Prostate Adenocarcinoma, Prostate Cancer
Conditions
Brief summary
The hypotheses of this study are: 1. Delivery of single fraction Lattice Extreme Ablative Dose (LEAD) radiotherapy (RT) to the dominant tumor lesion(s) in the prostate as identified by multiparametric functional Magnetic Resonance Imaging is safe and feasible when given prior to standard prostate radiotherapy. 2. Biomarker expression levels differ in the functional MRI identified suspicious tumor regions and unsuspicious tumor regions. The investigators hypothesize that a significant source of variation in biomarker levels is due to tumor heterogeneity and that it is molecular abnormalities in the dominant tumor areas that are angiogenic and determine outcome.
Interventions
RADIATIONLattice Extreme Ablative Dose Radiation Therapy
12 - 14 Gy dose pipes in 1 fraction to the multiparametric MRI defined gross tumor volumes (GTV) on Day 1.
RADIATIONStandard IMRT
76 Gy in 38 fractions (2 Gy daily) of Standard Intensity-modulated radiation therapy (IMRT) starting on Day 2 for 7.5 weeks.
Sponsors
National Cancer Institute (NCI)
University of Miami
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
35 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Biopsy confirmed adenocarcinoma of the prostate. 2. T1-T3a disease based on digital rectal exam (DRE). * T3a disease based on MRI is acceptable (no evidence of frank (clear cut) seminal vesicle (SV) involvement or invasion of bladder or rectum). 3. Gleason score 6-10. 4. Patients with Gleason score ≥8 must be offered long term androgen deprivation therapy (ADT) and refuse such treatment because only 4-6 months (+/- 2 months) (short term ADT) is permitted (not required) on this protocol. The ADT is recommended to begin after fiducial marker placement; however, ADT is permitted to have been started up to two months prior to the signing of consent. All patients in this protocol may (not required) be treated with 4-6 months (+/- 2 months) of ADT, at the discretion of the treating physician. * Gleason ≥ 8 must have \< 40% of the tissue involved with Gleason 8 in the biopsy specimen. 5. Prostate-specific antigen (PSA) ≤ 30 ng/mL within 3 months of enrollment. If PSA was above 30 and dropped to ≤ 30 with antibiotics, this is acceptable for enrollment. 6. No previous pelvic radiotherapy. 7. No previous history of radical/total prostatectomy (suprapubic prostatectomy is acceptable). 8. 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. 9. Identifiable multiparametric-MRI tumor lesion or lesions, that total in volume \< 33% of the prostate * Multiparametric MRI of prostate and pelvis is required prior to protocol consideration. * If contrast not given, the point dose on the apparent diffusion coefficient (ADC) map should be \< 1000. 10. Ability to understand and the willingness to sign a written informed consent document. 11. Zubrod performance status \< 2. 12. Willingness to fill out quality of life forms. 13. Bone scan negative if PSA \> 15 ng/mL or Gleason ≥ 8 disease. A questionable bone scan is acceptable if other imaging tests are negative for metastasis. 14. 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), and 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. 15. Serum liver function tests (LFT) are taken within 3 months of enrollment. 16. Complete blood counts are taken within 3 months of enrollment. 17. Age ≥ 35 and ≤ 85 years.
