Hypofractionated Stereotactic Body Radiation Therapy for Patients With Prostate Cancer That Was Removed by Surgery

NCT02446366 | Unknown DMC FDA Device

• 3 other identifiers: 4P-14-8NCI-2015-00296P30CA014089
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This phase I trial studies the side effects and the best dose of hypofractionated stereotactic body radiation therapy (SBRT) in treating patients with prostate cancer that was removed by surgery. Hypofractionated SBRT delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and may have fewer side effects than standard radiation therapy.

Conditions

Stage II Prostate Adenocarcinoma; Stage IIB Prostate Cancer; Stage III Prostate Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose-per-fraction based on acute toxicity assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 4.03

  Maximum tolerated dose (MTD) is defined as the highest dose tested in which none or only one patient experienced dose limiting toxicity (DLT) attributable to the radiation therapy when 12 patients were treated at that dose and are evaluable for toxicity and is one dose level below the lowest dose level tested where two or more patients experienced radiation associated DLT. All toxicities and side effects of all patients who start SBRT will be recorded and summarized.

  < 90 days

Secondary Outcomes (1)

• Incidence of adverse events assessed according to CTCAE v. 4.03

  Up to 36 months after completion of SBRT

Study Arms (1)

Treatment (hypofractionated SBRT)

EXPERIMENTAL

Patients undergo 5, 10, or 15 fractions of hypofractionated SBRT daily over 1-3 weeks.

Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment; Radiation: Stereotactic Body Radiation Therapy

Interventions

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (hypofractionated SBRT)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Treatment (hypofractionated SBRT)

Stereotactic Body Radiation Therapy RADIATION

Undergo hypofractionated SBRT

Also known as: SBRT

Treatment (hypofractionated SBRT)

Eligibility Criteria

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

You may qualify if:

• Adenocarcinoma of the prostate treated primarily with radical prostatectomy
• Any type of radical prostatectomy is permitted including retropubic, perineal, laparoscopic or robotically assisted; there is no time limit for the date of radical prostatectomy
• One of the following pathologic classifications
• T3N0 disease with or without a positive surgical margin or
• T2N0 disease with or without a positive surgical margin
• Those with T2N0 disease and a negative margin must have a detectable prostate-specific antigen (PSA) following radical prostatectomy or
• Must have had an undetectable PSA after prostatectomy and has since had a rise in post-operative PSA to 0.2 ng/mL or greater
• Zubrod performance status of 0 -1
• No distant metastases, based on the following workup within 60 days prior to registration
• Magnetic resonance imaging (MRI) of the pelvis
• Bone scan or sodium fluoride positron emission tomography (PET), that if suspicious has MRI or plain X-rays to rule out bone metastasis
• Patients can be on androgen deprivation therapy
• Ability to understand and willingness to sign a study-specific informed consent prior to study entry

You may not qualify if:

• N1 patients are ineligible, as are those with lymph node (LN) enlargement \> 1.5 cm by computed tomography (CT) or MRI of the pelvis, unless the LN is biopsy proven to be negative
• Gross residual disease in the prostate fossa appreciated wither on digital rectal examination (DRE) or on imaging, unless biopsy proven not to contain cancer
• Patients who were exposed to neoadjuvant chemotherapy or chemotherapy after prostatectomy
• Prior radiation of any kind to the prostate gland or pelvis
• Prior brachytherapy is not allowed
• History of inflammatory colitis or other active severe comorbidities
• Patients who are on immunosuppressant medication

Sponsors & Collaborators

• University of Southern California: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

USC Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Related Publications (1)

• Ballas LK, Luo C, Chung E, Kishan AU, Shuryak I, Quinn DI, Dorff T, Jhimlee S, Chiu R, Abreu A, Jennelle R, Aron M, Groshen S. Phase 1 Trial of SBRT to the Prostate Fossa After Prostatectomy. Int J Radiat Oncol Biol Phys. 2019 May 1;104(1):50-60. doi: 10.1016/j.ijrobp.2018.12.047. Epub 2018 Dec 31.

  PMID: 30605751 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

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)

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

Study Officials

• Leslie Ballas

  University of Southern California

  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: April 10, 2015
• First Posted: May 18, 2015
• Study Start: May 12, 2015
• Primary Completion: February 26, 2020
• Study Completion: February 12, 2023
• Last Updated: December 12, 2022

Record last verified: 2022-12

Locations

US (1)