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

University of Southern California

Status

Active, not recruiting

Conditions

Stage III Prostate Adenocarcinoma

Stage II Prostate Adenocarcinoma

Stage IIB Prostate Cancer

Treatments

Radiation: Stereotactic Body Radiation Therapy

Other: Laboratory Biomarker Analysis

Other: Quality-of-Life Assessment

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT02446366

4P-14-8 (Other Identifier)

P30CA014089 (U.S. NIH Grant/Contract)

NCI-2015-00296 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

PRIMARY OBJECTIVES:

I. To determine maximum tolerated dose-per-fraction for SBRT to the prostate fossa following prostatectomy based on acute toxicity (< 90 days).

SECONDARY OBJECTIVES:

I. To describe the acute (< 90 days) toxicities and adverse events associated with hypofractionated SBRT when administered to the prostate bed in the post-prostatectomy setting.

II. To describe the late (> 90 days from treatment) toxicities and adverse events associated with hypofractionated SBRT when administered to the prostate bed in the post-prostatectomy setting.

TERTIARY OBJECTIVES:

I. To describe the patient-reported toxicity/quality of life (QOL) following hypofractionated SBRT treatment.

OUTLINE: This is a dose-escalation study.

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

After completion of study treatment, patients are followed up at 2, 6, and 13 weeks and then at 6, 9, 12, 18, 24, 30 and 36 months.

Enrollment

24 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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