Randomized MRI-Guided Prostate Boosts Via Initial Lattice Stereotactic vs Daily Moderately Hypofractionated Radiotherapy

NCT02307058 | Active Not Recruiting DMC FDA Device

• 1 other identifier: 20140627
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Rate of Early Prostate Tumor Response (EPTR)

  Prostate Tumor Pathologic Complete Response (PathCR measured using ultrasound guided systematic prostate biopsy) and/or early biochemical response at 9 months post-RT.

  Up to 3 years

Secondary Outcomes (8)

• Correlation between EPTR and Changes in serial post-RT MRIs

  3 months post-RT, 9-months post-RT, within 3 months of 2-2.5 post-treatment biopsy

• Number of participants experiencing treatment related adverse events

  Up to 2 years

• Health-Related Quality of Life Scores: EPIC SF-12

  Up to 5.25 years (post-treatment)

• Health-Related Quality of Life Scores: MAX-PC

  Up to 5.25 years (post-treatment)

• Health-Related Quality of Life Scores: IPSS

  Up to 5.25 years (post-treatment)

Study Arms (2)

LEAD RT Group

EXPERIMENTAL

Participants in this group will receive the Lattice Extreme Ablative Dose (LEAD) radiotherapy. Radiotherapy will begin within two months of fiducial marker placement. The therapy will consist of 39 fractions over approximately 8 weeks.

Radiation: LEAD RT

HEIGHT RT Group

EXPERIMENTAL

Participants in this group will receive the Hypofractionated Extended Image-Guided Highly Targeted (HEIGHT) radiotherapy. Radiotherapy will begin within two months of fiducial marker placement. The therapy will consist of 39 fractions over approximately 7 and a half weeks.

Radiation: HEIGHT RT

Interventions

LEAD RT RADIATION

The multiparametric-MRI (MP-MRI) defined Gross Tumor Volume (GTV) will receive 12-14 Gy on the first day of treatment and then the prostate plus proximal seminal vesicles (SV), the Clinical Target Volume (CTV)1, will receive 76 Gy in 38 fractions (Fxs) at 2.0 Gy per Fx. For High Risk patients, the distal SVs may be treated to 56 Gy in 38 Fxs or full dose (CTV2), and the pelvic lymph nodes may be treated to 56 Gy in 38 Fxs (CTV3).

Also known as: Stereotactic Lattice Radiation Therapy

LEAD RT Group

HEIGHT RT RADIATION

The MRI defined GTV(s) will receive a higher dose per day than the CTV by dose painting. The GTV(s) will receive an absolute dose of 91.2 Gy. Assuming an α/β ratio of 3.0, this would be equivalent to 98.5 Gy in 2.0 Gy fractions. The prostate plus proximal seminal vesicles (CTV1) will receive 76 Gy in 38 fractions (Fxs) at 2.0 Gy per Fx. For High Risk patients, the distal SVs (CTV2) may be treated to 56 Gy in 38 Fxs or full dose, and the pelvic lymph nodes (CTV3) may be treated to 56 Gy in 38 Fxs.

Also known as: Moderate Hypofractionation Radiation Therapy

HEIGHT RT Group

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Alan Pollack, MD, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 1, 2014
• First Posted: December 3, 2014
• Study Start: February 5, 2015
• Primary Completion (Estimated): July 31, 2029
• Study Completion (Estimated): July 31, 2031
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)