Prostate Adenocarcinoma, Prostate Cancer
Conditions
Brief summary
1. Delivery of directed hypofractionated targeted (HT) radiotherapy (RT) tumor boost to the dominant tumor lesion in the prostate as identified by multiparametric MRI will increase tumor eradication from the prostate. 2. Biomarker expression levels differ in the multiparametric MRI defined regions at high risk of harboring tumors that determine outcome. 3. 10-15% of men undergoing RT have Circulating DNA or tumor cells (CTC) that are related to an adverse treatment outcome. 4. Quality of life will not differ significantly between the treatment arms. 5. Prostate cancer-related anxiety will be reduced in the HTIMRT arm, because the patients will be aware that the dominant tumor will be targeted with higher radiation dose.
Interventions
RADIATIONSIMRT
A total dose of 80 Gy will be delivered in 40 fractions to the Clinical Target Volume (CTV).
RADIATIONHTIMRT
Dose escalation to the Multiparametric MRI (MP-MRI) by dose painting at 2.35-2.40 Gy per fraction, while the rest of the Clinical Target Volume (CTV) receives 2.0 Gy a fraction to 76 Gy. The hypofractionated targeted (HT) boost region will receive an absolute dose of 89.3-91.2 Gy. Assuming an α/β ratio of 3.0, this would be equivalent to 95.5 Gy in 2.0 Gy fractions.
Sponsors
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
35 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* A. Biopsy confirmed adenocarcinoma of the prostate. * B. T1-T3a disease based on digital rectal exam. 1. T1a is permitted if peripheral zone biopsies are positive. 2. T3a disease based on MRI is acceptable. * C. No evidence of metastasis by any clinical criteria or available radiographic tests. * D. Gleason score 6-8. * E. Patients with Gleason score 8 must be offered long term androgen deprivation therapy (ADT) and refuse such treatment because only 4-6 (±2 months) months (short term ADT) is permitted on this protocol. Gleason score ≥ 8 patients should be recommended to receive short term ADT in conjunction with RT. When given, the ADT recommended to begin after fiducial marker placement, if applicable; however, ADT is permitted to have been started up to two months prior to the signing of consent. 1. Patients with Gleason score 8 disease must have \<40 of the diagnostic tumor tissue involved with tumor. 2. Patients with Gleason score ≤7 may be treated with 4-6 (±2 months) months of ADT. * F. PSA ≤100 ng/mL within 3 months of enrollment. If PSA was above 100 and dropped to ≤100 with antibiotics, this is acceptable for enrollment. * G. If PSA is \>15 ng/ml or there is ≥ Gleason 8 disease, a bone scan should be obtained ≤4 months before enrollment and should be without evidence of metastasis. A questionable bone scan is acceptable if plain x-rays, CT and/or MRI are negative for metastasis. * H. No previous pelvic radiotherapy * I. No previous history of radical/total prostatectomy (suprapubic prostatectomy is acceptable) * J. No concurrent, active malignancy, other than nonmetastatic skin cancer or early stage chronic lymphocytic leukemia (well-differentiated small cell lymphocytic lymphoma). If a prior malignancy is in remission for ≥ 5 years then the patient is eligible. * K. Identifiable multiparameter functional MRI defined tumor lesion or lesions using a 1.5T or 3.0T MRI (3.0T preferable), that total in volume \<33% of the prostate within 3 months prior to enrollment. a. Multiparametric functional including diffusion weighted imaging (DWI) of prostate and pelvis is required prior to protocol consideration * L. Ability to understand and the willingness to sign a written informed consent document * M. Zubrod performance status \<2 (Karnofsky or Eastern Cooperative Oncology Group (ECOG) performance status may be used to estimate Zubrod) * N. Willingness to fill out quality of life/psychosocial forms. * O. Age ≥35 and ≤85 years. * P. Serum testosterone is within 40% of normal assay limits (e.g., x=0.4\*lower assay limit and x=.04\*upper assay limit + upper assay limit),, taken within 4 months of enrollment. Patients who have been started on ADT prior to signing consent are not required to have a serum testosterone at this level prior to signing consent; but, a serum testosterone prior to fiducial marker placement is recommended. * Q. Serum liver function tests (LFTs) taken within 3 months of enrollment. * R. Complete blood counts taken within 3 months of enrollment.
