Clinical trial · Interventional
Surgery Versus Internal Radiation in Treating Patients With Stage II Prostate Cancer
A Randomized Trial of Radical Prostatectomy Versus Brachytherapy for Patients With T1c or T2a N0 M0 Prostate Cancer
NCT00023686CI-TRIAL-00022846completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. It is not yet known whether surgery is more effective than internal radiation in treating prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with that of internal radiation in treating patients who have stage II prostate cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| radiation | Radiation | — | UNRESOLVED |
| surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- surgery
- description
- Patients undergo radical prostatectomy. Patients are followed every 6 months for 5 years and then annually thereafter.
- interventionNames
- Procedure: surgery
- type
- EXPERIMENTAL
- label
- radiation
- description
- Patients undergo brachytherapy with implanted iodine I 125 or palladium Pd 103 seeds. Patients are followed every 6 months for 5 years and then annually thereafter.
- interventionNames
- Radiation: radiation
Primary outcomes (1)
- measure
- overall survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Maximum age
- 75 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the prostate within the past 120 days * T1c-T2a, N0, M0 * No bilateral disease * Prostate-specific antigen (PSA) no greater than 10 ng/mL * In patients with prior neoadjuvant hormonal therapy (NHT), PSA must be less than 10 ng/mL prior to therapy * Gleason score no greater than 6 * Prostate gland less than 60 cc on transrectal ultrasound or with minimal pubic arch interference OR * Prostate gland 60 cc or greater prior to NHT allowed if prostate size has been reduced to less than 60 cc by NHT PATIENT CHARACTERISTICS: Age: * 75 and under Performance status: * ECOG 0-2 OR * Zubrod 0-2 Renal: * Creatinine no greater than 3 mg/dL Cardiovascular: * No significant cardiovascular disease * No New York Heart Association class III or IV heart disease Other: * No other malignancy within the past 5 years except effectively treated basal cell or squamous cell skin cancer or other malignancy at low risk for recurrence * No other condition that would preclude study PRIOR CONCURRENT THERAPY: Endocrine therapy: * See Disease Characteristics * At least 90 days since prior NHT * Duration of therapy no greater than 120 days * No concurrent NHT Radiotherapy: * No prior radiotherapy to pelvis Surgery: * No prior surgery for prostate cancer or benign disease, including: * Transurethral resection of the prostate * Transurethral resection of the bladder neck * Cryotherapy * Laser ablation * Microwave therapy
References
Publications (4)
- BACKGROUNDCrook J, Wallace K, Jewett M, et al.: Enhancing enrollment in difficult randomized trials: the profile of men accepting randomization to SPIRIT (surgical prostatectomy vs interstitial radiation). [Abstract] 2006 Prostate Cancer Symposium, February 24-26, 2006, San Francisco, CA. A-295, 2006.
- BACKGROUNDWallace K, Fleshner N, Jewett M, Basiuk J, Crook J. Impact of a multi-disciplinary patient education session on accrual to a difficult clinical trial: the Toronto experience with the surgical prostatectomy versus interstitial radiation intervention trial. J Clin Oncol. 2006 Sep 1;24(25):4158-62. doi: 10.1200/JCO.2006.06.3875. PMID 16943531
- RESULTCrook JM, Gomez-Iturriaga A, Wallace K, Ma C, Fung S, Alibhai S, Jewett M, Fleshner N. Comparison of health-related quality of life 5 years after SPIRIT: Surgical Prostatectomy Versus Interstitial Radiation Intervention Trial. J Clin Oncol. 2011 Feb 1;29(4):362-8. doi: 10.1200/JCO.2010.31.7305. Epub 2010 Dec 13. PMID 21149658
- RESULTCrook JM, Gomez-Iturriaga A, Wallace K, et al.: Comparison of health-related quality of life 5 years after SPIRIT (Surgical Prostatectomy [RP] versus Interstitial Radiation [BT] Intervention trial ACOSOG Z0070). [Abstract] 2010 Genitourinary Cancers Symposium, March 5-7, 2010, San Francisco, California. A-11, 2010.