Testing Shorter Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients With High Risk Prostate Cancer

Conditions

• Prostate Adenocarcinoma
• Stage III Prostate Cancer AJCC v8
• Stage IVA Prostate Cancer AJCC v8

Eligibility Criteria

Sex

MALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Undergo blood and urine sample collection
• Bone Scan — PROCEDURE
  Undergo bone scan
• Computed Tomography — PROCEDURE
  Undergo CT or PET/CT
• External Beam Radiation Therapy — RADIATION
  Undergo EBRT
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Positron Emission Tomography — PROCEDURE
  Undergo PET/CT
• Quality-of-Life Assessment — OTHER
  Ancillary studies
• Questionnaire Administration — OTHER
  Ancillary studies
• Stereotactic Body Radiation Therapy — RADIATION
  Undergo SBRT

Study Details

This phase III trial compares stereotactic body radiation therapy (SBRT), (five treatments over two weeks using a higher dose per treatment) to usual radiation therapy (20 to 45 treatments over 4 to 9 weeks) for the treatment of high-risk prostate cancer. SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period of time. This trial is evaluating if shorter duration radiation prevents cancer from coming back as well as the usual radiation treatment.

Key Dates

Start date

Dec 14, 2023

Status verified

Apr 2026

Primary completion

Mar 31, 2036

Completion

Mar 31, 2036

Study Design

Enrollment

1,209 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm I (SBRT)
  Patients undergo SBRT for a total of 5 treatments over 2 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo bone scan and/or CT, MRI, or PET/CT during screening and CT and/or MRI on study. Additionally, patients may optionally undergo blood and urine sample collection on study.
• Active Comparator: Arm II (EBRT)
  Patients undergo EBRT for 20 to 45 treatments over 4 to 9 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo bone scan and/or CT, MRI, or PET/CT during screening and CT and/or MRI on study. Additionally, patients may optionally undergo blood and urine sample collection on study.

Primary Outcome Measure

Metastasis-free survival (MFS) [ Time Frame: From randomization to the date of distant metastasis, or death from any cause, assessed up to 15 years ]

Locations (388)

Find similar trials in Birmingham, AL

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