Exclusion criteria
* A. Previous pelvic radiotherapy. * B. Previous history of radical prostatectomy. * C. Concurrent, active malignancy, which is not nonmetastatic skin cancer or early stage chronic lymphocytic leukemia (well-differentiated small cell lymphocytic lymphoma). If a prior malignancy is in remission for \< 5 years then the patient is not eligible * D. Not willing to fill out quality of life/psychosocial questionnaires.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Biopsy Failure | Up to 2.25 years | Number of participants showing positive prostate biopsy finding post treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | Up to 6 years | Mortality will be reported as overall survival and failure free survival. Overall survival is defined as the elapsed time from start of radiotherapy to death from any cause. Failure free survival is defined as the elapsed time from start of radiotherapy to first documented evidence of biochemical or clinical failure or death from any cause, whichever occurs first. In the absence of any event defining failure, follow-up time will be censored at the date of last documented failure-free status. |
| Failure Rate | Up to 6 years | Failure rate will be reported as the incidence of biochemical or clinical failure. Biochemical failure is defined is an increase of 2 or greater from nadir of Prostate Specific Antigen (PSA) levels. Clinical Failure is defined as newly identified extension outside the prostate after initial regression, or urinary obstructive symptoms with carcinoma or regional/distant failure due to radiographic evidence metastasis. |
| EPIC SF-12 Scores | At baseline, at last week of treatment (Up to 8 weeks), at 6 weeks after treatment (Up to 14 weeks), at 3 months after treatment (Up to 20 weeks), at 9 months after treatment (Up to 44 weeks). | Health-related Quality of Life (HRQOL) will be measured using the Expanded Prostate Cancer Index Composite and Medical Outcomes Study SF-12 (EPIC SF-12) to evaluate patient function and satisfaction after prostate cancer treatment. Response options for each item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better HRQOL. |
| Toxicity Rate | Up to 6 years | Toxicity rate will be reported as the number of participants experiencing any treatment-related adverse events. Acute and Late Toxicity will be evaluated by treating physician using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0. Acute toxicity will be defined as any treatment-related adverse event during and within 3 months of completing treatment. Late Toxicity will be defined as any treatment-related adverse events occurring more than 3 months after treatment completion. |
| Biomarker Expression in Prostate Tumor Regions | Up to 3 years | The amount of biomarker expression will be evaluated via immunohistochemistry (IHC) from ultrasound guided prostate biopsy tissue samples for both functional MRI suspicious regions and those that are not suspicious. |
| Incidence of Circulating Free DNA | Up to 3 years | Incidence of circulating free DNA, as assessed from blood samples. |
| MAX-PC Scores | At baseline, at last week of treatment (Up to 8 weeks), at 6 weeks after treatment (Up to 14 weeks), at 3 months after treatment (Up to 20 weeks), at 9 months after treatment (Up to 44 weeks) | Health-related quality of life (HRQOL) will be measured using the scores on the Modified 18-item Memorial Anxiety Scale for Prostate Cancer (MAX-PC). The scale consists of 18 items (e.g. I thought about prostate cancer even though I didn't mean to.) scored on a scale from 0 (not at all) to 3 (often). Total scores range from 0 to 54, with higher scores indicating higher levels of anxiety. |
Countries
United States
Participant flow
Recruitment details
Only 9 participants in Arm I and 7 participants in Arm II received study intervention.
Participants by arm
| Arm | Count |
|---|---|
| Arm I: SIMRT 'Participants in this group will receive the Standard Fractionated Intensity Modulated Radiotherapy (SIMRT) consisting 40 fractions over 8 weeks.
