Cancer Of Prostate, Neoplasms of Prostate, Prostate Cancer, Prostate Neoplasms, Prostatic Cancer
Conditions
Keywords
Rising PSA, No evidence of metastatic disease, Entire Prostate Bed, Quality of Life, Irradiation
Brief summary
Background: Sometimes prostate cancer comes back after a person's prostate is removed. In this case, radiation is a common treatment. Radiation kills prostate cancer cells. It can be very effective. It is usually given in short doses almost every day for 6 or 7 weeks. Researchers want to see if a shorter schedule can be as effective. They want to see if that causes the same or fewer side effects. Usually, radiation is used to treat the entire area where the prostate was before surgery. In some patients, an area of tumor can be seen on scans. Researchers are also trying to see if they can give less dose to the area usually treated with radiation if the full dose is given to the tumor seen on scans. Objective: To find the shortest radiation schedule that people can tolerate without strong side effects. Eligibility: People at least 18 years old who have had a prostatectomy and will get radiation. Design: Participants will be screened with: * Medical history * Physical exam * Blood and urine tests * Scan that uses a small amount of radiation to make a picture of the body * Scan that uses a magnetic field to make an image of the body * Participants will provide documents that confirm their diagnosis. * Participants may have a scan of the abdomen and pelvis. Before they start treatment, participants will have another physical exam and blood tests. Participants will get radiation each day Monday through Friday. Treatment may last 2, 3, or 4 weeks. Participants may provide a tissue sample from a previous procedure for research. Participants will answer questions about their general well-being and function. About 4-5 weeks after they finish radiation treatment, participants will have a follow-up visit. They will be examined and give a blood sample. They will have 6 follow-up visits for the next 2 years.
Detailed description
BACKGROUND: Prostate cancer that recurs after prostatectomy (rising prostate-specific antigen (PSA) with no evidence of metastatic disease is often treated with radiation to the entire prostate bed to a dose of 66-72 Gray (Gy) over 6-7 weeks. This treatment can provide PSA control in approximately 75% of patients but may have associated genitourinary and gastrointestinal toxicity due to irradiation of the rectum, small bowel, and bladder. Imaging of prostate cancer has improved to the extent that recurrent disease is often identified in the prostate bed or in other pelvic sites. The current standard is to irradiate the entire prostate bed to the total dose. This trial will test the tolerability of accelerated treatment designed to yield a similar rate of late toxicity. In addition, in patients with visible tumor, it will test the feasibility of delivering a lower dose to the prostate bed and an integrated boost (simultaneous) to the visible tumor to allow a higher dose to visible tumor than can be delivered with standard approaches. OBJECTIVE: \- Define the maximum tolerated dose (MTD) hypofractionation of image guided, focally dose escalated post-prostatectomy radiation. ELIGIBILITY: * PSA recurrence after prostatectomy or indications for adjuvant radiation after prostatectomy. * No evidence of distant metastases of prostate cancer (pelvic lymph nodes are allowed). * Age greater than or equal to 18 years old * Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 1 DESIGN: This is a Phase I trial of hypofractionated focal dose escalation with reduced dose prostate bed irradiation using image and pathologic guidance. The prostate bed will be treated with hypofractionated radiation and areas in the prostate bed or pelvis shown to have tumor on biopsy or with advanced imaging studies will be treated with an integrated boost to visible tumor. The treatment duration will be decreased sequentially in three Dose Level groups. Quality of life and functional outcomes such as urine, bowel, and erectile function will be assessed with questionnaires. A maximum of 48 patients will be enrolled.
Interventions
RADIATIONProstate bed with integrated boost
Radiation will be delivered at an escalated dose to areas of recurrent prostate cancer identified on imaging and a reduced dose will be delivered to the entire prostate bed.
RADIATIONProstate bed irradiation only
Radiation will be delivered to the prostate bed only.
DIAGNOSTIC_TESTWhole Body Bone Scan
At screening, if required by clinician.
DIAGNOSTIC_TEST18F-NaF PET Imaging
At screening, if required by clinician.
DIAGNOSTIC_TESTCT
Computed tomography of the abdomen and pelvis if clinically indicated at screening, with oral and intravenous contrast.
DIAGNOSTIC_TESTmpMRI
mpMRI of the prostate bed at screening and 6 month follow up.
DRUGADT
After enrollment if clinically indicated (i.e., anti-androgen, gonadotropin releasing hormone agonist, or combination of both).
Sponsors
National Cancer Institute (NCI)
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* INCLUSION CRITERIA: * Patients must have histologically or cytologically confirmed adenocarcinoma of the prostate. * Indications for post-prostatectomy radiation exist: * Disease progression (detectable prostate-specific antigen (PSA) on two measurements obtained at least one month apart) or * indications for adjuvant radiation exist (if undetectable PSA): pathologic T3, T4, N+ disease or positive margins (within 1 year of prostatectomy). * Age greater than or equal to 18 years. * Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 1 (Karnofsky greater than or equal to 60) * Ability of subject to understand and the willingness to sign a written informed consent document. * Radiation is teratogenic; thus, men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and up to 120 days after the last radiation. Should a woman become pregnant or suspect she is pregnant while her partner is participating in this study, she should inform her treating physician immediately. * Human immunodeficiency virus (HIV) positive patients are included if CD4+ (cytotoxic T cells) T-cell count \> 200 cells/uL; on stable antiretroviral therapy for \> 1 year with HIV viral load \<200 copies/mL, and no history of opportunistic infections in \> 1 year.
