Adults 35 to 85, male only, with Prostate Cancer or Prostate Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Study Participants Experiencing Treatment-Related ToxicityPrimary· 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.
Serious Adverse Events (SAEs) with Definite Relation to Study Treatment
Group
Value
95% CI
LEAD Radiation Therapy
0
SAEs with Probable Relation to Study Treatment
Group
Value
95% CI
LEAD Radiation Therapy
0
SAEs with Possible Relation to Study Treatment
Group
Value
95% CI
LEAD Radiation Therapy
1
Adverse Events (AEs) with Definite Relation to Study Treatment
Group
Value
95% CI
LEAD Radiation Therapy
9
AEs with Probable Relation to Study Treatment
Group
Value
95% CI
LEAD Radiation Therapy
10
AEs with Possible Relation to Study Treatment
Group
Value
95% CI
LEAD Radiation Therapy
5
Percentage of Enrolled Patients for Whom LEAD RT Dose Can be Successfully Administered Following MRI-guided Planning.Primary· Up to 8 weeks
The percentage of enrolled patients for whom LEAD RT dose can be successfully administered following MRI-guided planning.
Group
Value
95% CI
LEAD Radiation Therapy
100
Number of Participants With Remaining Tumor Cells in the Prostate Post TreatmentSecondary· 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.
Group
Value
95% CI
LEAD Radiation Therapy
1
Percentage of Participants With Positive Prostate Biopsies After Completion of TreatmentSecondary· 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.
Group
Value
95% CI
LEAD Radiation Therapy
4
0.7 – 19.5
Rate of Participants That Achieve Failure-Free Survival (FFS)Secondary· 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.
Group
Value
95% CI
LEAD Radiation Therapy
90.5
Overall Survival (OS)Secondary· 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.
Group
Value
95% CI
LEAD Radiation Therapy
66
20.7 – 70.6
HrQoL as Assessed by EPIC-SF12 QuestionnaireSecondary· 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.
Urinary Function: Prior to Radiation Therapy (RT)
Group
Value
95% CI
LEAD Radiation Therapy
94.5
± 10.9
Urinary Function: 8 Weeks (Last Week of RT)
Group
Value
95% CI
LEAD Radiation Therapy
92.5
± 14.4
Urinary Function: 6 Weeks Post-RT
Group
Value
95% CI
LEAD Radiation Therapy
92.8
± 20
Urinary Function: 3 Months Post-RT
Group
Value
95% CI
LEAD Radiation Therapy
93.1
± 17.6
Urinary Function: 9 Months Post-RT
Group
Value
95% CI
LEAD Radiation Therapy
93.5
± 16.6
Urinary Function: 15 Months Post-RT
Group
Value
95% CI
LEAD Radiation Therapy
93.2
± 14.5
Urinary Function: 27 Months Post-RT
Group
Value
95% CI
LEAD Radiation Therapy
93.6
± 15.5
Urinary Function: 39 Months Post-RT
Group
Value
95% CI
LEAD Radiation Therapy
95.8
± 9.2
HrQoL as Assessed by MAX-PC QuestionnaireSecondary· 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.
Prior to Radiation Therapy (RT)
Group
Value
95% CI
LEAD Radiation Therapy
13.7
± 6.3
8 Weeks (Last Week of RT)
Group
Value
95% CI
LEAD Radiation Therapy
15.1
± 7.2
6 Weeks Post-RT
Group
Value
95% CI
LEAD Radiation Therapy
13.3
± 7.5
3 Months Post-RT
Group
Value
95% CI
LEAD Radiation Therapy
11.7
± 7.5
9 Months Post-RT
Group
Value
95% CI
LEAD Radiation Therapy
12.6
± 7.5
15 Months Post-RT
Group
Value
95% CI
LEAD Radiation Therapy
10
± 6.9
27 Months Post-RT
Group
Value
95% CI
LEAD Radiation Therapy
12.2
± 6.1
39 Months Post-RT
Group
Value
95% CI
LEAD Radiation Therapy
12.3
± 7.2
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 6 years.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
LEAD Radiation Therapy
Serious: 1/25 (4%)
Deaths: 1/25
Serious adverse events (1 terms)
Reaction
System
LEAD Radiation Therapy
Urinary Tract Infection
Renal and urinary disorders
—
Other adverse events (41 terms — click to expand)
Reaction
System
LEAD Radiation Therapy
Urinary frequency
Renal and urinary disorders
—
Urinary urgency
Renal and urinary disorders
—
Cystitis noninfective
Renal and urinary disorders
—
Fatigue
General disorders
—
Diarrhea
Gastrointestinal disorders
—
Urinary retention
Renal and urinary disorders
—
Urinary obstructive symptoms, urinary hesitancy, increased frequency of bowel movement (no diarrhea)
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Miami
Last refreshed: 13 July 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01411319.