SIMRT: A total dose of 80 Gy will be delivered in 40 fractions to the Clinical Target Volume (CTV). | 9 |
| Arm II: HTIMRT Participants in this group will receive the Hypofractionated Targeted Intensity Modulated Radiotherapy (HTIMRT) consisting of 38 fractions over 7.5 weeks.
HTIMRT: Dose escalation to the Multiparametric MRI (MP-MRI) by dose painting at 2.35-2.40 Gy per fraction, while the rest of the Clinical Target Volume (CTV) receives 2.0 Gy a fraction to 76 Gy. The hypofractionated targeted (HT) boost region will receive an absolute dose of 89.3-91.2 Gy. Assuming an α/β ratio of 3.0, this would be equivalent to 95.5 Gy in 2.0 Gy fractions. | 9 |
| Total | 18 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Enrollment | Protocol Violation | 0 | 1 |
| Enrollment | Withdrawal by Subject | 0 | 1 |
| Treatment | Lost to Follow-up | 1 | 0 |
Baseline characteristics
| Characteristic | Arm I: SIMRT | Arm II: HTIMRT | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 8 Participants | 6 Participants | 14 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 3 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 5 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 4 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 9 Participants | 8 Participants | 17 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 9 Participants | 9 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 1 / 7 |
| other Total, other adverse events | 9 / 9 | 7 / 7 |
| serious Total, serious adverse events | 2 / 9 | 3 / 7 |
Outcome results
Primary
Number of Participants With Biopsy Failure
Number of participants showing positive prostate biopsy finding post treatment.
Time frame: Up to 2.25 years
Population: Of the 18 enrolled participants, only 16 participants were still enrolled at the 2.25 years follow up. Of the 16 participants, only 9 participants were able to complete the post treatment biopsy.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm I: SIMRT | Number of Participants With Biopsy Failure | 0 Participants |
| Arm II: HTIMRT | Number of Participants With Biopsy Failure | 2 Participants |
Secondary
Biomarker Expression in Prostate Tumor Regions
The amount of biomarker expression will be evaluated via immunohistochemistry (IHC) from ultrasound guided prostate biopsy tissue samples for both functional MRI suspicious regions and those that are not suspicious.
Time frame: Up to 3 years
Population: While tissue was collected for biomarker, none of the samples were analyzed because of insufficient patient numbers and power to draw conclusions. These types of analyses are done in batches and we never reached an appropriate threshold of cases to perform even exploratory analyses. No samples have been analyzed for biomarkers using IHC.
Secondary
EPIC SF-12 Scores
Health-related Quality of Life (HRQOL) will be measured using the Expanded Prostate Cancer Index Composite and Medical Outcomes Study SF-12 (EPIC SF-12) to evaluate patient function and satisfaction after prostate cancer treatment. Response options for each item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better HRQOL.
Time frame: At baseline, at last week of treatment (Up to 8 weeks), at 6 weeks after treatment (Up to 14 weeks), at 3 months after treatment (Up to 20 weeks), at 9 months after treatment (Up to 44 weeks).
