A Phase III Trial Of Hypofractionated External Beam ImageGuided Highly Targeted Radiotherapy for Prostate Cancer: The HEIGHT Trial

Investigator: Alan Pollack

Institutional Protocol #: 20100635

National Clinical Trials Identifier: NCT01411332

Funding Agency/Sponsor: BANKHEAD COLEY FL BIOMEDICAL CANCER RES PROG

Division: Cancer Center

Therapeutic Area: Prostate, Bladder, and Kidney Cancers

Phase: Phase III

Enrolling Sites: University of Miami Hospital & Clinics, UMD

Enrolling Since: 6/21/2017


Purpose/Abstract:


1. Delivery of directed hypofractionated targeted (HT) radiotherapy (RT) tumor boost to
the dominant tumor lesion in the prostate as identified by multiparametric MRI will
increase tumor eradication from the prostate.

2. Biomarker expression levels differ in the multiparametric MRI defined regions at high
risk of harboring tumors that determine outcome.

3. 10-15% of men undergoing RT have Circulating DNA or tumor cells (CTC) that are related
to an adverse treatment outcome.

4. Quality of life will not differ significantly between the treatment arms.

5. Prostate cancer-related anxiety will be reduced in the HTIMRT arm, because the patients
will be aware that the dominant tumor will be targeted with higher radiation dose.




Eligibility Criteria:


Inclusion Criteria:

- A. Biopsy confirmed adenocarcinoma of the prostate.

- B. T1-T3a disease based on digital rectal exam.

1. T1a is permitted if peripheral zone biopsies are positive.

2. T3a disease based on MRI is acceptable.

- C. No evidence of metastasis by any clinical criteria or available radiographic
tests.

- D. Gleason score 6-8.

- E. Patients with Gleason score 8 must be offered long term androgen deprivation
therapy (ADT) and refuse such treatment because only 4-6 (±2 months) months (short
term ADT) is permitted on this protocol. Gleason score ≥ 8 patients should be
recommended to receive short term ADT in conjunction with RT. When given, the ADT
recommended to begin after fiducial marker placement, if applicable; however, ADT is
permitted to have been started up to two months prior to the signing of consent.

1. Patients with Gleason score 8 disease must have <40 of the diagnostic tumor
tissue involved with tumor.

2. Patients with Gleason score ≤7 may be treated with 4-6 (±2 months) months of
ADT.

- F. PSA ≤100 ng/mL within 3 months of enrollment. If PSA was above 100 and dropped to
≤100 with antibiotics, this is acceptable for enrollment.

- G. If PSA is >15 ng/ml or there is ≥ Gleason 8 disease, a bone scan should be
obtained ≤4 months before enrollment and should be without evidence of metastasis. A
questionable bone scan is acceptable if plain x-rays, CT and/or MRI are negative for
metastasis.

- H. No previous pelvic radiotherapy

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

- J. 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.

- K. Identifiable multiparameter functional MRI defined tumor lesion or lesions using a
1.5T or 3.0T MRI (3.0T preferable), that total in volume <33% of the prostate within
3 months prior to enrollment.

a. Multiparametric functional including diffusion weighted imaging (DWI) of prostate
and pelvis is required prior to protocol consideration

- 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.

- P. 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),, 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.

- Q. Serum liver function tests (LFTs) taken within 3 months of enrollment.

- R. Complete blood counts taken within 3 months of enrollment.

Exclusion Criteria

- A. Previous pelvic radiotherapy.

- B. Previous history of radical prostatectomy.

- C. 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

- D. Not willing to fill out quality of life/psychosocial questionnaires.


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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