Therapy | Measure the Effect of Treatment on Patients' Using Health Related Quality of Life Based on Expanded Prostate Cancer Index Composite Questionnaire | AUA scores | 2 units on a scale |
Secondary
Number of Participants With Recurrence-free Survival
1 year
Time frame: 1 year
Population: Data was not collected for the Rectal Spacer - Radiation Therapy arm because the trial was terminated due to lack of accrual.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Endorectal Balloon - Radiation Therapy | Number of Participants With Recurrence-free Survival | Baseline visit | 1 Participants |
| Endorectal Balloon - Radiation Therapy | Number of Participants With Recurrence-free Survival | 1 month post Radiation visit | 1 Participants |
| Endorectal Balloon - Radiation Therapy | Number of Participants With Recurrence-free Survival | 6 month post Radiation visit | 1 Participants |
| Endorectal Balloon - Radiation Therapy | Number of Participants With Recurrence-free Survival | 1 year post Radiation visit | 1 Participants |
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.
Time frame: 1 month, 6 months, 1 year
Population: Data was not collected for the Rectal Spacer - Radiation Therapy arm because the trial was terminated due to lack of accrual.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Endorectal Balloon - Radiation Therapy | Comparing Neutrophile:Lymphocyte Ratio (NLR) at Different Time Points to Assess Impact of SBRT in All the Participants | 1 month post radiation | 2.4 ratio |
| Endorectal Balloon - Radiation Therapy | Comparing Neutrophile:Lymphocyte Ratio (NLR) at Different Time Points to Assess Impact of SBRT in All the Participants | 6 month post radiation | 1.9 ratio |
| Endorectal Balloon - Radiation Therapy | Comparing Neutrophile:Lymphocyte Ratio (NLR) at Different Time Points to Assess Impact of SBRT in All the Participants | 1 year post (not collected) | NA ratio |
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
Time frame: baseline, post radiation follow up
Population: Data was not collected for both Endorectal balloon arm and the Rectal Spacer - Radiation Therapy arm.