Proton-Based Stereotactic Ablative Body Radiotherapy for Prostate Cancer

NCT03159676 | Completed

• 3 other identifiers: 17-000680ROR1752NCI-2024-01752
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

Prostate cancer; Radiation therapy; Radiotherapy; Proton; Proton beam; Stereotactic ablative body radiotherapy; Stereotactic body radiotherapy; SABR; SBRT; Localized; Low risk; Intermediate risk

Outcome Measures

Primary Outcomes (1)

• Adverse Events

  Will be assessed by the number of late grade ≥3 Gastrointestinal and Renal and Urinary/Genitourinary adverse event incidents recorded at 24 months after SABR

  24 months

Secondary Outcomes (3)

• Biochemical (PSA) failure

  120 months

• Quality of life - EPIC

  Baseline; 120 months

• Overall survival

  120 months

Interventions

Proton beam RADIATION

Proton beam

Also known as: Radiation therapy, Radiotherapy, Stereotactic ablative body radiotherapy, Stereotactic body radiotherapy, SABR, SBRT

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult male patients with prostate cancer.

You may qualify if:

• Male, age ≥ 18 years.
• Histological confirmation of adenocarcinoma of prostatic origin.
• AJCC 7th edition clinical T1b-fdiabetes mellitus 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.

You may not qualify if:

• 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 or clotting factor inhibitor (e.g., rivaroxaban) 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).
• Inability to start radiation per protocol.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Proton Beam Therapy Clinical Trials

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Proton Therapy; Radiotherapy; Radiosurgery

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)

Heavy Ion Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Brad J. Stish, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 17, 2017
• First Posted: May 19, 2017
• Study Start: May 12, 2017
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 25, 2026

Record last verified: 2026-02

Locations

US (1)