Overview

Active Surveillance, Radical Prostatectomy, or Radiation Therapy in Treating Patients With Localized Prostate Cancer

Status:
Unknown status
Trial end date:
0000-00-00
Target enrollment:
2050
Participant gender:
Male
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Oxford University Hospitals NHS Trust
Treatments:
Cyproterone
Cyproterone Acetate
Hormones
Last Updated:
2012-04-13
Criteria
DISEASE CHARACTERISTICS:

- Histologically confirmed prostate cancer

- Clinically localized disease

- Stage T1-T2, NX, M0 tumor

- Prostate-specific antigen (PSA) at the Prostate Check Clinic (PCC) in the range of
3.0-19.99 ng/mL

- No skeletal metastases by isotope bone scan (if PCC PSA 10-19.99 ng/mL or
Gleason score 8-10)

- Registered with a participating general practice on the date of the PCC

- Registration with another practice after study entry allowed

PATIENT CHARACTERISTICS:

- Life expectancy ≥ 10 years

- Fit for any of the three study treatments

- No concurrent or past malignancies other than a small treated skin cancer

- No serious cardiac or respiratory problems in the past 12 months, including any of
the following:

- Stroke

- Myocardial infarction

- Heart failure

- Chronic obstructive pulmonary disease

- Blood-borne infections allowed

PRIOR CONCURRENT THERAPY:

- No prior treatment for prostate malignancy

- No prior kidney dialysis or transplantation

- No bilateral hip replacement

- No previous entry to this study at a prior general practice