A Phase I Trial of MRIGuided Lattice Extreme Ablative Dose Radiotherapy For Prostate Cancer

Investigator: Alan Pollack

Institutional Protocol #: 20100389

National Clinical Trials Identifier: NCT01411319

Funding Agency/Sponsor: Intramural

Division: Cancer Center

Therapeutic Area: Prostate, Bladder, and Kidney Cancers

Phase: Phase I

Enrolling Sites: University of Miami Hospital & Clinics, UMD

Enrolling Since: 8/13/2014


Purpose/Abstract:


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.

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.




Eligibility Criteria:


Inclusion Criteria:

- A. Biopsy confirmed adenocarcinoma of the prostate.

- B. 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).

- C. Gleason score 6-10.

- D. 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.

- E. 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.

- F. No previous pelvic radiotherapy.

- G. No previous history of radical/total prostatectomy (suprapubic prostatectomy is
acceptable).

- H. 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.

- I. 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.

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

- K. Zubrod performance status < 2.

- L. Willingness to fill out quality of life forms.

- M. Bone scan negative if PSA > 15 ng/mL or Gleason ≥ 8 disease. A questionable bone
scan is acceptable if other imaging tests are negative for metastasis.

- N. Serum testosterone is within 40% of normal assay limits (e.g., x=0.4*lower assay
limit and x=.04*upper assay limit + upper assay limit), and taken within 4 months of
enrollment. Patients who have been started on ADT prior to signing consent are not
required to have a serum testosterone at this level prior to signing consent; but, a
serum testosterone prior to fiducial marker placement is recommended.

- O. Serum liver function tests (LFT) are taken within 3 months of enrollment.

- P. Complete blood counts are taken within 3 months of enrollment.

- Q. Age ≥ 35 and ≤ 85 years.

Exclusion Criteria:

- A. > T3a disease on digital rectal exam or >T3a disease clearly identified by MRI.

- B. Gleason score < 6.

- C. >= 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%.

- D. 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.

- E. PSA > 30 ng/mL within 3 months of enrollment

- F. Unable to obtain a 1.5T or 3.0T multiparametric MRI of the pelvis and prostate
with contrast.

- G. Unidentifiable multiparametric MRI tumor lesion.

- H. Identifiable multiparametric-MRI tumor lesions, that total in volume ≥ 33% of the
prostate.

- I. Previous pelvic radiotherapy.

- J. Previous history of radical prostatectomy.

- K. 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.

- L. Zubrod performance status ≥ 2.

- M. Inability to understand or unwilling to sign a written informed consent document

- N. Unwilling to fill out quality of life/psychosocial forms.

- O. Bone scan is positive and other imaging tests confirm a suspicion of metastasis
from prostate cancer.

- P. Serum testosterone is not within 40% of normal assay limits taken within 4 months
of enrollment (only applicable to patients not started on ADT prior to signing
consent).

- Q. Serum liver function tests (LFTs) are not taen within 3 months of enrollment.

- R. Complete blood counts are not taken within 3 months of enrollment.

- S. Age < 35 and > 85 years.


Gender: Male

Minimum Age: 35 Years

Maximum Age: 85 Years

Accepts healthy volunteers: No

Please note that this is written for scientific review, and if there are any questions or clarifications needed, please contact

Cancer Center Studies
1-866-574-5124

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