Exclusion criteria
* Patients who are receiving any other investigational agents concurrently. * Documented metastases of prostate cancer outside of the pelvis (pelvic lymph nodes are allowed only if within the prostate bed region). * History of radiation that would overlap with the intended treatment to the prostate bed. * Known contraindications to radiation such as inflammatory bowel disease, active systemic lupus or scleroderma, or radiation hypersensitivity syndrome (Ataxia Telangiectasia or Fanconi's Anemia) * Subjects with any coexisting medical or psychiatric condition which, in the opinion of the Investigator likely to interfere with study procedures and/or results. * Medically indicated use of known radiosensitizing drugs (such as protease inhibitors)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Tolerated Dose (MTD) of Radiation Dose to Prostate Bed and Dose to Tumor Reported in Gray (Gy) | 3 weeks after radiation | Maximum tolerated dose (MTD) of image guided hypofractionated, focally dose escalated post-prostatectomy radiation is defined as the dose level at which no more than 1 of up to 6 participants experience dose limiting toxicity (DLT) during the DLT period, and the dose below that at which at least 2 (of ≤6) participants have DLT as a result of treatment. A DLT is defined as any of the following: Grade 3 rectal, small bowel, or urinary toxicity that does not resolve to Grade 2 or less within 4 days with appropriate medical management. Other grade 3 in-field toxicities attributable to radiation that does not resolve to Grade 2 or less within 4 days with appropriate medical management. And delays of more than one week in completing radiation treatment due to toxicity. |
| Maximum Tolerated Dose (MTD) of Radiation Dose to Prostate Bed and Dose to Tumor Reported in Fractions | 3 weeks after radiation | Maximum tolerated dose (MTD) of image guided hypofractionated, focally dose escalated post-prostatectomy radiation is defined as the dose level at which no more than 1 of up to 6 participants experience dose limiting toxicity (DLT) during the DLT period, and the dose below that at which at least 2 (of ≤6) participants have DLT as a result of treatment. A DLT is defined as any of the following: Grade 3 rectal, small bowel, or urinary toxicity that does not resolve to Grade 2 or less within 4 days with appropriate medical management. Other grade 3 in-field toxicities attributable to radiation that does not resolve to Grade 2 or less within 4 days with appropriate medical management. And delays of more than one week in completing radiation treatment due to toxicity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biochemical Progression Free Survival (bPFS) | 1 and 2 years after treatment | bPFS is defined as the percent of participants without evidence of (prostate-specific antigen) PSA progression or death. PSA progression (also known as biochemical failure) is defined based on elevation of PSA above 0.1 ng/dL. Kaplan-Meier survival analysis will be used to report bPFS. |
| Changes in Erectile Dysfunction QOL Scores During and After Treatment Measured by the Sexual Health Inventory for Men (SHIM) | Baseline compared to 24 months after treatment | Changes before and after treatment with prostate bed radiation in participant reported outcomes (Sexual Health Inventory for Men (SHIM). The QOL scores will be summarized at baseline and after treatment. Linear mixed effects model will be used to model quality of life scores at baseline and during and after treatment in which random intercept and random slope are used to account for participant-specific trajectory of QOL scores. The SHIM is a 5-question quiz used to identify erectile dysfunction and assess its severity. The composite score is generated by adding the score for each question. The total score can range from 1-25. Higer values represent better erectile function. |
| Changes of American Urologic Association (AUA) Symptom Index Quality of Life (QOL) Scores During and After Treatment | Baseline compared to 24 months after treatment | Changes of QOL scores during and after treatment with prostate bed radiation in American Urologic Association (AUA) Symptom Index. The QOL scores will be summarized at baseline and for each visit. Linear mixed effects model will be used to model quality of life scores at baseline and during and after treatment in which random intercept and random slope are used to account for participant-specific trajectory of QOL scores. The AUA Symptom Index is a 7-question quiz used to identify urinary symptoms and assess severity. Each question is scored based on the frequency of different urinary symptoms. The composite score is generated by adding the score for each question. The total score can range from 0-35. Lower values represent less symptoms. |
| Changes of Expanded Prostate Cancer Index Composite (EPIC-26) Quality of Life (QOL) Scores During and After Treatment | Baseline compared to 24 months after treatment | Changes of QOL scores during and after treatment of focally dose escalated prostate stereotactic body radiation therapy on participant(pt) reported outcomes, EPIC-26 in pts previously treated with radiotherapy. The QOL scores will be summarized at baseline and for each visit. Linear mixed effects model will be used to model QOL scores at baseline and during and after treatment in which random intercept and random slope are used to account for pt-specific trajectory of QOL scores. The EPIC-26 is a shortened, validated questionnaire used to assess health related QOL in individuals with prostate cancer. EPIC26 measures sexual function, bowel function, hormone therapy side effects, urinary incontinence, and urinary irritative symptoms. The survey has 26 individual items that have 4 to 5 response options that reflect a range of function from poor to excellent. EPIC26 uses a Likert scale for each item, and scores are transformed to a 0-100 scale, with higher scores indicating better HRQOL. |
| Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | 3 weeks after radiation | Grade 2-5 serious and/or non-serious adverse events attributable to protocol treatment. A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. Grade 2 is moderate. Grade 3 is serious. Grade 4 is life-threatening. And Grade 5 is death related to adverse event. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDeborah E Citrin, M.D.
