MRI-Guided Lattice Extreme Ablative Dose Radiotherapy For Prostate Cancer

NCT01411319 | Completed Results DMC FDA Device

• 2 other identifiers: 20100389R21CA153826
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The hypotheses of this study are:

1. 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. 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.

Conditions

Prostate Cancer; Prostate Adenocarcinoma

Outcome Measures

Primary Outcomes (2)

• Number of Study Participants Experiencing Treatment-Related Toxicity

  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.

  Up to 8.5 weeks

• Percentage of Enrolled Patients for Whom LEAD RT Dose Can be Successfully Administered Following MRI-guided Planning.

  The percentage of enrolled patients for whom LEAD RT dose can be successfully administered following MRI-guided planning.

  Up to 8 weeks

Secondary Outcomes (6)

• Number of Participants With Remaining Tumor Cells in the Prostate Post Treatment

  Up to 2.5 Years

• Percentage of Participants With Positive Prostate Biopsies After Completion of Treatment

  From Baseline to 2.5 Years Post Completion of Study Therapy (Approximately 3 years)

• Rate of Participants That Achieve Failure-Free Survival (FFS)

  Up to 6 years

• Overall Survival (OS)

  Up to 6 years

• HrQoL as Assessed by EPIC-SF12 Questionnaire

  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

Study Arms (1)

LEAD Radiation Therapy

EXPERIMENTAL

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; Radiation: Standard IMRT

Interventions

Lattice Extreme Ablative Dose Radiation Therapy RADIATION

12 - 14 Gy dose pipes in 1 fraction to the multiparametric MRI defined gross tumor volumes (GTV) on Day 1.

Also known as: LEAD RT

LEAD Radiation Therapy

Standard IMRT RADIATION

76 Gy in 38 fractions (2 Gy daily) of Standard Intensity-modulated radiation therapy (IMRT) starting on Day 2 for 7.5 weeks.

Also known as: IMRT

LEAD Radiation Therapy

Eligibility Criteria

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

You may qualify if:

• 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 \< 40% of the tissue involved with Gleason 8 in the biopsy specimen.
• Prostate-specific antigen (PSA) ≤ 30 ng/mL within 3 months of enrollment. If PSA was above 30 and dropped to ≤ 30 with antibiotics, this is acceptable for enrollment.
• No previous pelvic radiotherapy.
• No previous history of radical/total prostatectomy (suprapubic prostatectomy is acceptable).
• 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.
• Identifiable multiparametric-MRI tumor lesion or lesions, that total in volume \< 33% of the prostate
• Multiparametric MRI of prostate and pelvis is required prior to protocol consideration.
• If contrast not given, the point dose on the apparent diffusion coefficient (ADC) map should be \< 1000.
• Ability to understand and the willingness to sign a written informed consent document.
• Zubrod performance status \< 2.

You may not qualify if:

• \> T3a disease on digital rectal exam or \>T3a disease clearly identified by MRI.
• Gleason score \< 6.
• ≥ 40% Gleason 8-10 tumor, over the total tissue including other tumor and normal tissue. For example: (Gleason 8-10 tumor length/other biopsy tissue length)\*100 = ≥ 40%.
• Androgen deprivation therapy longer than 8 months. Androgen deprivation timing is for the Luteinizing hormone-releasing hormone (LHRH) agonist portion only and not when anti-androgen is started beforehand with the purpose of counteracting the surge in testosterone from the LHRH agonist - PSA \> 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 \< 5 years then the patient is not eligible.
• Zubrod performance status ≥ 2.
• Inability to understand or unwilling to sign a written informed consent document
• Unwilling to fill out quality of life/psychosocial forms.
• Bone scan is positive and other imaging tests confirm a suspicion of metastasis from prostate cancer.

Sponsors & Collaborators

• University of Miami: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

Related Publications (1)

• Pollack A, Chinea FM, Bossart E, Kwon D, Abramowitz MC, Lynne C, Jorda M, Marples B, Patel VN, Wu X, Reis I, Studenski MT, Casillas J, Stoyanova R. Phase I Trial of MRI-Guided Prostate Cancer Lattice Extreme Ablative Dose (LEAD) Boost Radiation Therapy. Int J Radiat Oncol Biol Phys. 2020 Jun 1;107(2):305-315. doi: 10.1016/j.ijrobp.2020.01.052. Epub 2020 Feb 19.

  PMID: 32084522 RESULT

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

Results Point of Contact

• Title: Alan Pollack, MD, PhD
• Organization: University of Miami

apollack@med.miami.edu

305-243-4916

Study Officials

• Alan Pollack, MD, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: August 3, 2011
• First Posted: August 8, 2011
• Study Start: December 27, 2011
• Primary Completion: December 31, 2014
• Study Completion: March 2, 2020
• Last Updated: July 13, 2021
• Results First Posted: June 16, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)