Prostate Cancer Clinical Trial
Official title:
Proton-Based Stereotactic Ablative Body Radiotherapy (SABR) for Select Patients With Clinically Localized Prostate Cancer.
Verified date | July 2023 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Stereotactic ablative body radiotherapy (SABR), or stereotactic body radiotherapy (SBRT), is a specialized form of radiotherapy used to treat prostate cancer with five treatments over two weeks, compared with a conventional eight-week or longer treatment course. The purpose of this trial is to investigate the effect that proton-based SABR has on quality-of-life in patients with localized prostate cancer. The evaluation and treatment will otherwise follow standard of care, and is not considered investigational.
Status | Active, not recruiting |
Enrollment | 150 |
Est. completion date | June 2029 |
Est. primary completion date | June 2029 |
Accepts healthy volunteers | |
Gender | Male |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Male, age = 18 years. - Histological confirmation of adenocarcinoma of prostatic origin. - AJCC 7th edition clinical T1b-T2b. - AJCC clinical staging rules do not include findings from biopsy or imaging. - Gleason score =7 (International Society of Urological Pathologists grades 1-3). - Serum prostate-specific antigen =20 ng/mL. - Prostate-specific antigen <10 ng/mL, if dutasteride within last 90 days or finasteride within last 30 days. - Zubrod performance score 0-1. - Prostate volume <75-cc, determined by ultrasound, computed tomography or magnetic resonance imaging (modality with lesser volume is acceptable). - If neoadjuvant-concurrent androgen suppression is used, the prostate volume after the start of androgen suppression may be used. - American Urological Association voiding symptom index =15. - Ability to complete questionnaire(s) by themselves or with assistance. - Participation in a patient-reported outcomes survey program, inclusive of the Expanded Prostate Index Composite and CTCAE instruments. - Ability to provide informed written consent. Exclusion Criteria: - Radiological- or pathologically-confirmed seminal vesicle invasion, lymph node involvement, or distant metastatic disease. - Radiological- or biopsy-confirmed extraprostatic tumor extension without AJCC 7th edition clinical T3a classification remain eligible. - Prior or anticipated external radiotherapy or brachytherapy, transurethral resection of the prostate, prostatic cryoablation/focused ultrasound/laser therapy, prostatectomy, or prostatic enucleation. - Prior bilateral orchiectomy, planned long-term (>6 months duration) androgen suppression or peripheral androgen blockade, or chemotherapy or immunotherapy for prostate cancer. - Prior hemi- or total hip arthroplasty. - Diabetes mellitus associated with vascular ulcers or wound healing problems, ulcerative colitis, connective tissue disorder, or chronic (=120 days) warfarin use planned. - Co-morbid severe concurrent disease which, in the judgment of the investigator, would result in life expectancy <5 years. - Patients with a left cardiac ventricular assist device are ineligible. - Patients with an implanted medical electronic device (e.g., cardiac pacemaker) remain eligible if device monitoring complies with standard of practice (e.g., Cardiology and Medical Physics evaluation, function checks and during-treatment monitoring). - Immunocompromised due to HIV positive state. - Medical or psychiatric conditions that preclude informed decision-making or adherence. - Prior registration to an Institutional Review Board-approved therapeutic research study that includes proton beam therapy or photon-based radiotherapy (e.g., randomization to proton beam therapy vs. photon-based radiotherapy). |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic in Rochester | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of late grade =3 Gastrointestinal and Renal and Urinary/Genitourinary adverse events at 24 months after SABR | 24 months | ||
Secondary | Biochemical (PSA) failure | 120 months | ||
Secondary | Quality of life | Patient-reported questionnaire | 60 months | |
Secondary | Overall survival | 120 months |
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