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A Phase I Trial of MRI-Guided Lattice Extreme Ablative Dose Radiotherapy For Prostate Cancer


Phase 1
35 Years
85 Years
Open (Enrolling)
Male
Prostate Cancer, Prostate Adenocarcinoma

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Trial Information

A Phase I Trial of MRI-Guided Lattice Extreme Ablative Dose Radiotherapy For Prostate Cancer


The investigators propose to use a novel method for delivery of ablative spatially
fractionated radiation to the DCE-MRI defined tumor volume in the framework of a single-arm
phase I clinical trial. The technique, deemed Lattice Extreme Ablative Dose (LEAD) RT,
involves the creation of high doses shaped in cylinders through the DCE-MRI defined
region(s) and adjacent apparently normal prostate in a lattice framework. The LEAD RT
delivery will be in a single fraction of 12-14 Gy prior to standard fractions (2.0 Gy per
day) for an additional 76 Gy (total dose for all treatments of 88-90 Gy and 149 Gy3.0 in 2.0
Gy equivalents).

In this protocol the investigators also aim to examine biomarkers obtained from
ultrasound-guided biopsies. Emphasis will be placed on biopsying regions in which the
DCE-MRI shows enhancement. The DCE-MRI will be viewed on a separate monitor during the
ultrasound-guided biopsies to enhance the probability of obtained biomarkers more
representative of patient outcome. Biomarkers from biopsies from the index lesion(s) will be
compared to those from tumor in other areas of the prostate. Biopsy tissues will be
collected pre- and post-treatment and analyzed by immunohistochemistry (IHC) for biomarker
quantification.


Inclusion Criteria:



- Biopsy confirmed adenocarcinoma of the prostate.

- T1-T2 disease based on digital rectal exam.

- T3a disease based on MRI only is acceptable.

- Gleason score 6-8.

- Patients with Gleason score 8 must be offered long term androgen deprivation therapy
(ADT) and refuse such treatment because only 6 months (short term ADT) is permitted
on this protocol. All Gleason score 8 patients must receive 6 months of ADT. The ADT
should begin after fiducial marker placement.

- Gleason 8 must have <20% of the tissue involved with Gleason 8 in the biopsy
specimen.

- Patients with Gleason score ≤7 may be treated with 4-6 months of ADT. The ADT
should begin after fiducial marker placement.

- Prostate-specific antigen (PSA) ≤20 ng/mL within 8 weeks of 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 DCE-MRI tumor lesion or lesions, that total in volume <33% of the
prostate

- DCE-MRI of prostate and pelvis required prior to protocol consideration.

- Ability to understand and the willingness to sign a written informed consent
document.

- Zubrod performance status <2.

- Willingness to fill out quality of life forms.

- Bone scan negative if PSA >10 ng/mL or Gleason ≥7 disease. A questionable bone scan
is acceptable if plain x-rays and/or MRI are negative for metastasis.

- Serum testosterone is within 40% of normal assay limits and taken within 4 months of
enrollment.

- Serum liver function tests (LFT) are within 40% of normal assay limits and taken
within 8 weeks of enrollment.

- Complete blood counts are within 40% of normal assay limits, taken within 8 weeks of
enrollment.

- Age ≥35 and ≤85 years.

Exclusion Criteria:

- >T2 disease on digital rectal exam unless T3a disease is identified by MRI.

- Gleason score <6 and >8.

- ≥20% Gleason 8 tumor, over the total tissue including other tumor and normal tissue.
For example: (Gleason 8 tumor length/other biopsy tissue length)*100 = ≥20%.

- Patients are not eligible if they have been started on androgen deprivation therapy
prior to enrollment.

- Androgen deprivation therapy longer than 6 months. Androgen deprivation timing is for
the Luteinizing hormone-releasing hormone (LHRH) agonist portion only and not when
anti-androgen is started beforehand.

- PSA >20 ng/mL within 8 weeks of enrollment.

- Unable to obtain a 3T MRI of the pelvis and prostate with contrast prior to
randomization.

- Unidentifiable DCE-MRI tumor lesion.

- Identifiable DCE-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 if PSA >10 ng/mL or Gleason ≥7 disease.

- Serum testosterone is not within 40% of normal assay limits taken within 4 months of
enrollment.

- Serum liver function tests (LFTs) are not within 40% of normal assay limits taken
within 8 weeks of enrollment.

- Complete blood counts are not within 40% of normal assay limits taken within 8 weeks
of enrollment.

- Age <35 and >85 years.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Patients with Adverse Events in a Phase 1 LEAD RT Clinical Trial

Outcome Description:

To determine the number of patients with and severity of adverse events in a Phase 1 LEAD RT clinical trial.

Outcome Time Frame:

5.25 years

Safety Issue:

Yes

Principal Investigator

Alan Pollack, MD. PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Miami Sylvester Comprehensive Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

EPROST-20100389

NCT ID:

NCT01411319

Start Date:

October 2010

Completion Date:

Related Keywords:

  • Prostate Cancer
  • Prostate Adenocarcinoma
  • Prostate Cancer
  • Prostate Adenocarcinoma
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Prostatic Neoplasms

Name

Location

University of Miami Sylvester Comprehensive Cancer CenterMiami, Florida  33136