National Cancer Institute (NCI)
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| LEVEL 1/ COHORT 1: Recurrent Tumor Visible; Prostate Bed With Integrated Boost - 20 Fractions LEVEL 1/ COHORT 1: Recurrent tumor visible; prostate bed with integrated boost. 20 fractions: Dose to prostate bed 45.8 Gray (Gy) in 2.29 Gy fractions; Dose to tumor 60.4 Gy in 3.02 Gy fractions. | 3 |
| LEVEL 2/ COHORT 1: Recurrent Tumor Visible; Prostate Bed With Integrated Boost - 15 Fractions LEVEL 2/ COHORT 1: Recurrent tumor visible, prostate bed with integrated boost. 15 fractions: Dose to prostate bed 41.85 Gray (Gy) in 2.79 Gy fractions; Dose to tumor 54.6 Gy in 3.64 Gy fractions. | 3 |
| LEVEL 3/ COHORT 1: Recurrent Tumor Visible; Prostate Bed With Integrated Boost - 10 Fractions LEVEL 3/ COHORT 1: Recurrent tumor visible, prostate bed with integrated boost. 10 fractions: Dose to prostate bed 36.4 Gray (Gy) in 3.64 Gy fractions; Dose to tumor 47.1 Gy in 4.71 Gy fractions. | 9 |
| LEVEL 1/ COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 20 Fractions LEVEL 1/ COHORT 2: Recurrent tumor NOT visible, prostate bed irradiation only. 20 fractions: Dose to prostate bed 56.4 Gray (Gy) in 2.82 Gy fractions. | 3 |
| LEVEL 2/ COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 15 Fractions LEVEL 2/ COHORT 2: Recurrent tumor NOT visible, prostate bed irradiation only. 15 fractions: Dose to prostate bed 51.2 Gray (Gy) in 3.41 Gy fractions. | 3 |
| LEVEL 3/ COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 10 Fractions LEVEL 3/ COHORT 2: Recurrent tumor NOT visible, prostate bed irradiation only. 10 fractions: Dose to prostate bed 44.2 Gray (Gy) in 4.42 Gy fractions. | 9 |
| Total | 30 |
Baseline characteristics
| Characteristic | LEVEL 2/ COHORT 1: Recurrent Tumor Visible; Prostate Bed With Integrated Boost - 15 Fractions | LEVEL 3/ COHORT 1: Recurrent Tumor Visible; Prostate Bed With Integrated Boost - 10 Fractions | LEVEL 1/ COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 20 Fractions | LEVEL 2/ COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 15 Fractions | LEVEL 3/ COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 10 Fractions | LEVEL 1/ COHORT 1: Recurrent Tumor Visible; Prostate Bed With Integrated Boost - 20 Fractions | Total |
|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 6 Participants | 2 Participants | 3 Participants | 5 Participants | 2 Participants | 20 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 3 Participants | 1 Participants | 0 Participants | 4 Participants | 1 Participants | 10 Participants |
| Age, Continuous | 67.4 years STANDARD_DEVIATION 3.02 | 67.04 years STANDARD_DEVIATION 7.51 | 67.63 years STANDARD_DEVIATION 9.87 | 70.87 years STANDARD_DEVIATION 1.61 | 64.32 years STANDARD_DEVIATION 10.4 | 65.63 years STANDARD_DEVIATION 7.35 | 66.56 years STANDARD_DEVIATION 7.78 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 9 Participants | 3 Participants | 3 Participants | 8 Participants | 3 Participants | 29 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 3 Participants | 0 Participants | 1 Participants | 2 Participants | 2 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 6 Participants | 3 Participants | 2 Participants | 7 Participants | 1 Participants | 22 Participants |
| Region of Enrollment United States | 3 participants | 9 participants | 3 participants | 3 participants | 9 participants | 3 participants | 30 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 3 Participants | 9 Participants | 3 Participants | 3 Participants | 9 Participants | 3 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 3 | 0 / 9 | 0 / 3 | 0 / 3 | 0 / 9 |
| other Total, other adverse events | 3 / 3 | 3 / 3 | 8 / 9 | 3 / 3 | 3 / 3 | 9 / 9 |
| serious Total, serious adverse events | 0 / 3 | 0 / 3 | 0 / 9 | 1 / 3 | 0 / 3 | 0 / 9 |
Outcome results
Primary
Maximum Tolerated Dose (MTD) of Radiation Dose to Prostate Bed and Dose to Tumor Reported in Fractions
Maximum tolerated dose (MTD) of image guided hypofractionated, focally dose escalated post-prostatectomy radiation is defined as the dose level at which no more than 1 of up to 6 participants experience dose limiting toxicity (DLT) during the DLT period, and the dose below that at which at least 2 (of ≤6) participants have DLT as a result of treatment. A DLT is defined as any of the following: Grade 3 rectal, small bowel, or urinary toxicity that does not resolve to Grade 2 or less within 4 days with appropriate medical management. Other grade 3 in-field toxicities attributable to radiation that does not resolve to Grade 2 or less within 4 days with appropriate medical management. And delays of more than one week in completing radiation treatment due to toxicity.
