Tumor TARGET Prostate Cancer

This is a prospective two arm phase 2 trial investigating the technical and clinical performance of tumor-targeted (rather than prostate targeted) radiotherapy.

Cohort 1 (Control group): This group consists of patients who have had previous radiation. This group will not receive any active treatment but will have a biopsy at 3 years from the time they completed their radiation therapy. Patient in this group will also continue to have their PSA checked per standard practice

Cohort 2 (Experimental group): Patients in this group will receive one of 2 treatment arms of their choice. In addition to the MRI-guided prostate biopsy at 3 years and regular standard of care PSA checks, this group will also complete a quality of life questionnaire and have regular imaging per standard practice.

Both groups will be followed by the research team per protocol.

Inclusion criteria

[applicable to both Cohorts 1 (control) and Cohort 2 (Experimental) unless otherwise specified]:

• Histological evidence of prostate adenocarcinoma.
• Discrete intra-prostatic tumor that can be confidently visualized on MRI prior to radiotherapy (>5mm maximum diameter but <33% of prostate volume, biopsy confirmed from initial diagnosis or interventional Biopsy) )
• At least 18 years old
• ECOG performance status 0 or 1
• Informed consent: All patients must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed (this does not include standard care laboratory tests or imaging studies).
• Patients will be one of the following risk groups prior to therapy:

• Low-risk disease (Gleason 6 and PSA <10 and T1) AND >50% of biopsy cores involved with tumor
• Intermediate-risk disease (Gleason 7 or PSA 10-20 or T2)
• High-risk disease (Gleason >8 or T3 or PSA >20)
• Risk of LN involvement <30% (Roach formula = 2/3PSA([G-6]x10))
• Patients who received 78Gy RT to the prostate gland 3-4.5 years prior to enrollment (Cohort 1 only)

Exclusion criteria

[applicable to both Cohorts 1 (control) and Cohort 2(Experimental) unless otherwise specified]:

• Previous history of radiation therapy to the prostate (Cohort 2)
• Diagnosis of another cancer not being skin cancer within the last 5 years (Cohort 2)
• Patients weight as per MRI Technologist's discretion
• Patients with contraindications to MRI: this includes patients with pacemakers, cerebral aneurysm clips, shrapnel injury or implantable electronic devices not compatible with MRI determination. Exceptions will be allowed if deemed sage and appropriate by the MRI technologist.
• Severe claustrophobia
• Bleeding diathesis and anti-coagulative therapy that cannot be temporarily ceased precluding biopsy
• Current hormonal therapy (Cohort 1) or initiated >2 weeks prior to enrollment (Cohort 2)
• Radiological evidence of regional or distant metastases (Cohort 2)
• Other urinary or medical conditions deemed by the PI or associates to make the patient ineligible for MRI-guided prostate biopsy
• Contraindications to the endorectal coil, surgically absent rectum, severe hemorrhoids or previous colorectal surgery
• Contraindications to conscious sedation
• Latex allergy
• History of Ulcerative Colitis, Crohn's Disease, Ataxia Telangiectasia, or SLE (Cohort 2)
• Other medical conditions deemed by the PI to make patient ineligible for study intervention