Hypofractionated Image-Guided Radiotherapy For Prostate Cancer: The HEIGHT Trial

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.