Time frame: 3 weeks after radiation
Population: 12/30 expansion group participants (6 in Recurrent Tumor Visible: Level 3 Cohort 1, and Recurrent Tumor NOT Visible: Level 3 Cohort 2) were not assessed for MTD and included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants With Recurrent Tumor Visible | Maximum Tolerated Dose (MTD) of Radiation Dose to Prostate Bed and Dose to Tumor Reported in Fractions | Dose to prostate bed | 3.64 Fractions |
| All Participants With Recurrent Tumor Visible | Maximum Tolerated Dose (MTD) of Radiation Dose to Prostate Bed and Dose to Tumor Reported in Fractions | Dose to tumor | 4.71 Fractions |
| All Participants With Recurrent Tumor NOT Visible | Maximum Tolerated Dose (MTD) of Radiation Dose to Prostate Bed and Dose to Tumor Reported in Fractions | Dose to prostate bed | 4.42 Fractions |
Primary
Maximum Tolerated Dose (MTD) of Radiation Dose to Prostate Bed and Dose to Tumor Reported in Gray (Gy)
Maximum tolerated dose (MTD) of image guided hypofractionated, focally dose escalated post-prostatectomy radiation is defined as the dose level at which no more than 1 of up to 6 participants experience dose limiting toxicity (DLT) during the DLT period, and the dose below that at which at least 2 (of ≤6) participants have DLT as a result of treatment. A DLT is defined as any of the following: Grade 3 rectal, small bowel, or urinary toxicity that does not resolve to Grade 2 or less within 4 days with appropriate medical management. Other grade 3 in-field toxicities attributable to radiation that does not resolve to Grade 2 or less within 4 days with appropriate medical management. And delays of more than one week in completing radiation treatment due to toxicity.
Time frame: 3 weeks after radiation
Population: 12/30 expansion group participants (6 in Recurrent Tumor Visible: Level 3 Cohort 1, and Recurrent Tumor NOT Visible: Level 3 Cohort 2) were not assessed for MTD and included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants With Recurrent Tumor Visible | Maximum Tolerated Dose (MTD) of Radiation Dose to Prostate Bed and Dose to Tumor Reported in Gray (Gy) | Dose to prostate bed | 36.4 Gray (Gy) |
| All Participants With Recurrent Tumor Visible | Maximum Tolerated Dose (MTD) of Radiation Dose to Prostate Bed and Dose to Tumor Reported in Gray (Gy) | Dose to tumor | 47.1 Gray (Gy) |
| All Participants With Recurrent Tumor NOT Visible | Maximum Tolerated Dose (MTD) of Radiation Dose to Prostate Bed and Dose to Tumor Reported in Gray (Gy) | Dose to prostate bed | 44.2 Gray (Gy) |
Secondary
American Urologic Association Symptom Index Score (AUA-SI)
The AUA-SI is used to measure radiation morbidity and to make treatment decisions.
Time frame: 2 years after treatment
Secondary
Biochemical Progression Free Survival (bPFS)
bPFS is defined as the duration of time from start of treatment to time of prostate-specific antigen (PSA) progression or death, whichever occurs first. PSA progression (also known as biochemical failure) is defined based on elevation of PSA beyond 0.1 ng/dL. Kaplan-Meier survival analysis and effects of clinical variables on bPFS will be assessed by the Cox proportional hazards model.
Time frame: 1 and 2 years after treatment
Secondary
Decision Regret Scale (DRS)
The DRS is a 5-item scale measuring distress or remorse after a health case decision. The score correlated with satisfaction with the decision (r=-0.40 to -0.60), decisional conflict (r=0.31 to 0.52), and overall rated quality of life (r=-0.25 to -0.27).
Time frame: 2 years after treatment
Secondary
Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research
Grade 2-5 serious and/or non-serious adverse events attributable to protocol treatment. A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. Grade 2 is moderate. Grade 3 is serious. Grade 4 is life-threatening. And Grade 5 is death related to adverse event.
