MDACC Study Summary 2006-0220

Study Summary
No. 2006-0220:.......Prostate......Curtis A. Pettaway......Urology

Study Summary Title



Study Summary Number:	2006-0220

Study Title:	A Randomized, Double-Blind, Placebo-Controlled Study of the Effects of Pomegranate Extract on Rising Prostate-Specific Antigen Levels in Men Following Primary Therapy for Prostate Cancer

Physician

New Patient Referral



Name:	Curtis A. Pettaway	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Urology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-3250 Contact us about clinical trials

General Information



Disease Group:	Prostate	Supported By:	N/A

Phase of Study:	N/A	Return Visit:	Subjects will return for clinical and laboratory evaluation every 13 weeks for a minimum of 1 year or until disease progression. Each participant will receive reimbursement or financial assistance for travel expenses.

Treatment Agents:	pomegranate extract	Home Care:	Subjects will drink 8 ounces of pomegranate juice, pomegranate liquid extract or placebo daily for 52 weeks. Study product will be shipped to them weekly. Patients will also complete a diary to report the consumption of the product.

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	No hospital stay is required for this study.


Description/ Intervention:	The goal of this clinical research study is to compare the ability of pomegranate liquid extract to placebo in potentially lowering PSA levels or stopping PSA levels from increasing in patients who have been treated for prostate cancer.

Study Objectives / Outcomes

Primary Objective:

To compare the effects of daily consumption of pomegranate liquid extract, and placebo on end-of-treatment (52 weeks) prostate-specific antigen (PSA) doubling time in male subjects who have rising serum PSA levels after primary therapy for localized prostate cancer.

Secondary Objectives:

1. To determine the effect of the pomegranate treatments on the change in serum PSA doubling time from baseline to end-of-treatment.
2. To evaluate the effects of the pomegranate treatments on changes in the health-related quality of life (QOL)
3. To determine the time to tumor recurrence
4. To assess the tolerability and toxicity of the pomegranate treatments
5. To determine the effect of the pomegranate treatments on response rates for positive serum PSA doubling times and for declining post-treatment serum PSA levels (negative doubling times)

Primary Outcome Variable
The primary outcome variable will be the mean serum PSA doubling time at end-of-treatment.

Secondary Outcome Variables
The secondary outcome variables include:

1. Measures of tolerability (adverse events) and toxicity (clinical chemistries, etc.).
2. Response rates in positive and negative serum PSA doubling times with a clinically significant positive doubling time is defined as >150% of baseline.
3. Overall efficacy responses categorized as,

Objective Response

(OR

Defined as a decrease of 50% or more in the serum PSA from baseline level;

Progressive Disease (PD)

Defined as either: a >/=100% increase in serum PSA (with a minimum value of 2.0 ng/mL) from baseline level, or confirmed metastatic or recurrent disease; and

Stable Disease (SD)

Does not qualify as objective response or progressive disease.

4. RAND 36-item Health Survey to assess QOL
5. Biomarker occurrences may be evaluated.

Study Status Information



Study Activation / Registration Date:	12/07/2006

IRB Review and Approval Date:	06/21/2006

Study Type:	Phase Iii

Recruitment Status:	Closed

Projected Accrual:	200

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Histologically confirmed adenocarcinoma of the prostate

2) Status post surgery, cryotherapy, or radiation therapy for the primary turmor

3) Documented rising serum PSA, including at least one of the following: absolute level of serum PSA >0.2 ng.mL following surgery; absolute level of serum PSA >1.0 ng/mL following radiation or cryotherapy; absolute level of serum PSA >/= 0.4 ng/mL for patients treated with multiple treatment modalities (e.g., surgery + radiation, radiation + cryotherapy, etc.) For the above PSA criteria, there must be 3 rising serum PSA time points over a minimum of 6 months above the minimum nadir achieved, and the entry serum PSA must be >/= 100% above the maximum nadir achieved

4) (Continued from 3) And must have both: 3 non-zero serum PSA measurements (including baseline) that are above the value reported after surgery, radiation cryotherapy or multiple treatment modalities; interval between seum PSA time points must be > 2 weeks

5) Performance status 0 or 1 on the ECOG scale

6) Minimum estimated life expectancy of 6 months

7) Subject must be eighteen years or older

8) Willingness and ability to sign an informed consent document

9) Agreement with complete abstinence from other commercially available pomegranate products during the course of the study

10) Use of dietary/herbal supplements (e.g., saw palmetto, selenium, etc) are acceptable provided the dose has been stable for at least 2 months prior to screening and the subject agrees not to change/stop during the course of the study

Exclusion Criteria:

1) Significant concomitant medical or psychiatric condition that, in the opinion of the investigator, would make the participant a poor protocol candidate

2) Hormonal therapy, with the exception of neoadjuvant androgen deprivation therapy (ADT) prior to or concurrent with primary therapy. Subjects who underwent neoadjuvant ADT must have a serum testosterone of >150 ng/mL at study entry

3) Concomitant or antecedent hormonal therapy for rising serum PSA after initial therapy of prostate cancer

4) Known allergy to pomegranate juice

5) Subjects unable or unwilling to comply with protocol requirements

6) Prior treatment with experimental drugs, high dose steroids, or with any drugs or therapy with the potential to impact prostate cancer or PSA within 6 months prior to the first dose of study product and for the duration of the study

7) Serum PSA > 7.0 ng/mL

8) Serum PSA doubling time </= 3 months or 24 > months

9) Evidence of metastatic disease on physical examination or on CT or bone scan

10) Use of finasteride, dutasteride at any point since primary therapy or during the study

11) Diabetes with a known HbA1c level > 7.0% during the past 3 months. Subjects with diabetes who have not had their HbA1c level measured during the last 3 months will have it tested at visit 1

12) Clinically significant abnormal laboratory value > 2X the upper limit of normal (2XULN)

Links

Registration Number: NCT00413530
Study Information on Clinical Trials Registry (clinicaltrials.gov)