Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
H. Lee Moffitt Cancer Center and Research Institute
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
Histologically proven prostate adenocarcinoma.
Clinical stage ≤T3a based on digital rectal exam (DRE) and ≤T3a based on MRI (within 3 months); N0-Nx; M0-Mx, or Gleason score 4 + 4. No more than 1 lymph node \>1 cm.
PSA ≤ 50 ng/ml, obtained within 3 months
Prostate volume: ≤60 cc.
IPSS score ≤15.
No previous radiotherapy to the prostate or lower pelvis.
Lymph node risk of \<35% using https://www.mskcc.org/nomograms/prostate/pre\_op.
No prior radical prostatectomy or cryotherapy of the prostate (prior transurethral resection or laser ablation are permitted).
No implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion.
No history of an invasive malignancy (other than this prostate cancer, or non-metastatic basal or squamous skin cancers) in the last 3 years.
No androgen deprivation therapy (ADT) can be prescribed prior to or during radiation therapy.
Participant must be able to have gold fiducial markers placed in the prostate. Note: patients can be enrolled after fiducial markers have been placed, as long as the procedure was done in accordance with the protocol (Section 4.2.2).
Eastern Cooperative Oncology Group (ECOG) performance status ≤2
Ability to understand and the willingness to sign a written informed consent document.
Willing to fill out quality of life questionnaires.
Clareo Health | Single Arm Trial of Preoperative Stereotactic Body Radiation Therapy (SBRT) for T3a or Gleason Grade Group 4 Prostate Cancer