Time frame: 3 weeks after radiation
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants With Recurrent Tumor Visible | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Unlikely Related Testicular pain | 0 adverse events |
| All Participants With Recurrent Tumor Visible | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Probably Related Urinary urgency | 0 adverse events |
| All Participants With Recurrent Tumor Visible | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Probably Related Hemorrhoids | 0 adverse events |
| All Participants With Recurrent Tumor Visible | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2-5 Serious | 0 adverse events |
| All Participants With Recurrent Tumor Visible | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Probably Related Diarrhea | 0 adverse events |
| All Participants With Recurrent Tumor Visible | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Probably Related Flatulence | 0 adverse events |
| All Participants With Recurrent Tumor Visible | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Definitely Related Flatulence | 0 adverse events |
| All Participants With Recurrent Tumor Visible | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Unlikely Related Testicular disorder | 0 adverse events |
| All Participants With Recurrent Tumor Visible | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 3 Probably Related Cystitis noninfective | 0 adverse events |
| All Participants With Recurrent Tumor Visible | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Possibly Related Urinary tract obstruction | 0 adverse events |
| All Participants With Recurrent Tumor Visible | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Unlikely Related - Skin and subcutaneous tissue disorders - Other, specify | 1 adverse events |
| All Participants With Recurrent Tumor Visible | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 3 Probably Related Urinary incontinence | 0 adverse events |
| All Participants With Recurrent Tumor Visible | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Possibly Related Flatulence | 0 adverse events |
| All Participants With Recurrent Tumor Visible | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Possibly Related Hemorrhoids | 0 adverse events |
| All Participants With Recurrent Tumor Visible | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 3 Probably Related Proctitis | 0 adverse events |
| All Participants With Recurrent Tumor Visible | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Possibly Related Diarrhea | 0 adverse events |
| All Participants With Recurrent Tumor Visible | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Probably Related Urinary incontinence | 0 adverse events |
| All Participants With Recurrent Tumor Visible | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Possibly Related Skin infection | 0 adverse events |
| All Participants With Recurrent Tumor Visible | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Definitely Related Proctitis | 0 adverse events |
| All Participants With Recurrent Tumor Visible | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Probably Related Rectal hemorrhage | 0 adverse events |
| All Participants With Recurrent Tumor Visible | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Probably Related Urinary frequency | 0 adverse events |
| All Participants With Recurrent Tumor Visible | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Probably Related - Urinary urgency | 1 adverse events |
| All Participants With Recurrent Tumor Visible | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Unlikely Related Hemorrhoids | 0 adverse events |
| All Participants With Recurrent Tumor Visible | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Probably Related Cystitis noninfective | 0 adverse events |
| All Participants With Recurrent Tumor Visible | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Probably Related Proctitis | 0 adverse events |
| All Participants With Recurrent Tumor NOT Visible | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Possibly Related Flatulence | 0 adverse events |
| All Participants With Recurrent Tumor NOT Visible | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Definitely Related Proctitis | 0 adverse events |
| All Participants With Recurrent Tumor NOT Visible | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Probably Related Urinary frequency | 0 adverse events |
| All Participants With Recurrent Tumor NOT Visible | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Possibly Related Urinary tract obstruction | 1 adverse events |
| All Participants With Recurrent Tumor NOT Visible | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 3 Probably Related Urinary incontinence | 1 adverse events |
| All Participants With Recurrent Tumor NOT Visible | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Probably Related Rectal hemorrhage | 0 adverse events |
| All Participants With Recurrent Tumor NOT Visible | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Unlikely Related Testicular disorder | 0 adverse events |
| All Participants With Recurrent Tumor NOT Visible | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Unlikely Related - Skin and subcutaneous tissue disorders - Other, specify | 0 adverse events |
| All Participants With Recurrent Tumor NOT Visible | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 3 Probably Related Proctitis | 0 adverse events |
| All Participants With Recurrent Tumor NOT Visible | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Possibly Related Hemorrhoids | 0 adverse events |
| All Participants With Recurrent Tumor NOT Visible | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Probably Related Cystitis noninfective | 0 adverse events |
| All Participants With Recurrent Tumor NOT Visible | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Possibly Related Diarrhea | 0 adverse events |
| All Participants With Recurrent Tumor NOT Visible | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Probably Related Hemorrhoids | 1 adverse events |
| All Participants With Recurrent Tumor NOT Visible | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Probably Related Urinary urgency | 1 adverse events |
| All Participants With Recurrent Tumor NOT Visible | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Probably Related Urinary incontinence | 0 adverse events |
| All Participants With Recurrent Tumor NOT Visible | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Probably Related Proctitis | 2 adverse events |
| All Participants With Recurrent Tumor NOT Visible | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Probably Related - Urinary urgency | 0 adverse events |
| All Participants With Recurrent Tumor NOT Visible | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Probably Related Diarrhea | 0 adverse events |
| All Participants With Recurrent Tumor NOT Visible | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2-5 Serious | 0 adverse events |
| All Participants With Recurrent Tumor NOT Visible | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Probably Related Flatulence | 0 adverse events |
| All Participants With Recurrent Tumor NOT Visible | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Possibly Related Skin infection | 0 adverse events |
| All Participants With Recurrent Tumor NOT Visible | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Definitely Related Flatulence | 0 adverse events |
