An interventional study of Lattice Extreme Ablative Dose Radiation Therapy and Standard IMRT in Prostate Cancer and Prostate Adenocarcinoma, sponsored by University of Miami. Completed at 1 site in United States. Open to male participants aged 35 Years to 85 Years. Per ClinicalTrials.gov, last updated 2021-07-13.
Sponsored by University of Miami · Not applicable, Interventional, and Treatment
The hypotheses of this study are:
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 25 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →University of Miami is the lead sponsor of 820 studies on the registry; 161 are open to participants now.
Of its 111 completed or terminated interventional studies of FDA-regulated products, 93 (84%) have results posted.
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T1-T3a disease based on digital rectal exam (DRE).
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.
Identifiable multiparametric-MRI tumor lesion or lesions, that total in volume \< 33% of the prostate
Exclusion Criteria:
Participants in this group will receive the LEAD Radiation Therapy on Day 1 followed by 38 daily standard IMRT beginning Day 2.
Radiation: Lattice Extreme Ablative Dose Radiation Therapy · Radiation: Standard IMRT
12 - 14 Gy dose pipes in 1 fraction to the multiparametric MRI defined gross tumor volumes (GTV) on Day 1.
Also known as: LEAD RT
76 Gy in 38 fractions (2 Gy daily) of Standard Intensity-modulated radiation therapy (IMRT) starting on Day 2 for 7.5 weeks.
Also known as: IMRT
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
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
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
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)
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
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
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
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
| Milestone | LEAD Radiation Therapy |
|---|---|
| Started | 25 |
| Completed | 24 |
| Not completed | 1 |
| Withdrew: Lost to follow-up | 1 |
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.
| Participants | LEAD Radiation Therapy |
|---|---|
| Serious Adverse Events (SAEs) with Definite Relation to Study Treatment | 0 |
| SAEs with Probable Relation to Study Treatment | 0 |
| SAEs with Possible Relation to Study Treatment | 1 |
| Adverse Events (AEs) with Definite Relation to Study Treatment | 9 |
| AEs with Probable Relation to Study Treatment | 10 |
| AEs with Possible Relation to Study Treatment | 5 |
The percentage of enrolled patients for whom LEAD RT dose can be successfully administered following MRI-guided planning.
| percentage of participants | LEAD Radiation Therapy |
|---|---|
| Percentage of Enrolled Patients for Whom LEAD RT Dose Can be Successfully Administered Following MRI-guided Planning. | 100 |
The number of participants with positive tumor cells left in the prostate after LEAD RT as evaluated by prostate biopsy.
| Participants | LEAD Radiation Therapy |
|---|---|
| Number of Participants With Remaining Tumor Cells in the Prostate Post Treatment | 1 |
Preliminary indication of efficacy of treatment will be reported as the percentage of participants with positive prostate biopsies after completion of treatment.
| percentage of participants | LEAD Radiation Therapy |
|---|---|
| Percentage of Participants With Positive Prostate Biopsies After Completion of Treatment | 4 (0.7 to 19.5) |
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 | LEAD Radiation Therapy |
|---|---|
| Rate of Participants That Achieve Failure-Free Survival (FFS) | 90.5 |
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.
| months | LEAD Radiation Therapy |
|---|---|
| Overall Survival (OS) | 66 (20.7 to 70.6) |
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.
| score on a scale | LEAD Radiation Therapy |
|---|---|
| Urinary Function: Prior to Radiation Therapy (RT) | 94.5 ± 10.9 |
| Urinary Function: 8 Weeks (Last Week of RT) | 92.5 ± 14.4 |
| Urinary Function: 6 Weeks Post-RT | 92.8 ± 20 |
| Urinary Function: 3 Months Post-RT | 93.1 ± 17.6 |
| Urinary Function: 9 Months Post-RT | 93.5 ± 16.6 |
| Urinary Function: 15 Months Post-RT | 93.2 ± 14.5 |
| Urinary Function: 27 Months Post-RT | 93.6 ± 15.5 |
