MRI-Guided Lattice Extreme Ablative Dose Radiotherapy For Prostate Cancer

Inclusion Criteria:

1. Biopsy confirmed adenocarcinoma of the prostate.
2. 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).
3. Gleason score 6-10.
4. 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.
5. 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.
6. No previous pelvic radiotherapy.
7. No previous history of radical/total prostatectomy (suprapubic prostatectomy is acceptable).
8. 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.
9. 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.
10. Ability to understand and the willingness to sign a written informed consent document.
11. Zubrod performance status \< 2.
12. Willingness to fill out quality of life forms.
13. 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.
14. 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.
15. Serum liver function tests (LFT) are taken within 3 months of enrollment.
16. Complete blood counts are taken within 3 months of enrollment.
17. Age ≥ 35 and ≤ 85 years.

Exclusion Criteria:

1. \> T3a disease on digital rectal exam or \>T3a disease clearly identified by MRI.
2. Gleason score \< 6.
3. ≥ 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%.
4. 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.
5. PSA \> 30 ng/mL within 3 months of enrollment
6. Unable to obtain a 1.5T or 3.0T multiparametric MRI of the pelvis and prostate with contrast.
7. Unidentifiable multiparametric MRI tumor lesion.
8. Identifiable multiparametric-MRI tumor lesions, that total in volume ≥ 33% of the prostate.
9. Previous pelvic radiotherapy.
10. Previous history of radical prostatectomy.
11. 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.
12. Zubrod performance status ≥ 2.
13. Inability to understand or unwilling to sign a written informed consent document
14. Unwilling to fill out quality of life/psychosocial forms.
15. Bone scan is positive and other imaging tests confirm a suspicion of metastasis from prostate cancer.
16. 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).
17. Serum liver function tests (LFTs) are not taken within 3 months of enrollment.
18. Complete blood counts are not taken within 3 months of enrollment.
19. Age \< 35 and \> 85 years.