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.

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

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