| Urinary Function: 39 Months Post-RT | 95.8 ± 9.2 |
| Urinary Function: 51 Months Post-RT | 92.8 ± 17 |
| Urinary Function: 63 Months Post-RT | 94.2 ± 18.8 |
| Urinary Symptoms: Prior to RT | 88.5 ± 13.9 |
| Urinary Symptoms: 8 Weeks (Last Week of RT) | 79.2 ± 13 |
| Urinary Symptoms: 6 Weeks Post-RT | 85.7 ± 11.9 |
| Urinary Symptoms: 3 Months Post-RT | 87.5 ± 11.6 |
| Urinary Symptoms: 9 Months Post-RT | 85.1 ± 17.9 |
| Urinary Symptoms: 15 Months Post-RT | 87.2 ± 13.8 |
| Urinary Symptoms: 27 Months Post-RT | 91.4 ± 7.3 |
| Urinary Symptoms: 39 Months Post-RT | 90.8 ± 7.4 |
| Urinary Symptoms: 51 Months Post-RT | 91.2 ± 13.6 |
| Urinary Symptoms: 63 Months Post-RT | 90.8 ± 8.6 |
| Bowel Habits: Prior to RT | 98.5 ± 4.5 |
| Bowel Habits: 8 Weeks (Last Weeks of RT) | 89.7 ± 14.1 |
| Bowel Habits: 6 Weeks Post-RT | 95.3 ± 8 |
| Bowel Habits: 3 Months Post-RT | 93.7 ± 10 |
| Bowel Habits: 9 Months Post-RT | 95.1 ± 8.3 |
| Bowel Habits: 15 Months Post-RT | 95.7 ± 6.6 |
| Bowel Habits: 27 Months Post-RT | 93.3 ± 9.6 |
| Bowel Habits: 39 Months Post-RT | 95.8 ± 7.6 |
| Bowel Habits: 51 Months Post-RT | 91.7 ± 13.3 |
| Bowel Habits: 63 Months Post-RT | 93.6 ± 10.1 |
| Sexual Function: Prior to RT | 55.2 ± 23.9 |
| Sexual Function: 8 Weeks (Last Week of RT) | 39.5 ± 31.6 |
| Sexual Function: 6 Weeks Post-RT | 38.2 ± 34.7 |
| Sexual Function: 3 Months Post-RT | 42.7 ± 37.3 |
| Sexual Function: 9 Months Post-RT | 44.6 ± 33 |
| Sexual Function: 15 Months Post-RT | 49.2 ± 31.4 |
| Sexual Function: 27 Months Post-RT | 44.5 ± 28.8 |
| Sexual Function: 39 Months Post-RT | 41.8 ± 29.2 |
| Sexual Function: 51 Months Post-RT | 47.7 ± 29 |
| Sexual Function: 63 Months Post-RT | 36.6 ± 25.1 |
| Hormonal Function: Prior to RT | 88 ± 15.1 |
| Hormonal Function: 8 Weeks (Last week of RT) | 86.2 ± 15.1 |
| Hormonal Function: 6 Weeks Post-RT | 86.5 ± 13.4 |
| Hormonal Function: 3 Months Post-RT | 85.4 ± 17.1 |
| Hormonal Function: 9 Months Post-RT | 89.8 ± 11.4 |
| Hormonal Function: 15 Months Post-RT | 92.8 ± 9 |
| Hormonal Function: 27 Months Post-RT | 93.8 ± 7.2 |
| Hormonal Function: 39 Months Post-RT | 91.9 ± 10.3 |
| Hormonal Function: 51 Months Post-RT | 87.9 ± 17.1 |
| Hormonal Function: 63 Months Post-RT | 91.5 ± 10 |
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.
| score on a scale | LEAD Radiation Therapy |
|---|---|
| Prior to Radiation Therapy (RT) | 13.7 ± 6.3 |
| 8 Weeks (Last Week of RT) | 15.1 ± 7.2 |
| 6 Weeks Post-RT | 13.3 ± 7.5 |
| 3 Months Post-RT | 11.7 ± 7.5 |
| 9 Months Post-RT | 12.6 ± 7.5 |
| 15 Months Post-RT | 10 ± 6.9 |
| 27 Months Post-RT | 12.2 ± 6.1 |
| 39 Months Post-RT | 12.3 ± 7.2 |
| 51 Months Post-RT | 11.2 ± 9.1 |
| 63 Months Post-RT | 12.9 ± 6.2 |
Collected over Up to 6 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| LEAD Radiation Therapy | 1/25 (4%) | 1/25 (4%) | 25/25 (100%) |
| Event | LEAD Radiation Therapy |
|---|---|
| Urinary Tract InfectionRenal and urinary disorders | 1/25 |
| Event | LEAD Radiation Therapy |
|---|---|
| Urinary frequencyRenal and urinary disorders | 19/25 |
| Urinary urgencyRenal and urinary disorders | 16/25 |
| Cystitis noninfectiveRenal and urinary disorders | 13/25 |
| FatigueGeneral disorders | 10/25 |
| DiarrheaGastrointestinal disorders | 9/25 |
| Urinary retentionRenal and urinary disorders | 8/25 |
| Urinary obstructive symptoms, urinary hesitancy, increased frequency of bowel movement (no diarrhea)Renal and urinary disorders | 7/25 |
| Rectal painGastrointestinal disorders | 4/25 |
| Urinary incontinenceRenal and urinary disorders | 4/25 |
| Urinary tract obstructionRenal and urinary disorders | 4/25 |
| Age, Categorical(Participants) | LEAD Radiation Therapy |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 7 |
| >=65 years | 18 |
| Age, Continuous(years) | LEAD Radiation Therapy |
|---|---|
| Median | 67 (44 to 85) |
| Sex: Female, Male(Participants) | LEAD Radiation Therapy |
|---|---|
| Female | 0 |
| Male | 25 |
| Ethnicity (NIH/OMB)(Participants) | LEAD Radiation Therapy |
|---|---|
| Hispanic or Latino | 17 |
| Not Hispanic or Latino | 8 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | LEAD Radiation Therapy |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 23 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
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