MRI-Guided Lattice Extreme Ablative Dose Radiotherapy For Prostate Cancer (LEAD)
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|ClinicalTrials.gov Identifier: NCT01411319|
Recruitment Status : Completed
First Posted : August 8, 2011
Results First Posted : June 16, 2021
Last Update Posted : July 13, 2021
The hypotheses of this study are:
- 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.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer Prostate Adenocarcinoma||Radiation: Lattice Extreme Ablative Dose Radiation Therapy Radiation: Standard IMRT||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Trial of MRI-Guided Lattice Extreme Ablative Dose Radiotherapy For Prostate Cancer|
|Actual Study Start Date :||December 27, 2011|
|Actual Primary Completion Date :||December 31, 2014|
|Actual Study Completion Date :||March 2, 2020|
Experimental: 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.
Radiation: 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.
Other Name: LEAD RT
Radiation: 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.
Other Name: IMRT
- Number of Study Participants Experiencing Treatment-Related Toxicity [ Time Frame: 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.
- Percentage of Enrolled Patients for Whom LEAD RT Dose Can be Successfully Administered Following MRI-guided Planning. [ Time Frame: Up to 8 weeks ]The percentage of enrolled patients for whom LEAD RT dose can be successfully administered following MRI-guided planning.
- Number of Participants With Remaining Tumor Cells in the Prostate Post Treatment [ Time Frame: 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.
- 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) ]Preliminary indication of efficacy of treatment will be reported as the percentage of participants with positive prostate biopsies after completion of treatment.
- Rate of Participants That Achieve Failure-Free Survival (FFS) [ Time Frame: 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.
- Overall Survival (OS) [ Time Frame: 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.
- HrQoL as Assessed by EPIC-SF12 Questionnaire [ 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 ]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 [ 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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01411319
|United States, Florida|
|University of Miami|
|Miami, Florida, United States, 33136|
|Principal Investigator:||Alan Pollack, MD, PhD||University of Miami|