Clinical trial · Observational
Quality of Life in Men With High Risk Localized Prostate Cancer
Assessment of Quality of Life in Men With High Risk Localized Prostate Cancer Undergoing Neoadjuvant Investigational Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow accrual
Summary
Brief summary (as posted)
Primary Objectives: 1. To describe patient quality of life (QOL) related to bladder, bowel, and sexual function, as well as mental and physical health, in patients who received neoadjuvant investigational therapies prior to radical prostatectomy (RP) for high risk clinically localized prostate cancer (HRCLPC). 2. To identify medical and demographic variables that are related with quality of life, e.g., hormonal or non-hormonal neoadjuvant treatment, time since surgery, disease recurrence, subsequent treatment, age, ethnicity, and socioeconomic status. Secondary Objectives: 1\. To describe treatment satisfaction expressed by patients who have received neoadjuvant investigational therapies prior to radical prostatectomy for high risk clinically localized 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| QOL Questionnaire | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- QOL Questionnaire
- interventionNames
- Behavioral: QOL Questionnaire
Primary outcomes (1)
- measure
- Quality of life (QOL) variables related to bladder, bowel, and sexual function, as well as mental and physical health, in patients who received neoadjuvant investigational therapies prior to radical prostatectomy (RP) for HRCLPC.
- timeFrame
- 2 Years
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Prostate cancer patient who participated in one of the following neoadjuvant treatment trials: * DM96-140 - A Safety Study of TNP-470 Followed by Radical Prostatectomy for Patients with Locally Advanced Adenocarcinoma of the Prostate * DM97-095 - A Tolerance \& Efficacy Study of Adenoviral Vector Expressing Wild-type P53 (AD-P53) Preoperative Administration Intraprostatically in Patients with Locally Advanced Prostate Cancer Followed by a Radical Prostatectomy * ID00-089 - A Tolerance and Efficacy Trial of Preoperative Thalidomide Treatment Followed By Radical Retropubic Prostatectomy (RRP) In Select Patients With Locally Advanced Prostate Cancer * ID97-046 - Preoperative Chemotherapy Followed by Radical Prostatectomy for Patients with Locally Advanced Adenocarcinoma of the Prostate * ID99-061- A Randomized Trial of Preoperative Chemotherapy and Androgen Ablation Compared to Androgen Ablation Alone Followed by Radical Prostatectomy for Select Patients with Locally Advanced Adenocarcinoma of the Prostate The study will include those patients who completed preoperative therapy and radical prostatectomy. * Men over the age of 40 years. Exclusion Criteria: * Patients that did not undergo both preoperative therapy and a radical prostatectomy.
References
Publications (0)
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