Clinical Trials Logo

Clinical Trial Summary

RATIONALE: Radical prostatectomy is surgery to remove the entire prostate. Radiation therapy uses high-energy x-rays or other types of radiation to kill tumor cells. Sometimes the tumor may not need treatment until it progresses. In this case, active surveillance may be sufficient. It is not yet known which treatment regimen is more effective for localized prostate cancer.

PURPOSE: This randomized phase III trial is studying active surveillance to see how well it works compared with radical prostatectomy or radiation therapy in treating patients with localized prostate cancer.


Clinical Trial Description

OBJECTIVES:

- To assess survival of patients with localized prostate cancer at 10 years and 15 years after treatment.

- To investigate 5-year survival, disease progression (i.e., biochemical and clinical), treatment complications, and lower urinary tract symptoms in these patients.

- To investigate the psychosocial impact of case-finding and treatment on these patients, including generic health status, quality of life, and sexual function.

- To estimate the resource use and costs of case-finding, treatment, and follow-up.

- To compare costs and outcomes of treatment in terms of survival and health-related quality of life.

- To collect samples suitable for basic science research (ProMPT study).

OUTLINE: This is a multicenter study. Patients are stratified by age (50-55 vs 56-59 vs 60-65 vs 66-69 years), Gleason score (2-4 vs 5-7 vs 8-10), and average result of Prostate Check Clinic and first biopsy prostate-specific antigen (PSA) tests (< 6 vs 6-9.9 vs ≥ 10 ng/mL). Patients are either randomized to or select 1 of 3 treatment arms.

- Arm I (active monitoring): Patients undergo active monitoring of their disease. Patients are seen by the research nurse 3 months after randomization to fine disease management plan. As part of this process, patients, together with the urologist or research nurse, develop a management plan that includes repeat PSA testing (every 3 months in the first year and then every 6 months thereafter) to detect biochemical progression. Patients also undergo an annual review appointment with an opportunity for digital rectal examination, if indicated (e.g., rise in PSA or new symptoms). PSA levels are monitored and tests repeated as needed. Additional review appointment is arranged with the study urologist for confirmed rising PSA level, apparent symptoms of spreading disease, or concern about the PSA levels. At the review appointment, the study urologist discusses issues raised and current options, including remaining on active monitoring, undergoing re-staging of the cancer, or receiving other treatments, as appropriate.

- Arm II (radical prostatectomy): Patients undergo radical prostatectomy (RP) within 2-12 weeks after study entry. Patients undergo RP and pelvic lymphadenectomy with or without frozen section biopsy of the pelvic lymph nodes prior to prostatectomy. Patients with positive surgical margins may be recommended for adjuvant treatment at the surgeon's discretion.

- Arm III (radical conformal radiotherapy): Patients undergo 3-dimensional conformal radiotherapy for 7.4 weeks (37 fractions). Patients receive neoadjuvant androgen-deprivation therapy comprising luteinizing hormone-releasing hormone (LHRH) agonists once every 4 weeks, beginning prior to the start of radiotherapy and continuing for at least 3-6 months (at least until completion of radiotherapy). Patients also receive cyproterone acetate or equivalent alternative beginning 1 week prior to the first LHRH agonist injection and continuing for at least 3 weeks.

After completion of surgery or radiotherapy, patients are followed according to National Health Service (UK) guidelines every 6-12 months.

All patients complete questionnaires at baseline and periodically during study to provide socio-demographic information (e.g., age, socio-economic status, and ethnicity), as well as clinical information on past or current urinary symptoms, previous PSA tests, anxiety and depression, sexual function, general health status, treatment-related quality of life, and environmental exposures. Resource use and cost-utility analysis is also performed. ;


Study Design

Allocation: Randomized, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00632983
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Active, not recruiting
Phase Phase 3
Start date June 2001

See also
  Status Clinical Trial Phase
Recruiting NCT05540392 - An Acupuncture Study for Prostate Cancer Survivors With Urinary Issues Phase 1/Phase 2
Recruiting NCT05613023 - A Trial of 5 Fraction Prostate SBRT Versus 5 Fraction Prostate and Pelvic Nodal SBRT Phase 3
Recruiting NCT05156424 - A Comparison of Aerobic and Resistance Exercise to Counteract Treatment Side Effects in Men With Prostate Cancer Phase 1/Phase 2
Completed NCT03177759 - Living With Prostate Cancer (LPC)
Completed NCT01331083 - A Phase II Study of PX-866 in Patients With Recurrent or Metastatic Castration Resistant Prostate Cancer Phase 2
Recruiting NCT05540782 - A Study of Cognitive Health in Survivors of Prostate Cancer
Active, not recruiting NCT04742361 - Efficacy of [18F]PSMA-1007 PET/CT in Patients With Biochemial Recurrent Prostate Cancer Phase 3
Completed NCT04400656 - PROState Pathway Embedded Comparative Trial
Completed NCT02282644 - Individual Phenotype Analysis in Patients With Castration-Resistant Prostate Cancer With CellSearch® and Flow Cytometry N/A
Recruiting NCT06305832 - Salvage Radiotherapy Combined With Androgen Deprivation Therapy (ADT) With or Without Rezvilutamide in the Treatment of Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer Phase 2
Recruiting NCT06037954 - A Study of Mental Health Care in People With Cancer N/A
Recruiting NCT05761093 - Patient and Physician Benefit/ Risk Preferences for Treatment of mPC in Hong Kong: a Discrete Choice Experiment
Completed NCT04838626 - Study of Diagnostic Performance of [18F]CTT1057 for PSMA-positive Tumors Detection Phase 2/Phase 3
Recruiting NCT03101176 - Multiparametric Ultrasound Imaging in Prostate Cancer N/A
Completed NCT03290417 - Correlative Analysis of the Genomics of Vitamin D and Omega-3 Fatty Acid Intake in Prostate Cancer N/A
Completed NCT00341939 - Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
Completed NCT01497925 - Ph 1 Trial of ADI-PEG 20 Plus Docetaxel in Solid Tumors With Emphasis on Prostate Cancer and Non-Small Cell Lung Cancer Phase 1
Recruiting NCT03679819 - Single-center Trial for the Validation of High-resolution Transrectal Ultrasound (Exact Imaging Scanner ExactVu) for the Detection of Prostate Cancer
Completed NCT03554317 - COMbination of Bipolar Androgen Therapy and Nivolumab Phase 2
Completed NCT03271502 - Effect of Anesthesia on Optic Nerve Sheath Diameter in Patients Undergoing Robot-assisted Laparoscopic Prostatectomy N/A