Phase 3
N=588
Interstitial Brachytherapy With or Without External-Beam Radiation Therapy in Treating Patients With Prostate Cancer
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00063882 ↗Enrolled (actual)
588
Serious AEs
16.3%
Results posted
Oct 2019
Primary outcome: Primary: 5-Year Freedom From Progression Rate — 85.5; 83.1 percentage of participants — p=0.21
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Brachytherapy (100/110) (Radiation); Brachytherapy (125/145) (Radiation); External Beam Radiation Therapy (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Radiation Therapy Oncology Group
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 5-Year Freedom From Progression Rate |
85.5; 83.1 | 0.21 |
| SECONDARY Biochemical Failure Rate (Protocol Definition) |
10.5; 10.5 | 0.95 |
| SECONDARY Biochemical Failure (Phoenix Definition) |
8.0; 8.1 | 0.97 |
| SECONDARY Prostate Cancer Death |
0.4; 1.1 | 0.77 |
| SECONDARY Local Failure |
1.5; 1.1 | 0.99 |
| SECONDARY Distant Metastases |
2.9; 2.1 | 0.81 |
| SECONDARY Overall Survival |
95.3; 93.2 | 0.22 |
| SECONDARY Percentage of Patients With Acute Grade 2+ and Grade 3+ Toxicities [Genitourinary (GU), Gastrointestinal (GI), and Overall] |
24.1; 21.9; 27.7; 26.4; 6.0; 5.6 | 0.53 |
| SECONDARY Time to Late Grade 3+ Toxicities [Genitourinary (GU), Gastrointestinal (GI), and Overall] |
7.9; 3.8; 10.4; 6.6 | 0.01 sig |
| SECONDARY Change in Expanded Prostate Cancer Index Composite (EPIC) From Baseline to 4 Months |
-20.1; -14.1; -10.3; -8.7; -23.6; -15.9 | <0.0001 sig |
| SECONDARY Change in Expanded Prostate Cancer Index Composite (EPIC) From Baseline to 24 Months |
-11.2; -5.6; -7.6; -6.3; -11.9; -4.8 | 0.0002 sig |
| SECONDARY Change in Total American Urological Association Symptom Index (AUA-SI) Score From Baseline to 4 Months |
10.12; 7.77 | — |
| SECONDARY Change in Total American Urological Association Symptom Index (AUA-SI) Score From Baseline to 24 Months |
4.54; 2.37 | — |
| SECONDARY Change in European Quality of Life-5 Domains (EQ-5D) From Baseline to 4 Months |
-2.71; -0.44; -0.01; -0.01 | — |
| SECONDARY Change in European Quality of Life-5 Domains (EQ-5D) From Baseline to 24 Months |
-0.28; -0.57; -0.02; -0.01 | — |
Summary
RATIONALE: Radiation therapy uses high-energy x-rays and other sources to damage tumor cells. Interstitial brachytherapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Combining interstitial brachytherapy with external-beam radiation therapy may kill more tumor cells. It is not yet known whether interstitial brachytherapy is more effective with or without external-beam radiation therapy in treating prostate cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of interstitial brachytherapy with or without external-beam radiation therapy in treating patients who have prostate cancer.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the prostate
- T1c-T2b, N0, M0
- Intermediate-risk disease, as defined by 1 of the following:
- Gleason score < 7 AND prostate-specific antigen (PSA) 10-20 ng/mL
- Gleason score 7 AND PSA < 10 ng/mL
- No evidence of distant metastases
- Prostate volume ≤ 60 cc by transrectal ultrasonography
- American Urological Association voiding symptom score no greater than 15 (alpha blockers allowed)
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Zubrod 0-1
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Other
- Patients must use effective contraception
- No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ at any other site
- No major medical or psychiatric illness that would preclude study therapy
- No hip prosthesis
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior chemotherapy
Endocrine therapy
- Prior neoadjuvant hormonal therapy allowed provided the following are true:
- Therapy was initiated within 2-6 months of study enrollment
- Therapy was no more than 6 months in duration
- Use of 5-alpha reductase inhibitors (e.g., finasteride) is discontinued before registration
- No concurrent hormonal therapy
Radiotherapy
- No prior pelvic radiotherapy
Surgery
- No prior radical surgery for prostate cancer
- No prior transurethral resection of the prostate
- No prior cryosurgery
Other
- No prior transurethral needle ablation of the prostate
- No prior transurethral microwave thermotherapy of the prostate
Data sourced from ClinicalTrials.gov (NCT00063882). 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.