Population: Only 16 participants received study intervention. Not all participants completed the survey at all time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm I: SIMRT | EPIC SF-12 Scores | Urinary Function (Incontinence): 6 weeks after treatment (Up to 14 weeks) | 87.3 score on a scale | Standard Deviation 14 |
| Arm I: SIMRT | EPIC SF-12 Scores | Bowel Habits: 3 months after treatment (Up to 20 weeks) | 95.8 score on a scale | Standard Deviation 7.5 |
| Arm I: SIMRT | EPIC SF-12 Scores | Urinary Symptoms (Irritative/Obstructive): 6 weeks after treatment (Up to 14 weeks) | 91.5 score on a scale | Standard Deviation 7.9 |
| Arm I: SIMRT | EPIC SF-12 Scores | Bowel Habits: 9 months after treatment (Up to 44 weeks) | 93.8 score on a scale | Standard Deviation 8 |
| Arm I: SIMRT | EPIC SF-12 Scores | Urinary Function (Incontinence): 9 months after treatment (Up to 44 weeks) | 88.8 score on a scale | Standard Deviation 12 |
| Arm I: SIMRT | EPIC SF-12 Scores | Sexual Function: Baseline (Prior to treatment) | 49.4 score on a scale | Standard Deviation 29.2 |
| Arm I: SIMRT | EPIC SF-12 Scores | Urinary Irritative/Obstructive: 3 months after treatment (Up to 20 weeks) | 93.3 score on a scale | Standard Deviation 12 |
| Arm I: SIMRT | EPIC SF-12 Scores | Sexual Function: Last week of treatment (Up to 8 weeks) | 41.5 score on a scale | Standard Deviation 29.6 |
| Arm I: SIMRT | EPIC SF-12 Scores | Urinary Function (Incontinence): Last week of treatment (Up to 8 weeks) | 82.2 score on a scale | Standard Deviation 23.9 |
| Arm I: SIMRT | EPIC SF-12 Scores | Sexual Function: 6 weeks after treatment (Up to 14 weeks) | 43.8 score on a scale | Standard Deviation 27.3 |
| Arm I: SIMRT | EPIC SF-12 Scores | Urinary Irritative/Obstructive: 9 months after treatment (Up to 44 weeks) | 95.6 score on a scale | Standard Deviation 5.6 |
| Arm I: SIMRT | EPIC SF-12 Scores | Sexual Function: 3 months after treatment (Up to 20 weeks) | 35.1 score on a scale | Standard Deviation 22.1 |
| Arm I: SIMRT | EPIC SF-12 Scores | Urinary Symptoms (Irritative/Obstructive): Baseline (Prior to treatment) | 92.1 score on a scale | Standard Deviation 5 |
| Arm I: SIMRT | EPIC SF-12 Scores | Sexual Function: 9 months after treatment (Up to 44 weeks) | 28 score on a scale | Standard Deviation 14.9 |
| Arm I: SIMRT | EPIC SF-12 Scores | Bowel Habits: Baseline (Prior to treatment) | 94.3 score on a scale | Standard Deviation 6.3 |
| Arm I: SIMRT | EPIC SF-12 Scores | Hormonal Function: Baseline (Prior to treatment) | 88.8 score on a scale | Standard Deviation 11.9 |
| Arm I: SIMRT | EPIC SF-12 Scores | Urinary Function (Incontinence): 3 months after treatment (Up to 20 weeks) | 93.8 score on a scale | Standard Deviation 10.8 |
| Arm I: SIMRT | EPIC SF-12 Scores | Hormonal Function: Last week of treatment (Up to 8 weeks) | 90 score on a scale | Standard Deviation 10.9 |
| Arm I: SIMRT | EPIC SF-12 Scores | Bowel Habits: Last week of treatment (Up to 8 weeks) | 90.3 score on a scale | Standard Deviation 13.7 |
| Arm I: SIMRT | EPIC SF-12 Scores | Hormonal Function: 6 weeks after treatment (Up to 14 weeks) | 84.4 score on a scale | Standard Deviation 14.9 |
