Stereotactic Body Radiation Therapy in Treating Patients With High-Risk Prostate Cancer Undergoing Surgery

Jonsson Comprehensive Cancer Center

Status

Completed

Conditions

Stage I Prostate Adenocarcinoma American Joint Committee on Cancer (AJCC) v7

Stage II Prostate Adenocarcinoma AJCC v7

Stage III Prostate Adenocarcinoma AJCC v7

Treatments

Radiation: Stereotactic Body Radiation Therapy

Other: Quality-of-Life Assessment

Other: Laboratory Biomarker Analysis

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT02830165

15-001580 (Other Identifier)

NCI-2016-00188 (Registry Identifier)

P50CA092131 (U.S. NIH Grant/Contract)

JCCCID608 (Other Identifier)

Details and patient eligibility

About

This phase I trial studies stereotactic body radiation therapy (SBRT) in treating patients with prostate cancer that is likely to come back or spread (high-risk) undergoing surgery. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Delivering radiotherapy before prostatectomy by SBRT is more convenient, conformal, and may spare normal tissues better than delivering radiotherapy after prostatectomy.

Full description

PRIMARY OBJECTIVES:

I. To assess feasibility of pre-operative stereotactic body radiotherapy (SBRT) in prostate cancer patients at high risk for recurrence after prostatectomy.

SECONDARY OBJECTIVES:

I. To assess safety and acute toxicity of SBRT followed by prostatectomy. This will be based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 and patient reported quality of life (Expanded Prostate Cancer Index Composite [EPIC] and International Prostate Symptom Score [IPSS] questionnaires).

II. Investigation of the radiobiology of SBRT in prostate cancer using resected prostate tumor tissue.

III. Evaluation of the nature of the immune response to prostate cancer generated by SBRT.

OUTLINE:

Patients undergo 3 fractions of SBRT over 1-2 weeks, 2-4 weeks prior to radical prostatectomy.

After completion of the study treatment, patients are followed up at 0 to 4 weeks, and every 3 months for 1 year.

Enrollment

11 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Histologically confirmed primary non-metastatic adenocarcinoma of the prostate
Patient desires and is medically fit to undergo prostatectomy
Karnofsky performance status (KPS) >= 70
Patients on androgen deprivation therapy (ADT) are allowed
For confirmation of high risk local failure status, patients will have any one of the following:
- Computed tomography (CT) or magnetic resonance imaging (MRI) demonstrating seminal vesicle invasion (SVI) or extraprostatic extension (EPE) within 1 year of enrollment into the study
- Pre-biopsy prostate-specific antigen (PSA) >= 20
- Gleason score 7-10 (Gleason 7 must be 4+3), presence of any Gleason 5 (even if a tertiary score) as determined at diagnostic biopsy
- Gleason score 7 and > 50% of biopsy cores positive for prostate cancer
- Clinical stage >= T3 (staging by imaging acceptable)
An image-guided biopsy (via Artemis Ultrasound with MRI co-registration) is encouraged but not required if not performed as standard of care biopsy

Exclusion criteria

Distant metastases, based upon:
- CT scan or MRI of the abdomen/pelvis or prostate specific membrane antigen (PSMA) positron emission tomography/computed tomography (PET/CT) within 120 days prior to registration and
- Bone scan or PSMA PET/CT within 120 days prior to registration; if the bone scan is suspicious, a plain x-ray and/or MRI must be obtained to rule out metastasis prior to registration
Patient is unable or unwilling to sign consent
Patient is considered low-risk and would not have received adjuvant radiation therapy (RT) outside of this study