adaptive stereotactic body radiation therapy to the prostate and pelvic nodes with simultaneous integrated boost to the mr-detected nodule for patients with high-risk and unfavorable intermediate-risk prostate cancer

Conditions: Prostate Cancer; Cancer of the Prostate

Summary: this trial is a prospective clinical trial designed to demonstrate the safety and feasibility of whole-pelvis adaptive prostate stereotactic body radiation therapy (sbrt) with a tumor boost to the magnetic resonance (mr)-detected sites of disease. the hypothesis is that this treatment approach will be safe and feasible with \<15% of patients experiencing an acute ctcaev5 grade ≥3 genitourinary (gu) or gastrointestinal (gi) adverse event.


Eligibility criteria:
inclusion criteria: * pathologically proven adenocarcinoma of the prostate with nccn high-risk disease or nccn unfavorable intermediate-risk disease. * patients with unfavorable intermediate-risk disease must meet the following criteria: * at least one intermediate risk factor (irf): * psa 10-20 ng/ml * ct2b-c (ajcc 8th ed.) * gleason score 7 * at least one "unfavorable" intermediate-risk identifier: * \> 1 irf * gleason score 4+3 * ≥ 50% of biopsy cores positive * no high-risk features * patients with high-risk disease must meet at least one of the following criteria: * ct3a-t3b * psa \> 20 * gleason score ≥ 8 * mri scan of the prostate with at least one mr-detectable lesion in the prostate/seminal vesicles. pet/ct which is found to display activity n the prostate consistent with prostate cancer may be substituted per investigator discretion. * planning to undergo concurrent whole-pelvis sbrt and androgen deprivation therapy (adt). adt may be initiated at any time per institutional standard, so long as adt begins within 60 days of the start of radiotherapy. * at least 18 years of age. * ecog performance status ≤ 1 * agreement to adhere to lifestyle considerations throughout study duration * able to complete relevant patient-reported quality-of-life questionnaires in the opinion of the treating physician. * able to understand and willing to sign an irb approved written informed consent document. exclusion criteria: * definitive radiologic evidence of nodal (cn+) or metastatic (cm1) disease on conventional imaging (bone scan) or prostate cancer-specific pet/ct scan (naf pet/ct, axumin pet/ct, fluciclovine, choline, or psma pet/ct scan). patients with lymph nodes ≥ 1 cm on short axis are ineligible unless the lymph node is read as benign by radiology. * prior androgen deprivation therapy. (if the onset of androgen ablation is ≤ 60 days prior to treatment start, the patient is eligible.) baseline psa and testosterone must be obtained prior to start of treatment. * systemic chemotherapy within 3 years prior to treatment start. * prior radical prostatectomy, pelvic lymph node dissection, prostate cryotherapy, or high-intensity focused ultrasound (hifu) to the prostate. * prior pelvic radiotherapy. * presence of baseline ctcae grade ≥ 2 gi or gu toxicity that does not resolve to grade 1 or less with appropriate intervention. * ct4 disease. * american urologic association (aua) urinary symptom score ≥ 20 * prostate gland measuring \>90 cc. * unable to get prostate fiducial markers placed for image guided radiation treatment. rectal hydrogel is optional and is left to the discretion of the treating physician. * hip prosthetic that does not allow for treatment planning visualization. * prior malignancy (except for non-melanoma skin cancer) unless disease-free for at least 2 years. patients are not eligible if they have had a prior pelvic malignancy (e.g. bladder cancer, rectal cancer). * prior transurethral resection of the prostate (turp) within 3 months prior to registration. * uncontrolled intercurrent illness precluding rt and/or adt including, but not limited to, seizures, myocardial infarction in the past 6 months, current severe or unstable angina pectoris, congestive heart failure requiring hospitalization in the past 6 months, uncontrolled active infection, uncontrolled hypertension, or any condition that in the opinion of the investigator would preclude participation in the study. * history of uncontrolled inflammatory bowel disease, including ulcerative colitis and crohn's disease. * presence of anal fissure or history of bowel or bladder fistula. * scleroderma. patients who are moderately symptomatic from other autoimmune diseases or patients on biologic therapies for autoimmune diseases are also excluded. * known history of hiv or chronic hepatitis b or c. testing to evaluate for the presence of hiv and/or hepatitis b or c is not required in patients who do not carry the diagnosis. * poorly visualized bladder and bowel on diagnostic ct or ct simulation (either due to body habitus or artifact). * unable to spend 30 minutes lying on the radiation therapy treatment couch due to significant urinary frequency/urgency or other comorbidities.

Keywords: prostate cancer stereotactic body radiation therapy sbrt whole pelvis prostate sbrt adaptive radiation tumor-directed boost