| Arm I: SIMRT | EPIC SF-12 Scores | Urinary Symptoms (Irritative/Obstructive): Last week of treatment (Up to 8 weeks) | 81.1 score on a scale | Standard Deviation 17.6 |
| Arm I: SIMRT | EPIC SF-12 Scores | Hormonal Function: 3 months after treatment (Up to 20 weeks) | 89.4 score on a scale | Standard Deviation 16.8 |
| Arm I: SIMRT | EPIC SF-12 Scores | Bowel Habits: 6 weeks after treatment (Up to 14 weeks) | 98.4 score on a scale | Standard Deviation 2.2 |
| Arm I: SIMRT | EPIC SF-12 Scores | Hormonal Function: 9 months after treatment (Up to 44 weeks) | 91.9 score on a scale | Standard Deviation 11.3 |
| Arm I: SIMRT | EPIC SF-12 Scores | Urinary Function (Incontinence): Baseline (Prior to treatment) | 90.8 score on a scale | Standard Deviation 14.2 |
| Arm II: HTIMRT | EPIC SF-12 Scores | Hormonal Function: 9 months after treatment (Up to 44 weeks) | 83 score on a scale | Standard Deviation 14.4 |
| Arm II: HTIMRT | EPIC SF-12 Scores | Urinary Function (Incontinence): Baseline (Prior to treatment) | 89.3 score on a scale | Standard Deviation 15.7 |
| Arm II: HTIMRT | EPIC SF-12 Scores | Urinary Function (Incontinence): Last week of treatment (Up to 8 weeks) | 84.8 score on a scale | Standard Deviation 27.1 |
| Arm II: HTIMRT | EPIC SF-12 Scores | Urinary Function (Incontinence): 6 weeks after treatment (Up to 14 weeks) | 82.1 score on a scale | Standard Deviation 24.5 |
| Arm II: HTIMRT | EPIC SF-12 Scores | Urinary Function (Incontinence): 3 months after treatment (Up to 20 weeks) | 93.2 score on a scale | Standard Deviation 12.8 |
| Arm II: HTIMRT | EPIC SF-12 Scores | Urinary Function (Incontinence): 9 months after treatment (Up to 44 weeks) | 83.8 score on a scale | Standard Deviation 15.2 |
| Arm II: HTIMRT | EPIC SF-12 Scores | Urinary Symptoms (Irritative/Obstructive): Baseline (Prior to treatment) | 82.1 score on a scale | Standard Deviation 19.5 |
| Arm II: HTIMRT | EPIC SF-12 Scores | Urinary Symptoms (Irritative/Obstructive): Last week of treatment (Up to 8 weeks) | 73.6 score on a scale | Standard Deviation 25.6 |
| Arm II: HTIMRT | EPIC SF-12 Scores | Urinary Symptoms (Irritative/Obstructive): 6 weeks after treatment (Up to 14 weeks) | 82.1 score on a scale | Standard Deviation 22.9 |
| Arm II: HTIMRT | EPIC SF-12 Scores | Urinary Irritative/Obstructive: 3 months after treatment (Up to 20 weeks) | 89.3 score on a scale | Standard Deviation 12.4 |
| Arm II: HTIMRT | EPIC SF-12 Scores | Urinary Irritative/Obstructive: 9 months after treatment (Up to 44 weeks) | 79 score on a scale | Standard Deviation 16 |
| Arm II: HTIMRT | EPIC SF-12 Scores | Bowel Habits: Baseline (Prior to treatment) | 88.7 score on a scale | Standard Deviation 15.9 |
| Arm II: HTIMRT | EPIC SF-12 Scores | Bowel Habits: Last week of treatment (Up to 8 weeks) | 92.3 score on a scale | Standard Deviation 5.6 |
| Arm II: HTIMRT | EPIC SF-12 Scores | Bowel Habits: 6 weeks after treatment (Up to 14 weeks) | 94 score on a scale | Standard Deviation 6.7 |
| Arm II: HTIMRT | EPIC SF-12 Scores | Bowel Habits: 3 months after treatment (Up to 20 weeks) | 96.4 score on a scale | Standard Deviation 4.5 |