Exclusion criteria
1. \> T3a disease on digital rectal exam or \>T3a disease clearly identified by MRI. 2. Gleason score \< 6. 3. ≥ 40% Gleason 8-10 tumor, over the total tissue including other tumor and normal tissue. For example: (Gleason 8-10 tumor length/other biopsy tissue length)\*100 = ≥ 40%. 4. Androgen deprivation therapy longer than 8 months. Androgen deprivation timing is for the Luteinizing hormone-releasing hormone (LHRH) agonist portion only and not when anti-androgen is started beforehand with the purpose of counteracting the surge in testosterone from the LHRH agonist - PSA \> 30 ng/mL within 3 months of enrollment. 5. PSA \> 30 ng/mL within 3 months of enrollment 6. Unable to obtain a 1.5T or 3.0T multiparametric MRI of the pelvis and prostate with contrast. 7. Unidentifiable multiparametric MRI tumor lesion. 8. Identifiable multiparametric-MRI tumor lesions, that total in volume ≥ 33% of the prostate. 9. Previous pelvic radiotherapy. 10. Previous history of radical prostatectomy. 11. 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. 12. Zubrod performance status ≥ 2. 13. Inability to understand or unwilling to sign a written informed consent document 14. Unwilling to fill out quality of life/psychosocial forms. 15. Bone scan is positive and other imaging tests confirm a suspicion of metastasis from prostate cancer. 16. Serum testosterone is not within 40% of normal assay limits taken within 4 months of enrollment (only applicable to patients not started on ADT prior to signing consent). 17. Serum liver function tests (LFTs) are not taken within 3 months of enrollment. 18. Complete blood counts are not taken within 3 months of enrollment. 19. Age \< 35 and \> 85 years.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Enrolled Patients for Whom LEAD RT Dose Can be Successfully Administered Following MRI-guided Planning. | Up to 8 weeks | The percentage of enrolled patients for whom LEAD RT dose can be successfully administered following MRI-guided planning. |
| Number of Study Participants Experiencing Treatment-Related Toxicity | Up to 8.5 weeks | Toxicity are any Grade 2 or higher treatment-related adverse events as assessed by treating physician using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.0. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HrQoL as Assessed by EPIC-SF12 Questionnaire | At Baseline (Prior to RT), at 8 weeks (Last week of RT), At 6 weeks post RT, At 3 months post RT, At 6 months post RT, At 9 months post RT, At 15 months post RT, At 27 months post RT, At 39 months post RT, At 51 months post RT, At 63 months post RT | 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. The questionnaire has 5 subscales (Urinary Function, Urinary Symptoms, Bowel Habits, Sexual Function and Hormonal Function). Each subscale has a total score ranging from 0-100, with higher scores representing better HRQOL. |
| HrQoL as Assessed by MAX-PC Questionnaire | At Baseline (Prior to RT), at 8 weeks (Last week of RT), At 6 weeks post RT, At 3 months post RT, At 6 months post RT, At 9 months post RT, At 15 months post RT, At 27 months post RT, At 39 months post RT, At 51 months post RT, At 63 months post RT | 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) from pre-treatment to post-treatment. 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. |
| Number of Participants With Remaining Tumor Cells in the Prostate Post Treatment | Up to 2.5 Years | The number of participants with positive tumor cells left in the prostate after LEAD RT as evaluated by prostate biopsy. |
| Rate of Participants That Achieve Failure-Free Survival (FFS) | Up to 6 years | The percentage of participants achieving FFS will be reported. Failure-free is defined as no documented evidence of biochemical and/or or clinical failure or death from any cause, whichever occur first. Biochemical failure is defined is a 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. |
| Percentage of Participants With Positive Prostate Biopsies After Completion of Treatment | From Baseline to 2.5 Years Post Completion of Study Therapy (Approximately 3 years) | Preliminary indication of efficacy of treatment will be reported as the percentage of participants with positive prostate biopsies after completion of treatment. |
| Overall Survival (OS) | Up to 6 years | Overall survival is defined as the elapsed time from study enrollment to death from any cause. For surviving patients, follow-up will be censored at the date of last contact. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| LEAD Radiation Therapy Participants in this group will receive the LEAD Radiation Therapy on Day 1 followed by 38 daily standard IMRT beginning Day 2.
Lattice Extreme Ablative Dose Radiation Therapy: 12 - 14 Gy dose pipes in 1 fraction to the multiparametric MRI defined gross tumor volumes (GTV) on Day 1.
Standard IMRT: 76 Gy in 38 fractions (2 Gy daily) of Standard Intensity-modulated radiation therapy (IMRT) starting on Day 2 for 7.5 weeks. | 25 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | LEAD Radiation Therapy |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 18 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants |
| Age, Continuous | 67 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 17 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 23 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 25 |
| other Total, other adverse events | 25 / 25 |
| serious Total, serious adverse events | 1 / 25 |
Outcome results
Primary
Number of Study Participants Experiencing Treatment-Related Toxicity
Toxicity are any Grade 2 or higher treatment-related adverse events as assessed by treating physician using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.0.
