Adaptive radiation therapy for high-risk prostate cancer
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
This study is testing a new type of radiation therapy for men with high-risk prostate cancer to see if it can safely target tumors while causing fewer side effects.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Washington University School of Medicine Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Saint Louis, Missouri) |
| Trial ID | NCT05628363 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and feasibility of whole-pelvis adaptive stereotactic body radiation therapy (SBRT) combined with a tumor boost to MR-detected lesions in patients with high-risk and unfavorable intermediate-risk prostate cancer. The study will utilize the Ethos Varian treatment system and assess the occurrence of significant genitourinary and gastrointestinal adverse events. The hypothesis is that less than 15% of participants will experience severe acute side effects from this innovative treatment approach.
Who should consider this trial
Good fit: Ideal candidates include men with pathologically confirmed high-risk or unfavorable intermediate-risk prostate cancer who have at least one MR-detectable lesion.
Not a fit: Patients with low-risk prostate cancer or those without detectable lesions on MRI may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective and targeted radiation therapy option for patients with high-risk prostate cancer.
How similar studies have performed: Other studies have shown promise with adaptive radiation therapy approaches, but this specific combination of techniques is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Saint Louis, Missouri
- Washington University School of Medicine — Saint Louis, Missouri, United States (Recruiting)
Study contacts
- Principal investigator: Amit Bhatt, M.D., Ph.D. — Washington University School of Medicine
- Study coordinator: Amit Bhatt, M.D., Ph.D.
- Email: amitb@wustl.edu
- Phone: 314-747-4236
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.