| Arm II: HTIMRT | EPIC SF-12 Scores | Bowel Habits: 9 months after treatment (Up to 44 weeks) | 86.5 score on a scale | Standard Deviation 9.2 |
| Arm II: HTIMRT | EPIC SF-12 Scores | Sexual Function: Baseline (Prior to treatment) | 37.5 score on a scale | Standard Deviation 32.7 |
| Arm II: HTIMRT | EPIC SF-12 Scores | Sexual Function: Last week of treatment (Up to 8 weeks) | 35.9 score on a scale | Standard Deviation 30.1 |
| Arm II: HTIMRT | EPIC SF-12 Scores | Sexual Function: 6 weeks after treatment (Up to 14 weeks) | 33.6 score on a scale | Standard Deviation 31.2 |
| Arm II: HTIMRT | EPIC SF-12 Scores | Sexual Function: 3 months after treatment (Up to 20 weeks) | 40.3 score on a scale | Standard Deviation 37.9 |
| Arm II: HTIMRT | EPIC SF-12 Scores | Sexual Function: 9 months after treatment (Up to 44 weeks) | 44.8 score on a scale | Standard Deviation 40 |
| Arm II: HTIMRT | EPIC SF-12 Scores | Hormonal Function: Baseline (Prior to treatment) | 77.9 score on a scale | Standard Deviation 25.3 |
| Arm II: HTIMRT | EPIC SF-12 Scores | Hormonal Function: Last week of treatment (Up to 8 weeks) | 79.3 score on a scale | Standard Deviation 25.6 |
| Arm II: HTIMRT | EPIC SF-12 Scores | Hormonal Function: 6 weeks after treatment (Up to 14 weeks) | 71.4 score on a scale | Standard Deviation 18.2 |
| Arm II: HTIMRT | EPIC SF-12 Scores | Hormonal Function: 3 months after treatment (Up to 20 weeks) | 79.3 score on a scale | Standard Deviation 16.4 |
Secondary
Failure Rate
Failure rate will be reported as the incidence of biochemical or clinical failure. Biochemical failure is defined is an increase of 2 or greater from nadir of Prostate Specific Antigen (PSA) levels. Clinical Failure is defined as newly identified extension outside the prostate after initial regression, or urinary obstructive symptoms with carcinoma or regional/distant failure due to radiographic evidence metastasis.
Time frame: Up to 6 years
Population: Only 16 participants received study intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm I: SIMRT | Failure Rate | Biochemical Failure | 0 Participants |
| Arm I: SIMRT | Failure Rate | Clinical Failure | 0 Participants |
| Arm II: HTIMRT | Failure Rate | Biochemical Failure | 0 Participants |
| Arm II: HTIMRT | Failure Rate | Clinical Failure | 0 Participants |
Secondary
Incidence of Circulating Free DNA
Incidence of circulating free DNA, as assessed from blood samples.
Time frame: Up to 3 years
Population: While blood was collected for cfDNA assessment, none of the samples were analyzed because of insufficient patient numbers and power to draw conclusions. These types of analyses are done in batches and we never reached an appropriate threshold of cases to perform even exploratory analyses. No samples have been analyzed for cfDNA.
Secondary
MAX-PC Scores
Health-related quality of life (HRQOL) will be measured using the scores on the Modified 18-item Memorial Anxiety Scale for Prostate Cancer (MAX-PC). The scale consists of 18 items (e.g. I thought about prostate cancer even though I didn't mean to.) scored on a scale from 0 (not at all) to 3 (often). Total scores range from 0 to 54, with higher scores indicating higher levels of anxiety.
