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

NCT05628363 | Active Not Recruiting DMC FDA Device

• 1 other identifier: 202211121
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer; Cancer of the Prostate

Keywords

Prostate cancer; stereotactic body radiation therapy; SBRT; whole pelvis prostate SBRT; adaptive radiation; tumor-directed boost

Outcome Measures

Primary Outcomes (1)

• Rate of acute grade ≥3 GI and GU adverse events

  From start of radiotherapy through 90 days after start of radiotherapy

Secondary Outcomes (4)

• Changes in patient-reported quality of life as measured by EPIC-26

  At screening, end of radiotherapy (week 5), 3 months after start of radiotherapy, and every 3 months until month 24

• Changes in global function as measured by EQ-5D-5L

  At screening, end of radiotherapy (week 5), 3 months after start of radiotherapy, and every 3 months until month 24

• Rate of acute grade ≥3 adverse events at least possibly related to radiotherapy

  From start of radiotherapy through 90 days after start of radiotherapy

• Rate of acute <grade 3 GI and GU adverse events

  From start of radiotherapy through 90 days after start of radiotherapy

Other Outcomes (6)

• Rate of late GI and GU adverse events

  From day 91 after the start of radiotherapy until completion of follow-up at month 60

• Failure-free survival

  From start of radiotherapy until completion of follow-up (estimated to be 60 months)

• Biochemical recurrence free-survival

  From start of radiotherapy until completion of follow-up (estimated to be 60 months)

Study Arms (1)

Adaptive stereotactic body radiotherapy (SBRT)

EXPERIMENTAL

* Treatment consists of adaptive dose-escalated stereotactic body radiotherapy (SBRT) to the pelvic nodes to 25 Gy in 5 once or twice weekly fractions with simultaneous integrated boosts (SIB) to the prostate and proximal seminal vesicles to 36.25 Gy in 5 fractions (full seminal vesicles if involved), to the prostate to 40 Gy in 5 fractions, and to the involved MR-detected nodule(s) to up to 50 Gy in 5 fractions. * Androgen deprivation therapy (ADT) will be administered to study patients according to institutional standard. Unfavorable Intermediate-risk Disease: Patients should receive a minimum of 4 months of ADT. Patients can receive longer duration of ADT at the discretion of the treating physician. High-risk disease: Patients should receive a minimum of 1 year of ADT. Patients can receive up to 2 years of ADT at the discretion of the treating physician.

Device: Ethos Varian treatment system; Radiation: Adaptive stereotactic body radiotherapy; Drug: Androgen deprivation therapy

Interventions

Ethos Varian treatment system DEVICE

Device that will be used to administer radiotherapy

Adaptive stereotactic body radiotherapy (SBRT)

Adaptive stereotactic body radiotherapy RADIATION

Radiotherapy interruptions are acceptable as long as treatments are no more than 16 days apart.

Also known as: SBRT

Adaptive stereotactic body radiotherapy (SBRT)

Androgen deprivation therapy DRUG

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.

Also known as: ADT

Adaptive stereotactic body radiotherapy (SBRT)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Varian Medical Systems: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Androgen Antagonists

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Amit Bhatt, M.D., Ph.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2022
• First Posted: November 28, 2022
• Study Start: January 18, 2023
• Primary Completion: October 25, 2025
• Study Completion (Estimated): July 25, 2030
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)