Clinical trial NCT02307058: Randomized MRI-Guided Prostate Boosts Via Initial Lattice Stereotactic vs Daily Moderately Hypofractionated Radiotherapy
Official title: A Phase II Randomized Trial of MRI-Guided Prostate Boosts Via Initial Lattice Stereotactic vs Daily Moderately Hypofractionated Radiotherapy - The Miami BLaStM Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2014-12-03
Enrollment: 164
Sex: MALE
Minimum age (years): 35
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to learn about: 1) improving control of prostate cancer using an extra high dose radiation treatment to the MRI defined high risk tumor areas, in addition to the standard radiation treatment to the rest of the prostate; 2) preserving quality of life by reducing dose to the nearby organs at risk around the prostate; and 3) establishing the relationship of pre- and post-treatment MRI to MRI-directed biopsy results at 2-2.5 years after treatment.


Eligibility criteria: Eligibility Criteria:

* A. Biopsy confirmed adenocarcinoma (including ductal) of the prostate.
* B. T1-T3 disease based on digital rectal exam.
* C. No evidence of metastasis by any clinical criteria or available radiographic tests (N0M0 by clinical or imaging criteria).
* D. Gleason score 6-10.
* E. Androgen deprivation therapy (ADT) is at the discretion of the treating physician; but, must be decided (none, short-term or long-term as counted from the luteinizing hormone-releasing hormone (LHRH) agonist or antagonist injection) prior to enrollment. An anti-androgen (e.g., bicalutamide at 50 mg per day po) is recommended to start prior to LHRH agonist injection (not recommended for LHRH antagonist injection) and is recommended to not be administered for more than 4 months. If ADT is planned, the following restrictions apply:

  * i. It may be initiated no more than 3 months prior to the signing of consent
  * ii. It must be started prior to the start of radiotherapy and
  * iii. The total length planned must be ≤ 30 months
* F. Prostate-specific Antigen (PSA) ≤ 100 ng/mL within (+/-) 4 months of signing of consent. If PSA was above 100 and drops to ≤ 100 with antibiotics, this is acceptable for enrollment.
* G. Subjects with T3 disease based on digital rectal exam (DRE), Gleason 8-10 or a PSA of \>15 ng/ml, should have a bone scan within (+/-) 4 months of signing of consent that is without evidence of metastasis. A questionable bone scan is acceptable if additional imaging studies (e.g., plain x-rays, CT, or MRI) do not confirm for metastasis.
* H. Suspicious peripheral zone or central gland lesion on MP-MRI

  * i. Peripheral zone: Distinct lesion on dynamic contrast-enhanced MRI (DCE-MRI) with early enhancement and later washout (Note: contrast not required for enrollment), and/or distinct lesion on the ADC map (Value \<1000).
  * ii. Central gland: A suspicious central gland lesion on MP-MRI must have a distinct lesion on the apparent diffusion coefficient (ADC) map (Value \<1000)
* I. No previous pelvic radiotherapy.
* J. No previous history of radical/total prostatectomy (suprapubic prostatectomy is acceptable).
* K. 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.
* L. Ability to understand and the willingness to sign a written informed consent document.
* M. Zubrod performance status ≤ 2. (Karnofsky or Eastern Cooperative Oncology Group (ECOG) performance status may be used to estimate Zubrod).
* N. Willingness to fill out quality of life/psychosocial forms.
* O. Age ≥ 35 and ≤ 85 years at signing of consent.

Primary outcomes:
measure: Rate of Early Prostate Tumor Response (EPTR)
timeFrame: Up to 3 years
Secondary outcomes:
measure: Correlation between EPTR and Changes in serial post-RT MRIs
timeFrame: 3 months post-RT, 9-months post-RT, within 3 months of 2-2.5 post-treatment biopsy
measure: Number of participants experiencing treatment related adverse events
timeFrame: Up to 2 years
measure: Health-Related Quality of Life Scores: EPIC SF-12
timeFrame: Up to 5.25 years (post-treatment)
measure: Health-Related Quality of Life Scores: MAX-PC
timeFrame: Up to 5.25 years (post-treatment)
measure: Health-Related Quality of Life Scores: IPSS
timeFrame: Up to 5.25 years (post-treatment)
measure: Change in gene/biomarker expression
timeFrame: Baseline, Up to 5.25 years (post-treatment)
measure: Rate of participant response
timeFrame: Up to 5.25 years (post-treatment)
measure: Change in CTC Levels
timeFrame: Baseline (pre-treatment), Up to 2 years (post-treatment)
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Alan Pollack, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: