Phase 2
Completed N=92
Stereotactic Body Radiation Therapy in Treating Patients With Prostate Cancer
Source: ClinicalTrials.gov NCT00547339 ↗Enrolled (actual)
92
Serious AEs
0.0%
Results posted
Mar 2022
Primary outcomePrimary: Number of Participants With Dose Limiting Toxicity (Phase 1 Only) — 0; 0; 0; 0 participants
Summary
RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue.
PURPOSE: This phase I/II trial is studying the side effects and best dose of stereotactic body radiation therapy and to see how well it works in treating patients with prostate cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Dose Limiting Toxicity (Phase 1 Only) |
0; 0; 0; 0 | — |
| PRIMARY No. of Late Severe GU Toxicity (for Phase 2 Only) |
3; 1; 0 | — |
| PRIMARY No. of Late Severe GI Toxicity (for Phase 2 Only) |
4; 2; 0 | — |
| SECONDARY GU Toxicity (Only Phase 2) |
0; 0; 0 | — |
| SECONDARY GI Toxicity |
1; 1; 0 | — |
| SECONDARY Non-GU Toxicity |
— | — |
| SECONDARY Non-GI Toxicity |
— | — |
| SECONDARY Freedom From Biochemical Failure |
90.9; 100; 100; 100 | — |
| SECONDARY Overall Survival |
71.5; 85; 92; 98 | — |
| SECONDARY Disease Specific Survival |
100; 100; 100; 100 | — |
| SECONDARY Clinical Progression Including Local/Regional and Distant Relapse |
1; 0; 0; 0 | — |
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the prostate
- Stage T1a, T1b, T1c disease
- Stage T2a or T2b
- No direct evidence of regional or distant metastases
- No T2c, T3, or T4 tumors
- Gleason score ≤ 7
- Must meet the following criteria:
- Prostate-specific antigen (PSA) ≤ 20 ng/mL prior to starting hormonal therapy (if given) for patients with a Gleason score of 2-6
- PSA ≤ 15 ng/mL prior to starting hormonal therapy (if given) for patients with a Gleason score of 7
- Risk of pelvic lymph node involvement < 20% according to Roach formula
- Ultrasound-based volume estimation of the prostate gland ≤ 60 g
PATIENT CHARACTERISTICS:
- Zubrod performance status 0-2
- Fertile patients must use effective contraception
- No prior invasive malignancy, except for nonmelanoma skin cancer, unless disease-free for a minimum of 3 years (e.g., carcinoma in situ of the breast, oral cavity, or cervix are allowed)
- No significant urinary obstructive symptoms
- American Urological Association (AUA) score of ≤ 15 (alpha blockers allowed)
- No history of inflammatory colitis (including Crohn disease and ulcerative colitis)
- No history of significant psychiatric illness
- No severe, active comorbidity including any of the following:
- Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
- Transmural myocardial infarction within the past 6 months
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days prior to registration
- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
- Laboratory tests for liver function and coagulation parameters are not required for entry into this protocol
- AIDS (based on current CDC definition) or other immunocompromising condition
- HIV testing is not required for entry into this protocol
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- More than 9 months since prior hormonal therapy as neoadjuvant therapy or to downsize the prostate gland
- No prior pelvic radiotherapy
- No prior chemotherapy or surgery for prostate cancer
- No prior transurethral resection of the prostate (TURP) or cryotherapy to the prostate
- No plans for other concurrent post-treatment, adjuvant, antineoplastic therapy including surgery, cryotherapy, conventionally fractionated radiotherapy, hormonal therapy, or chemotherapy as part of the treatment for prostate cancer
Data sourced from ClinicalTrials.gov (NCT00547339). 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.