A Phase I Trial of MRI-Guided Lattice Extreme Ablative Dose Radiotherapy For Prostate Cancer

Inclusion Criteria:

• Biopsy confirmed adenocarcinoma of the prostate.

• T1-T2 disease based on digital rectal exam.

  • T3a disease based on MRI only is acceptable.
• Gleason score 6-8.

• Patients with Gleason score 8 must be offered long term androgen deprivation therapy (ADT) and refuse such treatment because only 6 months (short term ADT) is permitted on this protocol. All Gleason score 8 patients must receive 6 months of ADT. The ADT should begin after fiducial marker placement.

  • Gleason 8 must have <20% of the tissue involved with Gleason 8 in the biopsy specimen.
  • Patients with Gleason score ≤7 may be treated with 4-6 months of ADT. The ADT should begin after fiducial marker placement.
• Prostate-specific antigen (PSA) ≤20 ng/mL within 8 weeks of enrollment.
• No previous pelvic radiotherapy.
• No previous history of radical/total prostatectomy (suprapubic prostatectomy is acceptable).
• 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.

• Identifiable DCE-MRI tumor lesion or lesions, that total in volume <33% of the prostate

  • DCE-MRI of prostate and pelvis required prior to protocol consideration.
• Ability to understand and the willingness to sign a written informed consent document.
• Zubrod performance status <2.
• Willingness to fill out quality of life forms.
• Bone scan negative if PSA >10 ng/mL or Gleason ≥7 disease. A questionable bone scan is acceptable if plain x-rays and/or MRI are negative for metastasis.
• Serum testosterone is within 40% of normal assay limits and taken within 4 months of enrollment.
• Serum liver function tests (LFT) are within 40% of normal assay limits and taken within 8 weeks of enrollment.
• Complete blood counts are within 40% of normal assay limits, taken within 8 weeks of enrollment.
• Age ≥35 and ≤85 years.

Exclusion Criteria:

• >T2 disease on digital rectal exam unless T3a disease is identified by MRI.
• Gleason score <6 and >8.
• ≥20% Gleason 8 tumor, over the total tissue including other tumor and normal tissue. For example: (Gleason 8 tumor length/other biopsy tissue length)*100 = ≥20%.
• Patients are not eligible if they have been started on androgen deprivation therapy prior to enrollment.
• Androgen deprivation therapy longer than 6 months. Androgen deprivation timing is for the Luteinizing hormone-releasing hormone (LHRH) agonist portion only and not when anti-androgen is started beforehand.
• PSA >20 ng/mL within 8 weeks of enrollment.
• Unable to obtain a 3T MRI of the pelvis and prostate with contrast prior to randomization.
• Unidentifiable DCE-MRI tumor lesion.
• Identifiable DCE-MRI tumor lesions, that total in volume ≥33% of the prostate.
• Previous pelvic radiotherapy.
• Previous history of radical prostatectomy.
• 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.
• Zubrod performance status ≥ 2.
• Inability to understand or unwilling to sign a written informed consent document
• Unwilling to fill out quality of life/psychosocial forms.
• Bone scan is positive if PSA >10 ng/mL or Gleason ≥7 disease.
• Serum testosterone is not within 40% of normal assay limits taken within 4 months of enrollment.
• Serum liver function tests (LFTs) are not within 40% of normal assay limits taken within 8 weeks of enrollment.
• Complete blood counts are not within 40% of normal assay limits taken within 8 weeks of enrollment.
• Age <35 and >85 years.