Time frame: Up to 8.5 weeks
Population: All 25 participants were evaluated up to 8.5 weeks.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LEAD Radiation Therapy | Number of Study Participants Experiencing Treatment-Related Toxicity | SAEs with Probable Relation to Study Treatment | 0 Participants |
| LEAD Radiation Therapy | Number of Study Participants Experiencing Treatment-Related Toxicity | Serious Adverse Events (SAEs) with Definite Relation to Study Treatment | 0 Participants |
| LEAD Radiation Therapy | Number of Study Participants Experiencing Treatment-Related Toxicity | SAEs with Possible Relation to Study Treatment | 1 Participants |
| LEAD Radiation Therapy | Number of Study Participants Experiencing Treatment-Related Toxicity | Adverse Events (AEs) with Definite Relation to Study Treatment | 9 Participants |
| LEAD Radiation Therapy | Number of Study Participants Experiencing Treatment-Related Toxicity | AEs with Probable Relation to Study Treatment | 10 Participants |
| LEAD Radiation Therapy | Number of Study Participants Experiencing Treatment-Related Toxicity | AEs with Possible Relation to Study Treatment | 5 Participants |
Primary
Percentage of Enrolled Patients for Whom LEAD RT Dose Can be Successfully Administered Following MRI-guided Planning.
The percentage of enrolled patients for whom LEAD RT dose can be successfully administered following MRI-guided planning.
Time frame: Up to 8 weeks
Population: All 25 enrolled participants completed the duration of study treatment (8 weeks).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LEAD Radiation Therapy | Percentage of Enrolled Patients for Whom LEAD RT Dose Can be Successfully Administered Following MRI-guided Planning. | 100 percentage of participants |
Secondary
HrQoL as Assessed by EPIC-SF12 Questionnaire
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. The questionnaire has 5 subscales (Urinary Function, Urinary Symptoms, Bowel Habits, Sexual Function and Hormonal Function). Each subscale has a total score ranging from 0-100, with higher scores representing better HRQOL.
Time frame: At Baseline (Prior to RT), at 8 weeks (Last week of RT), At 6 weeks post RT, At 3 months post RT, At 6 months post RT, At 9 months post RT, At 15 months post RT, At 27 months post RT, At 39 months post RT, At 51 months post RT, At 63 months post RT
Population: Not all participants were able to complete the questionnaires at different timepoints in the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LEAD Radiation Therapy | HrQoL as Assessed by EPIC-SF12 Questionnaire | Urinary Function: 39 Months Post-RT | 95.8 score on a scale | Standard Deviation 9.2 |
| LEAD Radiation Therapy | HrQoL as Assessed by EPIC-SF12 Questionnaire | Urinary Function: 51 Months Post-RT | 92.8 score on a scale | Standard Deviation 17 |
| LEAD Radiation Therapy | HrQoL as Assessed by EPIC-SF12 Questionnaire | Urinary Function: Prior to Radiation Therapy (RT) | 94.5 score on a scale | Standard Deviation 10.9 |
| LEAD Radiation Therapy | HrQoL as Assessed by EPIC-SF12 Questionnaire | Urinary Function: 8 Weeks (Last Week of RT) | 92.5 score on a scale | Standard Deviation 14.4 |
| LEAD Radiation Therapy | HrQoL as Assessed by EPIC-SF12 Questionnaire | Urinary Function: 6 Weeks Post-RT | 92.8 score on a scale | Standard Deviation 20 |
| LEAD Radiation Therapy | HrQoL as Assessed by EPIC-SF12 Questionnaire | Urinary Function: 3 Months Post-RT | 93.1 score on a scale | Standard Deviation 17.6 |
| LEAD Radiation Therapy | HrQoL as Assessed by EPIC-SF12 Questionnaire | Urinary Function: 9 Months Post-RT | 93.5 score on a scale | Standard Deviation 16.6 |
