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Details for trial 4P-06-4

Description:	Docetaxel (Taxotere) plus 6-Month Androgen Suppression and Radiation Therapy vs. 6-Month Androgen Suppression and Radiation Therapy for Patients with High-Risk Localized or Locally Advanced Prostate Cancer: A Randomized Controlled Trial.
Status:	Open
Randomized?	Yes

Researchers

Principal Investigator	Title
Parvesh Kumar	M.D.

Data Management

Name	Title
Carryl Du Bois	D.M.
Carryl Du Bois	D.M.

You may participate in this study if:

	Requirement
1	Histologic confirmation of prostate cancer.
2	Clinical category T2c, T3a, T3b, or T4 OR clinical category T1b to T2b, and one of the following: PSA >10 ng/ml or Gleason score =(4+3=7) or any minor tertiary grade of 5 or Gleason score =(4+3=7) with 50% or more cores positive or >2.0 ng/ml rise in PSA during the year prior to diagnosis.
3	PSA rise should be verified after the following criteria have been met: (a) abstinence from sexual activity/ejaculation 1 week prior; (b) no invasive procedures including but not limited to, colonoscopy, erMRI, cystoscopy, prostate needle biopsy, 2 weeks prior; (c) no horseback or bike riding 1 week prior; (d) genitourinary infection/inflammation ruled out 2 weeks prior. PSA should be repeated if any of the above conditions apply.
4	PSA should be obtained prior to initiation of hormonal therapy and within 3 months of study entry, except when a TURP has been performed which has falsely lowered the PSA. In this case, the PSA drawn immediately prior to TURP will be used as the baseline PSA, even if the PSA exceeds 3 months prior to entry.
5	Age at least 30 years old.
6	ECOG PS 0 or 1.
7	WBC >3.0; platelets >100,000; Hgb >8.0 (obtained within 1 month of study entry).
8	Total bilirubin < / = uln (except for Gilbert’s Syndrome); SGOT and SGPT obtained within 1 month of study entry within the range allowing for eligibility.
9	Creatinine <2.0.
10	Free and/or total serum testosterone obtained within 3 months of study entry.
11	Peripheral neuropathy < / = Gr 1.
12	Must agree to either abstain from sexual intercourse or use a medically acceptable form of contraception while on chemotherapy and for one month after completing chemotherapy.
13	Signed informed consent (including HIPAA authorization).

You may not participate in this study if:

1	Evidence of metastatic disease: (-) bone scan and (-) lymph node assessment (CT, MR) meaning pelvic LNs with a long axis of 1.5 cm or less obtained within 6 months of study entry and prior to initiation of hormonal therapy.
2	Prior history of malignancy that are <5 years disease-free (except for non-melanoma skin cancer, cancer confined to a colonic polyp, carcinoma in-situ of bladder) or a malignancy that would not likely impact a patient’s life expectancy with appropriate medical management.
3	Prior pelvic RT.
4	Unable to tolerate lying still for a 5-10 min RT because of mental illness or other physical ailment.
5	History of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80.

For further information on, or to sign up for this study, please contact the Clinical Investigation Support Office at (323) 865-0451 or the Principal Investigator noted above.