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

Trial Title: 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

NCT ID: NCT05628363

Condition: Prostate Cancer
Cancer of the Prostate

Conditions: Official terms:
Prostatic Neoplasms
Androgens

Conditions: Keywords:
Prostate cancer
stereotactic body radiation therapy
SBRT
whole pelvis prostate SBRT
adaptive radiation
tumor-directed boost

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Device
Intervention name: Ethos Varian treatment system
Description: Device that will be used to administer radiotherapy
Arm group label: Adaptive stereotactic body radiotherapy (SBRT)

Intervention type: Radiation
Intervention name: Adaptive stereotactic body radiotherapy
Description: Radiotherapy interruptions are acceptable as long as treatments are no more than 16 days apart.
Arm group label: Adaptive stereotactic body radiotherapy (SBRT)

Other name: SBRT

Intervention type: Drug
Intervention name: Androgen deprivation therapy
Description: Androgen deprivation therapy (ADT) will be administered to study patients according to institutional standard. Patients should initiate ADT beginning no sooner than 60 days prior to start of radiation. ADT is defined as a GnRH agonist/antagonist (leuprolide, goserelin, degarelix, or relugolix). Patients treated with leuprolide, goserelin, or degarelix should also receive an androgen receptor antagonist (flutamide or bicalutamide) for 30 days from the start of GnRH agonist/antagonist or until the end of radiation, depending on institutional standard and physician preference. Agent selection is per treating physician discretion and will be administered per institutional standard and FDA-approved labeling.
Arm group label: Adaptive stereotactic body radiotherapy (SBRT)

Other name: ADT

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.

Criteria for 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.

Gender: Male

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Washington University School of Medicine

Address:
City: Saint Louis
Zip: 63110
Country: United States

Status: Recruiting

Contact:
Last name: Amit Bhatt, M.D., Ph.D.

Phone: 314-747-7236
Email: amitb@wustl.edu

Investigator:
Last name: Amit Bhatt, M.D., Ph.D.
Email: Principal Investigator

Investigator:
Last name: Eric Laugeman, M.S.
Email: Sub-Investigator

Investigator:
Last name: Jeff Michalski, M.D., MBA, FASTRO
Email: Sub-Investigator

Investigator:
Last name: Yi Huang, M.S.
Email: Sub-Investigator

Investigator:
Last name: Hiram Gay, M.D.
Email: Sub-Investigator

Start date: January 18, 2023

Completion date: January 31, 2031

Lead sponsor:
Agency: Washington University School of Medicine
Agency class: Other

Collaborator:
Agency: Varian Medical Systems
Agency class: Industry

Source: Washington University School of Medicine

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05628363
http://www.siteman.wustl.edu