Clinical trial · Interventional
Surgery in Treating Patients With Prostate Cancer
The Role of Salvage Prostatectomy for Radiation Failure in Prostate Carcinoma: A Phase II Trial
NCT00002938CI-TRIAL-00022858completedPhase 2ClinicalTrials.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: Prostatectomy may be an effective treatment for prostate cancer that has not responded to radiation therapy. PURPOSE: This phase II trial is studying how well prostatectomy works in treating patients with recurrent or persistent prostate cancer that has not responded to radiation therapy.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| conventional surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Surgery
- description
- Salvage prostatectomy
- interventionNames
- Procedure: conventional surgery
Primary outcomes (1)
- measure
- Survival characteristics
- timeFrame
- pre treatment; q 3 mon for 2 years, then q 6 mon for 2 yrs, then q year
Secondary outcomes (1)
- measure
- QOL assessment
- timeFrame
- pre treatment; 3, 6, 12, 18, and 24 mon post treatment
- description
- Quality of life questionnaire
Eligibility
Eligibility (as posted)
- Sex
- Male
- Maximum age
- 75 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically proven recurrent or persistent prostate cancer * Prostate-specific antigen (PSA) no greater than 20 ng/mL * Must have been previously treated with at least 60 cGy of external beam radiotherapy or brachytherapy for clinical stages T1-2NXM0 with PSA no greater than 30 ng/mL * No metastatic disease at time of biopsy PATIENT CHARACTERISTICS: Age: * 75 and under Performance status: * CALGB (Zubrod) 0-1 Life expectancy: * At least 5-10 years Other: * No other "currently Temporarily closed" malignancy except nonmelanoma skin cancer * Patients are not considered to have a "currently Temporarily closed" malignancy if they have completed therapy and are considered to be at less than 30% risk of relapse PRIOR CONCURRENT THERAPY: Endocrine therapy: * At least 3 months since prior adjuvant hormonal therapy Radiotherapy: * See Disease Characteristics * At least 18 months since prior external beam or interstitial radiotherapy
References
Publications (1)
- RESULTSokoloff MH, Halabi S, Sanford B, et al.: Management of recurrent prostate cancer after radiotherapy: preliminary results of CALGB 9687, a contemporary salvage prostatectomy series. [Abstract] American Society of Clinical Oncology 2005 Prostate Cancer Symposium, 17-19 February 2005, Orlando, Florida. A-166, 2005.