| LEAD Radiation Therapy | HrQoL as Assessed by EPIC-SF12 Questionnaire | Urinary Function: 15 Months Post-RT | 93.2 score on a scale | Standard Deviation 14.5 |
| LEAD Radiation Therapy | HrQoL as Assessed by EPIC-SF12 Questionnaire | Urinary Function: 27 Months Post-RT | 93.6 score on a scale | Standard Deviation 15.5 |
| LEAD Radiation Therapy | HrQoL as Assessed by EPIC-SF12 Questionnaire | Urinary Function: 63 Months Post-RT | 94.2 score on a scale | Standard Deviation 18.8 |
| LEAD Radiation Therapy | HrQoL as Assessed by EPIC-SF12 Questionnaire | Urinary Symptoms: Prior to RT | 88.5 score on a scale | Standard Deviation 13.9 |
| LEAD Radiation Therapy | HrQoL as Assessed by EPIC-SF12 Questionnaire | Urinary Symptoms: 8 Weeks (Last Week of RT) | 79.2 score on a scale | Standard Deviation 13 |
| LEAD Radiation Therapy | HrQoL as Assessed by EPIC-SF12 Questionnaire | Urinary Symptoms: 6 Weeks Post-RT | 85.7 score on a scale | Standard Deviation 11.9 |
| LEAD Radiation Therapy | HrQoL as Assessed by EPIC-SF12 Questionnaire | Urinary Symptoms: 3 Months Post-RT | 87.5 score on a scale | Standard Deviation 11.6 |
| LEAD Radiation Therapy | HrQoL as Assessed by EPIC-SF12 Questionnaire | Urinary Symptoms: 9 Months Post-RT | 85.1 score on a scale | Standard Deviation 17.9 |
| LEAD Radiation Therapy | HrQoL as Assessed by EPIC-SF12 Questionnaire | Urinary Symptoms: 15 Months Post-RT | 87.2 score on a scale | Standard Deviation 13.8 |
| LEAD Radiation Therapy | HrQoL as Assessed by EPIC-SF12 Questionnaire | Urinary Symptoms: 27 Months Post-RT | 91.4 score on a scale | Standard Deviation 7.3 |
| LEAD Radiation Therapy | HrQoL as Assessed by EPIC-SF12 Questionnaire | Urinary Symptoms: 39 Months Post-RT | 90.8 score on a scale | Standard Deviation 7.4 |
| LEAD Radiation Therapy | HrQoL as Assessed by EPIC-SF12 Questionnaire | Urinary Symptoms: 51 Months Post-RT | 91.2 score on a scale | Standard Deviation 13.6 |
| LEAD Radiation Therapy | HrQoL as Assessed by EPIC-SF12 Questionnaire | Urinary Symptoms: 63 Months Post-RT | 90.8 score on a scale | Standard Deviation 8.6 |
| LEAD Radiation Therapy | HrQoL as Assessed by EPIC-SF12 Questionnaire | Bowel Habits: Prior to RT | 98.5 score on a scale | Standard Deviation 4.5 |
| LEAD Radiation Therapy | HrQoL as Assessed by EPIC-SF12 Questionnaire | Bowel Habits: 8 Weeks (Last Weeks of RT) | 89.7 score on a scale | Standard Deviation 14.1 |
| LEAD Radiation Therapy | HrQoL as Assessed by EPIC-SF12 Questionnaire | Bowel Habits: 6 Weeks Post-RT | 95.3 score on a scale | Standard Deviation 8 |
| LEAD Radiation Therapy | HrQoL as Assessed by EPIC-SF12 Questionnaire | Bowel Habits: 3 Months Post-RT | 93.7 score on a scale | Standard Deviation 10 |
| LEAD Radiation Therapy | HrQoL as Assessed by EPIC-SF12 Questionnaire | Bowel Habits: 9 Months Post-RT | 95.1 score on a scale | Standard Deviation 8.3 |
| LEAD Radiation Therapy | HrQoL as Assessed by EPIC-SF12 Questionnaire | Bowel Habits: 15 Months Post-RT | 95.7 score on a scale | Standard Deviation 6.6 |
| LEAD Radiation Therapy | HrQoL as Assessed by EPIC-SF12 Questionnaire | Bowel Habits: 27 Months Post-RT | 93.3 score on a scale | Standard Deviation 9.6 |
| LEAD Radiation Therapy | HrQoL as Assessed by EPIC-SF12 Questionnaire | Bowel Habits: 39 Months Post-RT | 95.8 score on a scale | Standard Deviation 7.6 |
| LEAD Radiation Therapy | HrQoL as Assessed by EPIC-SF12 Questionnaire | Bowel Habits: 51 Months Post-RT | 91.7 score on a scale | Standard Deviation 13.3 |
| LEAD Radiation Therapy | HrQoL as Assessed by EPIC-SF12 Questionnaire | Bowel Habits: 63 Months Post-RT | 93.6 score on a scale | Standard Deviation 10.1 |
