ACTIVE_NOT_RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official 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

Quick Facts

Study Start:2023-01-18

Study Completion:2030-07-25

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05628363

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Principal Investigator

Amit Bhatt, M.D., Ph.D.

PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Study Locations (Sites)

Washington University School of Medicine

Saint Louis, Missouri, 63110

United States

Collaborators and Investigators

Sponsor: Washington University School of Medicine

Amit Bhatt, M.D., Ph.D., PRINCIPAL_INVESTIGATOR, Washington University School of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-18

Study Completion Date2030-07-25

Study Record Updates

Study Start Date2023-01-18

Study Completion Date2030-07-25

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Prostate Cancer
Cancer of the Prostate