| All Participants With Recurrent Tumor NOT Visible | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Unlikely Related Hemorrhoids | 0 adverse events |
| All Participants With Recurrent Tumor NOT Visible | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Unlikely Related Testicular pain | 0 adverse events |
| All Participants With Recurrent Tumor NOT Visible | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 3 Probably Related Cystitis noninfective | 0 adverse events |
| LEVEL 3/COHORT 1: Recurrent Tumor Visible; Prostate Bed With Integrated Boost - 10 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Possibly Related Diarrhea | 0 adverse events |
| LEVEL 3/COHORT 1: Recurrent Tumor Visible; Prostate Bed With Integrated Boost - 10 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Unlikely Related Testicular disorder | 0 adverse events |
| LEVEL 3/COHORT 1: Recurrent Tumor Visible; Prostate Bed With Integrated Boost - 10 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Probably Related Hemorrhoids | 1 adverse events |
| LEVEL 3/COHORT 1: Recurrent Tumor Visible; Prostate Bed With Integrated Boost - 10 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Probably Related Urinary frequency | 1 adverse events |
| LEVEL 3/COHORT 1: Recurrent Tumor Visible; Prostate Bed With Integrated Boost - 10 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 3 Probably Related Urinary incontinence | 0 adverse events |
| LEVEL 3/COHORT 1: Recurrent Tumor Visible; Prostate Bed With Integrated Boost - 10 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 3 Probably Related Cystitis noninfective | 0 adverse events |
| LEVEL 3/COHORT 1: Recurrent Tumor Visible; Prostate Bed With Integrated Boost - 10 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2-5 Serious | 0 adverse events |
| LEVEL 3/COHORT 1: Recurrent Tumor Visible; Prostate Bed With Integrated Boost - 10 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Possibly Related Urinary tract obstruction | 0 adverse events |
| LEVEL 3/COHORT 1: Recurrent Tumor Visible; Prostate Bed With Integrated Boost - 10 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Probably Related Proctitis | 3 adverse events |
| LEVEL 3/COHORT 1: Recurrent Tumor Visible; Prostate Bed With Integrated Boost - 10 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Probably Related Flatulence | 2 adverse events |
| LEVEL 3/COHORT 1: Recurrent Tumor Visible; Prostate Bed With Integrated Boost - 10 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Probably Related Urinary urgency | 0 adverse events |
| LEVEL 3/COHORT 1: Recurrent Tumor Visible; Prostate Bed With Integrated Boost - 10 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Probably Related Rectal hemorrhage | 1 adverse events |
| LEVEL 3/COHORT 1: Recurrent Tumor Visible; Prostate Bed With Integrated Boost - 10 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Unlikely Related Hemorrhoids | 0 adverse events |
| LEVEL 3/COHORT 1: Recurrent Tumor Visible; Prostate Bed With Integrated Boost - 10 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Possibly Related Flatulence | 1 adverse events |
| LEVEL 3/COHORT 1: Recurrent Tumor Visible; Prostate Bed With Integrated Boost - 10 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Probably Related - Urinary urgency | 0 adverse events |
| LEVEL 3/COHORT 1: Recurrent Tumor Visible; Prostate Bed With Integrated Boost - 10 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 3 Probably Related Proctitis | 1 adverse events |
| LEVEL 3/COHORT 1: Recurrent Tumor Visible; Prostate Bed With Integrated Boost - 10 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Unlikely Related Testicular pain | 0 adverse events |
| LEVEL 3/COHORT 1: Recurrent Tumor Visible; Prostate Bed With Integrated Boost - 10 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Definitely Related Flatulence | 1 adverse events |
| LEVEL 3/COHORT 1: Recurrent Tumor Visible; Prostate Bed With Integrated Boost - 10 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Definitely Related Proctitis | 3 adverse events |
| LEVEL 3/COHORT 1: Recurrent Tumor Visible; Prostate Bed With Integrated Boost - 10 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Possibly Related Hemorrhoids | 0 adverse events |
| LEVEL 3/COHORT 1: Recurrent Tumor Visible; Prostate Bed With Integrated Boost - 10 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Unlikely Related - Skin and subcutaneous tissue disorders - Other, specify | 0 adverse events |
| LEVEL 3/COHORT 1: Recurrent Tumor Visible; Prostate Bed With Integrated Boost - 10 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Possibly Related Skin infection | 0 adverse events |
| LEVEL 3/COHORT 1: Recurrent Tumor Visible; Prostate Bed With Integrated Boost - 10 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Probably Related Urinary incontinence | 0 adverse events |
| LEVEL 3/COHORT 1: Recurrent Tumor Visible; Prostate Bed With Integrated Boost - 10 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Probably Related Cystitis noninfective | 0 adverse events |
| LEVEL 3/COHORT 1: Recurrent Tumor Visible; Prostate Bed With Integrated Boost - 10 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Probably Related Diarrhea | 1 adverse events |
| LEVEL 1/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 20 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Probably Related Flatulence | 0 adverse events |
| LEVEL 1/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 20 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2-5 Serious | 0 adverse events |
| LEVEL 1/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 20 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Unlikely Related - Skin and subcutaneous tissue disorders - Other, specify | 0 adverse events |
| LEVEL 1/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 20 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Unlikely Related Hemorrhoids | 0 adverse events |
| LEVEL 1/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 20 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Unlikely Related Testicular pain | 0 adverse events |
| LEVEL 1/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 20 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Unlikely Related Testicular disorder | 0 adverse events |
| LEVEL 1/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 20 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Possibly Related Urinary tract obstruction | 0 adverse events |
| LEVEL 1/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 20 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Possibly Related Flatulence | 0 adverse events |
| LEVEL 1/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 20 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Possibly Related Hemorrhoids | 0 adverse events |
| LEVEL 1/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 20 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Possibly Related Diarrhea | 1 adverse events |
| LEVEL 1/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 20 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Possibly Related Skin infection | 0 adverse events |
| LEVEL 1/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 20 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Probably Related Rectal hemorrhage | 0 adverse events |
| LEVEL 1/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 20 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Probably Related - Urinary urgency | 0 adverse events |
