Phase II Trial Of Combined High Dose Rate Brachytherapy And External Beam Radiotherapy For Adenocarcinoma Of The Prostate
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 129
- Locations
- 12
- Primary Endpoint
- Percentage of Participants With Late Grade 3-5 Genitourinary (GU) and Gastrointestinal (GI) Adverse Events (AE) at 18 Months
Study Overview
Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays and other sources to damage tumor cells. Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving radiation therapy in different ways may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving internal radiation therapy together with external-beam radiation therapy works in treating patients with stage II or stage III prostate cancer.
Detailed Description
OBJECTIVES:
Primary
- Determine the rate of late grade 3 or greater genitourinary and gastrointestinal toxicity after treatment with external beam radiotherapy and high-dose rate brachytherapy in patients with stage II or III adenocarcinoma of the prostate.
Secondary
- Determine acute grade 3 or greater genitourinary and gastrointestinal toxicity in patients treated with this regimen.
- Determine freedom from biochemical failure in patients treated with this regimen.
- Determine overall survival of patients treated with this regimen.
- Determine disease-specific survival of patients treated with this regimen.
- Determine clinical relapse (local and/or distant) in patients treated with this regimen.
- Develop a quality assurance process for high-dose rate prostate brachytherapy.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Histologically confirmed, adenocarcinoma of the prostate, clinical stage T1c-T3b, N0, M
- •Patient will have clinically negative nodes as established by imaging (pelvic computed tomography (CT), magnetic resonance imaging (MRI)).
- •The patient will be clinically M
- •Zubrod status 0-
- •No prior pelvic or prostate radiation or chemotherapy for prostate cancer; induction hormonal therapy beginning ≤ 120 days prior to registration is acceptable.
- •One of the following combinations of factors:
- •Clinical stage T1c-T2c, Gleason score 2-6 and prostate-specific antigen (PSA) >10 but ≤ 20 Clinical stage T3a-T3b, Gleason score 2-6 and PSA ≤ 20 Clinical stage T1c-T3b, Gleason score 7-10 and PSA ≤ 20
- •Patients must sign a study-specific consent form prior to registration.
Exclusion Criteria
- •Stage T4 disease.
- •Lymph node involvement (N1).
- •Evidence of distant metastases (M1).
- •Radical surgery for carcinoma of the prostate.
- •Previous hormonal therapy beginning > 120 days prior to registration.
- •Major medical or psychiatric illness which, in the investigator's opinion, would prevent completion of treatment and would interfere with follow-up.
- •Prior transurethral resection of the prostate (TURP).
- •Prior invasive malignancy(except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (For example, carcinoma in situ of the oral cavity or bladder are permissible).
- •Hip prosthesis.
Arms & Interventions
External Beam Radiotherapy and High Dose brachytherapy boost
Intervention: High Dose brachytherapy boost (Radiation)
External Beam Radiotherapy and High Dose brachytherapy boost
Intervention: External beam radiotherapy (Radiation)
Outcomes
Primary Outcomes
Percentage of Participants With Late Grade 3-5 Genitourinary (GU) and Gastrointestinal (GI) Adverse Events (AE) at 18 Months
Time Frame: From 9 to 18 months after start of study treatment
Adverse events (AE) were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE. "Late" is defined as occurring after 9 months from the start of study treatment. Because of the lead time of 9 months, the percentage at 18-months was estimated by the 9-month rate using the cumulative incidence method starting at the 10th month. Death was treated as a competing risk.
Secondary Outcomes
- Percentage of Participants Alive at 10 Years(From registration to 10 years)
- Percentage of Participants With Distant Failure at 10 Years(From registration to ten years)
- Number of Participants With Acute Grade 3-5 Genitourinary (GU) and Gastrointestinal (GI) Adverse Events (AE)(From treatment start to 9 months)
- Percentage of Participants With Biochemical Failure at 10 Years Using the Phoenix Definition(From registration to ten years)
- Percentage of Participants With Biochemical Failure at 10 Years Using American Society for Therapeutic Radiation and Oncology (ASTRO) Definition(From registration to ten years)
- Percentage of Participants With Death Due to Prostate Cancer at 10 Years(From registration to ten years)
- Percentage of Participants With Local Failure at 10 Years(From registration to ten years)