N/A
N=25
MRI-Guided Lattice Extreme Ablative Dose Radiotherapy For Prostate Cancer
Prostate Cancer · Prostate Adenocarcinoma
Bottom Line
View on ClinicalTrials.gov: NCT01411319 ↗Enrolled (actual)
25
Serious AEs
4.0%
Results posted
Jun 2021
Primary outcome: Primary: Number of Study Participants Experiencing Treatment-Related Toxicity — 0; 0; 1; 9 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Lattice Extreme Ablative Dose Radiation Therapy (Radiation); Standard IMRT (Radiation)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- Male
- Sponsor
- University of Miami
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Study Participants Experiencing Treatment-Related Toxicity |
0; 0; 1; 9; 10; 5 | — |
| PRIMARY Percentage of Enrolled Patients for Whom LEAD RT Dose Can be Successfully Administered Following MRI-guided Planning. |
100 | — |
| SECONDARY Number of Participants With Remaining Tumor Cells in the Prostate Post Treatment |
1 | — |
| SECONDARY Percentage of Participants With Positive Prostate Biopsies After Completion of Treatment |
4 | — |
| SECONDARY Rate of Participants That Achieve Failure-Free Survival (FFS) |
90.5 | — |
| SECONDARY Overall Survival (OS) |
66 | — |
| SECONDARY HrQoL as Assessed by EPIC-SF12 Questionnaire |
94.5; 92.5; 92.8; 93.1; 93.5; 93.2 | — |
| SECONDARY HrQoL as Assessed by MAX-PC Questionnaire |
13.7; 15.1; 13.3; 11.7; 12.6; 10 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Biopsy confirmed adenocarcinoma of the prostate.
- 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).
- Gleason score 6-10.
- 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 15 ng/mL or Gleason ≥ 8 disease. A questionable bone scan is acceptable if other imaging tests are negative for metastasis.
- 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.
- Serum liver function tests (LFT) are taken within 3 months of enrollment.
- Complete blood counts are taken within 3 months of enrollment.
- Age ≥ 35 and ≤ 85 years.
Exclusion Criteria
- > T3a disease on digital rectal exam or >T3a disease clearly identified by MRI.
- Gleason score 30 ng/mL within 3 months of enrollment.
- PSA > 30 ng/mL within 3 months of enrollment
- Unable to obtain a 1.5T or 3.0T multiparametric MRI of the pelvis and prostate with contrast.
- Unidentifiable multiparametric MRI tumor lesion.
- Identifiable multiparametric-MRI tumor lesions, that total in volume ≥ 33% of the prostate.
- Previous pelvic radiotherapy.
- Previous history of radical prostatectomy.
- 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 85 years.
Data sourced from ClinicalTrials.gov (NCT01411319). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.