| LEVEL 1/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 20 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Probably Related Proctitis | 0 adverse events |
| LEVEL 1/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 20 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Probably Related Urinary urgency | 0 adverse events |
| LEVEL 1/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 20 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Probably Related Diarrhea | 0 adverse events |
| LEVEL 1/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 20 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Probably Related Hemorrhoids | 0 adverse events |
| LEVEL 1/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 20 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Probably Related Cystitis noninfective | 0 adverse events |
| LEVEL 1/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 20 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Probably Related Urinary frequency | 0 adverse events |
| LEVEL 1/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 20 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Probably Related Urinary incontinence | 1 adverse events |
| LEVEL 1/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 20 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 3 Probably Related Proctitis | 0 adverse events |
| LEVEL 1/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 20 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 3 Probably Related Urinary incontinence | 0 adverse events |
| LEVEL 1/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 20 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 3 Probably Related Cystitis noninfective | 0 adverse events |
| LEVEL 1/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 20 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Definitely Related Flatulence | 0 adverse events |
| LEVEL 1/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 20 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Definitely Related Proctitis | 0 adverse events |
| LEVEL 2/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 15 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Probably Related - Urinary urgency | 0 adverse events |
| LEVEL 2/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 15 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Probably Related Rectal hemorrhage | 0 adverse events |
| LEVEL 2/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 15 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Possibly Related Urinary tract obstruction | 0 adverse events |
| LEVEL 2/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 15 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Possibly Related Diarrhea | 0 adverse events |
| LEVEL 2/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 15 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2-5 Serious | 0 adverse events |
| LEVEL 2/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 15 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 3 Probably Related Urinary incontinence | 0 adverse events |
| LEVEL 2/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 15 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Definitely Related Flatulence | 0 adverse events |
| LEVEL 2/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 15 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Unlikely Related Testicular disorder | 0 adverse events |
| LEVEL 2/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 15 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Unlikely Related - Skin and subcutaneous tissue disorders - Other, specify | 0 adverse events |
| LEVEL 2/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 15 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Unlikely Related Testicular pain | 0 adverse events |
| LEVEL 2/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 15 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Probably Related Urinary incontinence | 0 adverse events |
| LEVEL 2/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 15 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 3 Probably Related Cystitis noninfective | 1 adverse events |
| LEVEL 2/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 15 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Possibly Related Skin infection | 0 adverse events |
| LEVEL 2/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 15 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Possibly Related Hemorrhoids | 0 adverse events |
| LEVEL 2/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 15 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Unlikely Related Hemorrhoids | 0 adverse events |
| LEVEL 2/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 15 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Probably Related Cystitis noninfective | 1 adverse events |
| LEVEL 2/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 15 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Possibly Related Flatulence | 0 adverse events |
| LEVEL 2/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 15 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Probably Related Diarrhea | 0 adverse events |
| LEVEL 2/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 15 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Probably Related Hemorrhoids | 0 adverse events |
| LEVEL 2/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 15 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Probably Related Flatulence | 0 adverse events |
| LEVEL 2/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 15 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Probably Related Urinary frequency | 0 adverse events |
| LEVEL 2/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 15 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Probably Related Urinary urgency | 1 adverse events |
| LEVEL 2/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 15 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 3 Probably Related Proctitis | 0 adverse events |
| LEVEL 2/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 15 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Probably Related Proctitis | 2 adverse events |
| LEVEL 2/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 15 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Definitely Related Proctitis | 0 adverse events |
| LEVEL 3/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 10 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Probably Related Urinary urgency | 0 adverse events |
| LEVEL 3/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 10 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Probably Related Hemorrhoids | 5 adverse events |
| LEVEL 3/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 10 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Probably Related - Urinary urgency | 1 adverse events |
| LEVEL 3/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 10 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Probably Related Rectal hemorrhage | 0 adverse events |
| LEVEL 3/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 10 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Probably Related Cystitis noninfective | 1 adverse events |
| LEVEL 3/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 10 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Possibly Related Skin infection | 1 adverse events |
