Phase 2
Completed N=129
Radiation Therapy in Treating Patients With Stage II or Stage III Prostate Cancer
Source: ClinicalTrials.gov NCT00091390 ↗Enrolled (actual)
129
Serious AEs
42.6%
Results posted
Nov 2014
Primary outcomePrimary: Percentage of Participants With Late Grade 3-5 Genitourinary (GU) and Gastrointestinal (GI) Adverse Events (AE) at 18 Months — 2.56 percentage of participants — p=<0.0001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Late Grade 3-5 Genitourinary (GU) and Gastrointestinal (GI) Adverse Events (AE) at 18 Months |
2.56 | <0.0001 sig |
| SECONDARY Number of Participants With Acute Grade 3-5 Genitourinary (GU) and Gastrointestinal (GI) Adverse Events (AE) |
2.61 | — |
| SECONDARY Percentage of Participants With Biochemical Failure at 10 Years Using American Society for Therapeutic Radiation and Oncology (ASTRO) Definition |
14.7 | — |
| SECONDARY Percentage of Participants With Biochemical Failure at 10 Years Using the Phoenix Definition |
22.6 | — |
| SECONDARY Percentage of Participants Alive at 10 Years |
75.7 | — |
| SECONDARY Percentage of Participants With Death Due to Prostate Cancer at 10 Years |
6.4 | — |
| SECONDARY Percentage of Participants With Distant Failure at 10 Years |
7.7 | — |
| SECONDARY Percentage of Participants With Local Failure at 10 Years |
1.7 | — |
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed, adenocarcinoma of the prostate, clinical stage T1c-T3b, N0, M0.
- Patient will have clinically negative nodes as established by imaging (pelvic computed tomography (CT), magnetic resonance imaging (MRI)).
- The patient will be clinically M0.
- Zubrod status 0-1.
- 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.
Data sourced from ClinicalTrials.gov (NCT00091390). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.