Time frame: At baseline, at last week of treatment (Up to 8 weeks), at 6 weeks after treatment (Up to 14 weeks), at 3 months after treatment (Up to 20 weeks), at 9 months after treatment (Up to 44 weeks)
Population: Only 16 participants received study intervention. Not all participants completed the survey at all time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm I: SIMRT | MAX-PC Scores | Last week of treatment (Up to 8 weeks) | 12.3 score on a scale | Standard Deviation 7.7 |
| Arm I: SIMRT | MAX-PC Scores | 3 months after treatment (Up to 20 weeks) | 10.6 score on a scale | Standard Deviation 5 |
| Arm I: SIMRT | MAX-PC Scores | 6 weeks after treatment (Up to 14 weeks) | 12.9 score on a scale | Standard Deviation 3.3 |
| Arm I: SIMRT | MAX-PC Scores | 9 months after treatment (Up to 44 weeks) | 10.0 score on a scale | Standard Deviation 6.8 |
| Arm I: SIMRT | MAX-PC Scores | Baseline (Prior to treatment) | 10.6 score on a scale | Standard Deviation 9 |
| Arm II: HTIMRT | MAX-PC Scores | 9 months after treatment (Up to 44 weeks) | 9.6 score on a scale | Standard Deviation 1.5 |
| Arm II: HTIMRT | MAX-PC Scores | Baseline (Prior to treatment) | 16.6 score on a scale | Standard Deviation 9.2 |
| Arm II: HTIMRT | MAX-PC Scores | Last week of treatment (Up to 8 weeks) | 13.9 score on a scale | Standard Deviation 7.9 |
| Arm II: HTIMRT | MAX-PC Scores | 6 weeks after treatment (Up to 14 weeks) | 13.0 score on a scale | Standard Deviation 8.1 |
| Arm II: HTIMRT | MAX-PC Scores | 3 months after treatment (Up to 20 weeks) | 11.3 score on a scale | Standard Deviation 3.5 |
Secondary
Mortality
Mortality will be reported as overall survival and failure free survival. Overall survival is defined as the elapsed time from start of radiotherapy to death from any cause. Failure free survival is defined as the elapsed time from start of radiotherapy to first documented evidence of biochemical or clinical failure or death from any cause, whichever occurs first. In the absence of any event defining failure, follow-up time will be censored at the date of last documented failure-free status.
Time frame: Up to 6 years
Population: Only 16 participants received study intervention.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Arm I: SIMRT | Mortality | Failure Free Survival | 64.9 months |
| Arm I: SIMRT | Mortality | Overall Survival | 64.9 months |
| Arm II: HTIMRT | Mortality | Failure Free Survival | 65.0 months |
| Arm II: HTIMRT | Mortality | Overall Survival | 65.0 months |
Secondary
Toxicity Rate
Toxicity rate will be reported as the number of participants experiencing any treatment-related adverse events. Acute and Late Toxicity will be evaluated by treating physician using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0. Acute toxicity will be defined as any treatment-related adverse event during and within 3 months of completing treatment. Late Toxicity will be defined as any treatment-related adverse events occurring more than 3 months after treatment completion.
Time frame: Up to 6 years
Population: Only 16 participants received study intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm I: SIMRT | Toxicity Rate | Treatment-related Acute Toxicity (<=3 months of completing treatment) | 9 Participants |
| Arm I: SIMRT | Toxicity Rate | Treatment-related Late Toxicity (>3 months after completing treatment) | 7 Participants |
| Arm I: SIMRT | Toxicity Rate | Treatment-related Grade 3 or higher Acute Toxicity | 0 Participants |
| Arm I: SIMRT | Toxicity Rate | Treatment-related Grade 3 or higher Late Toxicity | 1 Participants |
| Arm I: SIMRT | Toxicity Rate | Treatment-related Serious Adverse Events (SAEs) | 1 Participants |
| Arm II: HTIMRT | Toxicity Rate | Treatment-related Grade 3 or higher Late Toxicity | 0 Participants |
| Arm II: HTIMRT | Toxicity Rate | Treatment-related Serious Adverse Events (SAEs) | 0 Participants |
| Arm II: HTIMRT | Toxicity Rate | Treatment-related Acute Toxicity (<=3 months of completing treatment) | 7 Participants |
| Arm II: HTIMRT | Toxicity Rate | Treatment-related Grade 3 or higher Acute Toxicity | 0 Participants |
| Arm II: HTIMRT | Toxicity Rate | Treatment-related Late Toxicity (>3 months after completing treatment) | 5 Participants |