| LEAD Radiation Therapy | HrQoL as Assessed by EPIC-SF12 Questionnaire | Sexual Function: Prior to RT | 55.2 score on a scale | Standard Deviation 23.9 |
| LEAD Radiation Therapy | HrQoL as Assessed by EPIC-SF12 Questionnaire | Sexual Function: 8 Weeks (Last Week of RT) | 39.5 score on a scale | Standard Deviation 31.6 |
| LEAD Radiation Therapy | HrQoL as Assessed by EPIC-SF12 Questionnaire | Sexual Function: 6 Weeks Post-RT | 38.2 score on a scale | Standard Deviation 34.7 |
| LEAD Radiation Therapy | HrQoL as Assessed by EPIC-SF12 Questionnaire | Sexual Function: 3 Months Post-RT | 42.7 score on a scale | Standard Deviation 37.3 |
| LEAD Radiation Therapy | HrQoL as Assessed by EPIC-SF12 Questionnaire | Sexual Function: 9 Months Post-RT | 44.6 score on a scale | Standard Deviation 33 |
| LEAD Radiation Therapy | HrQoL as Assessed by EPIC-SF12 Questionnaire | Sexual Function: 15 Months Post-RT | 49.2 score on a scale | Standard Deviation 31.4 |
| LEAD Radiation Therapy | HrQoL as Assessed by EPIC-SF12 Questionnaire | Sexual Function: 27 Months Post-RT | 44.5 score on a scale | Standard Deviation 28.8 |
| LEAD Radiation Therapy | HrQoL as Assessed by EPIC-SF12 Questionnaire | Sexual Function: 39 Months Post-RT | 41.8 score on a scale | Standard Deviation 29.2 |
| LEAD Radiation Therapy | HrQoL as Assessed by EPIC-SF12 Questionnaire | Sexual Function: 51 Months Post-RT | 47.7 score on a scale | Standard Deviation 29 |
| LEAD Radiation Therapy | HrQoL as Assessed by EPIC-SF12 Questionnaire | Sexual Function: 63 Months Post-RT | 36.6 score on a scale | Standard Deviation 25.1 |
| LEAD Radiation Therapy | HrQoL as Assessed by EPIC-SF12 Questionnaire | Hormonal Function: Prior to RT | 88 score on a scale | Standard Deviation 15.1 |
| LEAD Radiation Therapy | HrQoL as Assessed by EPIC-SF12 Questionnaire | Hormonal Function: 8 Weeks (Last week of RT) | 86.2 score on a scale | Standard Deviation 15.1 |
| LEAD Radiation Therapy | HrQoL as Assessed by EPIC-SF12 Questionnaire | Hormonal Function: 6 Weeks Post-RT | 86.5 score on a scale | Standard Deviation 13.4 |
| LEAD Radiation Therapy | HrQoL as Assessed by EPIC-SF12 Questionnaire | Hormonal Function: 3 Months Post-RT | 85.4 score on a scale | Standard Deviation 17.1 |
| LEAD Radiation Therapy | HrQoL as Assessed by EPIC-SF12 Questionnaire | Hormonal Function: 9 Months Post-RT | 89.8 score on a scale | Standard Deviation 11.4 |
| LEAD Radiation Therapy | HrQoL as Assessed by EPIC-SF12 Questionnaire | Hormonal Function: 15 Months Post-RT | 92.8 score on a scale | Standard Deviation 9 |
| LEAD Radiation Therapy | HrQoL as Assessed by EPIC-SF12 Questionnaire | Hormonal Function: 27 Months Post-RT | 93.8 score on a scale | Standard Deviation 7.2 |
| LEAD Radiation Therapy | HrQoL as Assessed by EPIC-SF12 Questionnaire | Hormonal Function: 39 Months Post-RT | 91.9 score on a scale | Standard Deviation 10.3 |
| LEAD Radiation Therapy | HrQoL as Assessed by EPIC-SF12 Questionnaire | Hormonal Function: 51 Months Post-RT | 87.9 score on a scale | Standard Deviation 17.1 |
| LEAD Radiation Therapy | HrQoL as Assessed by EPIC-SF12 Questionnaire | Hormonal Function: 63 Months Post-RT | 91.5 score on a scale | Standard Deviation 10 |
Secondary
HrQoL as Assessed by MAX-PC Questionnaire
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) from pre-treatment to post-treatment. 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 (Prior to RT), at 8 weeks (Last week of RT), At 6 weeks post RT, At 3 months post RT, At 6 months post RT, At 9 months post RT, At 15 months post RT, At 27 months post RT, At 39 months post RT, At 51 months post RT, At 63 months post RT
