Trial NCT00756665
Prostate Active Surveillance Study
- Phase
- Not given
- Sponsor
- University of Washington
- Conditions
- Prostatic Neoplasms
- Ages
- 21+ years
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
Inclusion Criteria:
* Histologically confirmed adenocarcinoma of the prostate from a prostate biopsy.
* Clinically localized prostate cancer: T1-2, NX or N0, MX or M0.
* No previous treatment for prostate cancer (including hormonal therapy, radiation therapy, surgery, or chemotherapy).
* ECOG Performance Status 0 or 1.Performance status
* Patient has elected Active Surveillance as preferred management plan for prostate cancer.
* Patient consent has been obtained according to local Institutional Review Board for acquisition of research specimens.
* Patient is accessible and compliant for follow-up.
* Prostate cancer diagnosis cannot be more than 3 years prior to baseline visit date.
* No more than two prostate biopsies including the initial biopsy in which cancer was diagnosed.
* If cancer diagnosis is more than one year before enrollment, there must be two prostate biopsies including the initial biopsy in which cancer was diagnosed and a subsequent biopsy. The subsequent biopsy may occur on the same day as the baseline visit.
* Biopsies must have at least 10 cores.
Exclusion Criteria:
* Unwillingness or inability to undergo serial prostate biopsy.
* History of other malignancies, except: adequately treated non-melanoma skin cancer or adequately treated superficial bladder cancer (Ta) or other solid tumors curatively treated with no evidence of disease for > 5 years.Prior malignancy
Restrictions found (2)
- Performance statusOutrightinclusion
ECOG 0 or 1
Show in the text - Prior malignancyOutrightexclusion
other malignancies excluded except treated non-melanoma skin cancer, Ta bladder cancer, or solid tumors NED > 5 years
Show in the text
Recruiting in Massachusetts
- Beth Israel Deaconess Medical Center/Harvard Medical School · Boston, Suffolk County