| LEVEL 3/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 10 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Definitely Related Flatulence | 0 adverse events |
| LEVEL 3/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 10 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Probably Related Urinary frequency | 0 adverse events |
| LEVEL 3/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 10 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Possibly Related Diarrhea | 1 adverse events |
| LEVEL 3/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 10 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Possibly Related Hemorrhoids | 2 adverse events |
| LEVEL 3/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 10 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Probably Related Urinary incontinence | 0 adverse events |
| LEVEL 3/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 10 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Possibly Related Flatulence | 0 adverse events |
| LEVEL 3/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 10 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2-5 Serious | 0 adverse events |
| LEVEL 3/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 10 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 3 Probably Related Proctitis | 0 adverse events |
| LEVEL 3/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 10 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Possibly Related Urinary tract obstruction | 0 adverse events |
| LEVEL 3/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 10 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Unlikely Related Testicular disorder | 1 adverse events |
| LEVEL 3/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 10 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 3 Probably Related Urinary incontinence | 0 adverse events |
| LEVEL 3/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 10 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Unlikely Related Testicular pain | 1 adverse events |
| LEVEL 3/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 10 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Definitely Related Proctitis | 4 adverse events |
| LEVEL 3/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 10 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 3 Probably Related Cystitis noninfective | 0 adverse events |
| LEVEL 3/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 10 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Unlikely Related Hemorrhoids | 1 adverse events |
| LEVEL 3/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 10 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Unlikely Related - Skin and subcutaneous tissue disorders - Other, specify | 0 adverse events |
| LEVEL 3/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 10 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Probably Related Diarrhea | 0 adverse events |
| LEVEL 3/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 10 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Probably Related Flatulence | 0 adverse events |
| LEVEL 3/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 10 Fractions | Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research | Grade 2 Probably Related Proctitis | 6 adverse events |
Secondary
Patient-Reported Outcomes Measurement Information System (PROMIS) - Anxiety Short Form (SF) 4a:
Participants complete a form and rate anxiety such as fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness), and somatic symptoms related to arousal (racing heart, dizziness).
Time frame: 2 years after treatment
Secondary
Patient-Reported Outcomes Measurement Information System (PROMIS) - Depression Short Form (SF) 4a:
Participants complete a form to assess negative mood (i.e., sadness, guilt), views of self (i.e., self-criticism, worthlessness) social cognition (loneliness, interpersonal alienation), decreased positive effect, and decreased engagement (loss of interest, meaning, and purpose) and are scored using item-level calibrations.
Time frame: 2 years after treatment
Secondary
Patient-Reported Outcomes Measurement Information System (PROMIS) - Psychosocial Impact Positive Short Form (SF) 4a
Participants complete a form to assess positive psychosocial (emotional and social) outcomes of illness.
Time frame: 2 years after treatment
Secondary
Proportion of Participants That Have Improvement in Quality of Life After Treatment
The quality-of-life scores will be summarized at baseline and for each visit. Linear mixed effects model will be used to model quality of life scores at baseline and during and after treatment in which random intercept and random slope are used to account for participant-specific trajectory of quality-of-life scores.
Time frame: 1 and 2 years after treatment
Secondary
Sexual Health Inventory for Men (SHIM)
Participants completed a 6-question questionnaire to assess erectile dysfunction.
Time frame: 2 years after treatment
Other Pre-specified
Number of Participants With a Dose-limiting Toxicity (DLT)
A DLT is defined as any of the following: Grade 3 rectal, small bowel, or urinary toxicity that does not resolve to Grade 2 or less within 4 days with appropriate medical management. Other grade 3 in-field toxicities attributable to radiation that does not resolve to Grade 2 or less within 4 days with appropriate medical management. And delays of more than one week in completing radiation treatment due to toxicity.
Time frame: 3 weeks after radiation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Participants With Recurrent Tumor Visible | Number of Participants With a Dose-limiting Toxicity (DLT) | 0 Participants |
| All Participants With Recurrent Tumor NOT Visible | Number of Participants With a Dose-limiting Toxicity (DLT) | 0 Participants |
| LEVEL 3/COHORT 1: Recurrent Tumor Visible; Prostate Bed With Integrated Boost - 10 Fractions | Number of Participants With a Dose-limiting Toxicity (DLT) | 0 Participants |
| LEVEL 1/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 20 Fractions | Number of Participants With a Dose-limiting Toxicity (DLT) | 0 Participants |
| LEVEL 2/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 15 Fractions | Number of Participants With a Dose-limiting Toxicity (DLT) | 0 Participants |
| LEVEL 3/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 10 Fractions | Number of Participants With a Dose-limiting Toxicity (DLT) | 0 Participants |
Other Pre-specified
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)
Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Time frame: Date treatment consent signed to date off study, an average of 25 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Participants With Recurrent Tumor Visible | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) | 3 Participants |
| All Participants With Recurrent Tumor NOT Visible | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) | 3 Participants |
| LEVEL 3/COHORT 1: Recurrent Tumor Visible; Prostate Bed With Integrated Boost - 10 Fractions | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) | 8 Participants |
| LEVEL 1/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 20 Fractions | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) | 3 Participants |
| LEVEL 2/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 15 Fractions | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) | 3 Participants |
| LEVEL 3/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 10 Fractions | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) | 9 Participants |