Population: Not all participants were able to complete the questionnaires at different timepoints in the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LEAD Radiation Therapy | HrQoL as Assessed by MAX-PC Questionnaire | Prior to Radiation Therapy (RT) | 13.7 score on a scale | Standard Deviation 6.3 |
| LEAD Radiation Therapy | HrQoL as Assessed by MAX-PC Questionnaire | 8 Weeks (Last Week of RT) | 15.1 score on a scale | Standard Deviation 7.2 |
| LEAD Radiation Therapy | HrQoL as Assessed by MAX-PC Questionnaire | 6 Weeks Post-RT | 13.3 score on a scale | Standard Deviation 7.5 |
| LEAD Radiation Therapy | HrQoL as Assessed by MAX-PC Questionnaire | 3 Months Post-RT | 11.7 score on a scale | Standard Deviation 7.5 |
| LEAD Radiation Therapy | HrQoL as Assessed by MAX-PC Questionnaire | 9 Months Post-RT | 12.6 score on a scale | Standard Deviation 7.5 |
| LEAD Radiation Therapy | HrQoL as Assessed by MAX-PC Questionnaire | 15 Months Post-RT | 10 score on a scale | Standard Deviation 6.9 |
| LEAD Radiation Therapy | HrQoL as Assessed by MAX-PC Questionnaire | 27 Months Post-RT | 12.2 score on a scale | Standard Deviation 6.1 |
| LEAD Radiation Therapy | HrQoL as Assessed by MAX-PC Questionnaire | 39 Months Post-RT | 12.3 score on a scale | Standard Deviation 7.2 |
| LEAD Radiation Therapy | HrQoL as Assessed by MAX-PC Questionnaire | 51 Months Post-RT | 11.2 score on a scale | Standard Deviation 9.1 |
| LEAD Radiation Therapy | HrQoL as Assessed by MAX-PC Questionnaire | 63 Months Post-RT | 12.9 score on a scale | Standard Deviation 6.2 |
Secondary
Number of Participants With Remaining Tumor Cells in the Prostate Post Treatment
The number of participants with positive tumor cells left in the prostate after LEAD RT as evaluated by prostate biopsy.
Time frame: Up to 2.5 Years
Population: Endpoint biopsy was collected only on 12 of 25 participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| LEAD Radiation Therapy | Number of Participants With Remaining Tumor Cells in the Prostate Post Treatment | 1 Participants |
Secondary
Overall Survival (OS)
Overall survival is defined as the elapsed time from study enrollment to death from any cause. For surviving patients, follow-up will be censored at the date of last contact.
Time frame: Up to 6 years
Population: Timeframe allows for study visit windows.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| LEAD Radiation Therapy | Overall Survival (OS) | 66 months |
Secondary
Percentage of Participants With Positive Prostate Biopsies After Completion of Treatment
Preliminary indication of efficacy of treatment will be reported as the percentage of participants with positive prostate biopsies after completion of treatment.
Time frame: From Baseline to 2.5 Years Post Completion of Study Therapy (Approximately 3 years)
Population: One participant was lost to follow-up at the follow-up period post-completion of treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LEAD Radiation Therapy | Percentage of Participants With Positive Prostate Biopsies After Completion of Treatment | 4 percentage of participants |
Secondary
Rate of Participants That Achieve Failure-Free Survival (FFS)
The percentage of participants achieving FFS will be reported. Failure-free is defined as no documented evidence of biochemical and/or or clinical failure or death from any cause, whichever occur first. Biochemical failure is defined is a 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: One participant was lost to follow-up at the follow-up period post-completion of treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LEAD Radiation Therapy | Rate of Participants That Achieve Failure-Free Survival (FFS) | 90.5 percentage of participants |