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Stereotactic Body Radiation Therapy or Intensity-Modulated Radiation Therapy in Treating Patients with Stage IIA-B Prostate Cancer

Status
Active
Cancer Type
Prostate Cancer
Unknown Primary
Trial Phase
Phase III
Eligibility
18 Years and older, Male
Study Type
Treatment
NCT ID
NCT03367702
Protocol IDs
NRG-GU005 (primary)
NRG-GU005
NCI-2017-01398
Study Sponsor
NRG Oncology

Summary

This randomized phase III trial studies how well stereotactic body radiation therapy works compared to intensity-modulated radiation therapy in treating patients with stage IIA-B prostate cancer. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. 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. Stereotactic body radiation therapy may work better in treating patients with prostate cancer.

Objectives

PRIMARY OBJECTIVES:
I. To determine whether stereotactic body radiation therapy (SBRT) can be shown to be superior to hypofractionated intensity-modulated radiation therapy (IMRT) in terms of genitourinary (GU) and gastrointestinal (GI) toxicity by having fewer patients that experience a minimal important decline (MID) in urinary irritation/obstructive and bowel Health Related Quality of Life (HRQOL) as measured by Expanded Prostate Cancer Index Composite (EPIC)-26 at 24 months post completion of therapy.
II. To determine if SBRT (5 fractions of 7.25 Gy) is superior to hypofractionated IMRT (28 fractions of 2.5 Gy or 20 fractions of 3 Gy) as measured by disease free survival (DFS).

SECONDARY OBJECTIVES:
I. To determine whether SBRT can be shown to be superior to hypofractionated IMRT at 12 and 24 months post completion of therapy in terms of HRQOL by having fewer patients that experience a minimal important decline (MID) bowel (12 months only) sexual, hormonal, urinary irritation/obstructive (12 months only) and in urinary incontinence HRQOL as measured by EPIC-26.
II. To determine if SBRT (5 fractions of 7.25 Gy) is superior to hypofractionated IMRT (28 fractions of 2.5 Gy or 20 fractions of 3 Gy) as measured by biochemical failure, overall survival, local failure, prostate cancer specific survival, and distant metastases.
III. To determine the correspondence between the diagnostic magnetic resonance imaging (MRI) and biopsy.
IV. To determine if prostate imaging-reporting and data system (PIRADS)version (v)2.1 = 4/5 disease is prognostic for biochemical failure.

EXPLORATORY OBJECTIVES:
I. To determine whether a potentially more expensive therapy, SBRT, would be cost-effective than standard hypofractionated IMRT as measured by the European Quality of Life Five Dimension Five Level Scale Questionnaire (EQ-5D-5L).
II. To determine if disease characteristics captured on baseline and follow-up MRI can be used to predict which patients will respond to SBRT versus hypofractionated IMRT.
III. To validate autosegmentation tools for the prostate and tumors.
IV. Collect specimens for future translational research analyses.

OUTLINE: Patients are randomized into 1 of 2 arms.

ARM I: Patients undergo IMRT once daily for 5 fractions per week for 20 or 28 fractions over less than 32 business days.

ARM II: Patients undergo SBRT at least every other day for 2-3 fractions per week over less than 17 business days.

After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Eligibility

  1. Previously untreated (no local therapy such as surgery, radiation cryotherapy, high-intensity focused ultrasound [HIFU], etc.) localized adenocarcinoma of the prostate with the following clinical findings: * Clinical stage by digital rectal exam of either T1c or T2a/b (limited to one side of the gland); (American Joint Committee on Cancer [AJCC], version 7) or cT1a-c or 2a or 2b * Stages T1a-T1b are eligible if patient underwent transurethral prostatic resection (TURP), the patient must meet one of the following 3 criteria: 1) Gleason score must be Gleason 7(3+4) with a PSA < 20 ng/mL, or 2) Gleason 6 (3+3) with a PSA > 10 ng/mL and < 20 ng/mL; (AJCC, version 7), or 3) group grade 1 or 2 ** If patient is receiving a 5-alpha reductase inhibitor at the time of enrollment, the baseline PSA value may be double the initial value and the medication should be discontinued but a washout period is not required; to be eligible, a PSA drawn while still on the medicine must be: *** < 10 ng/mL if Gleason 7(3+4) (note this patient would be on stratification level 1 if PSA < 5 ng/mL and stratification level 2 if less than 10 ng/mL) **** Stratification level 1 if PSA < 5 ng/mL and stratification level 2 if less than 10 ng/mL *** > 5 ng/mL and less than 10 ng/mL for Gleason 6(3+3) (note this patient would be on stratification level 3) * The prostate volume must be < 70 cc as reported at time of biopsy or by separate measure with ultrasound or other imaging modalities including magnetic resonance imaging (MRI) or computed tomography (CT) scan * Patients in active surveillance who elect to be treated are eligible if they meet protocol requirements
  2. History and physical including a digital rectal exam 60 days prior to registration
  3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 60 days prior to registration
  4. MRI of the prostate and pelvis (compliant with PIRADSv2.1 guidelines) within 1 year prior to registration
  5. Bone scan as clinically indicated within 120 days prior to registration
  6. Charlson modified co-morbidity score =< 4 for patients under 60 and =< 5 for patients 60 and over 21 days prior to registration
  7. International prostate symptom score (IPSS) of < 15 21 days prior to registration
  8. The patient must provide study-specific informed consent prior to study entry
  9. Willingness and ability to complete the Expanded Prostate Cancer Index Composite (EPIC-26) questionnaire
  10. Completion of all items of the EPIC-26 which will be data entered at registration 60 days prior to registration
  11. Only English, Spanish, and French-speaking patients are eligible to participate as these are the only languages EPIC-26 has been validated in

Treatment Sites in Georgia

Emory Saint Joseph's Hospital


5665 Peachtree Dunwoody Road NE
Atlanta, GA 30342
www.emoryhealthcare.org

Emory University Hospital - Midtown


550 Peachtree Street NE
Atlanta, GA 30308
404-686-4411
www.emoryhealthcare.org

Grady Memorial Hospital


80 Jesse Hill Jr. Drive, SE
Atlanta, GA 30303
www.gradyhealth.org

Piedmont Fayette Hospital


1255 Highway 54 West
Fayetteville, GA 30214
404-851-2340
www.piedmont.org

Piedmont Hospital - Atlanta


1968 Peachtree Road, NW
Atlanta, GA 30309
www.piedmont.org

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
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