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When given to men with recurrent prostate cancer, the investigators hypothesize that POMx is effective in slowing the rise of PSA as measured by PSA doubling time in men following initial therapy for prostate cancer. Further, the investigators believe that POMx will be shown to be safe and well tolerated.
The study will be an 18-month, prospective, multi-center, double-blind, dose finding study with subjects who have undergone definitive treatment (surgery, cryotherapy, radiation therapy or brachytherapy) for primary prostate tumor and have had documented rising PSA on a minimum of 3 time points each at least 1 month apart, higher than the reference value noted within 1 year of study entry.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 POMx capsule | Active Comparator | 1 POMx capsule daily |
|
| 3 POMx capsules daily | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3 POMx capsules | Drug | 3 POMx capsules daily |
| |
| 1 POMx capsule |
| Measure | Description | Time Frame |
|---|---|---|
| Prostate specific antigen doubling time (PSADT) | All subjects who have a baseline PSA value and at least 1 on study PSA value. The PSADT will be calculated as ln 2 (0.693)/ β (slope of the linear regression fit to ln PSA vs. time in months). | PSADT assessed at baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Incidence of adverse events Changes in vital signs | Safety and tolerability will be continuously assessed throughout the trial |
| Objective PSA response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Carducci, MD | Sidney Kimmel Cancer Center, Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University | Baltimore | Maryland | 21205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22689129 | Derived | Paller CJ, Ye X, Wozniak PJ, Gillespie BK, Sieber PR, Greengold RH, Stockton BR, Hertzman BL, Efros MD, Roper RP, Liker HR, Carducci MA. A randomized phase II study of pomegranate extract for men with rising PSA following initial therapy for localized prostate cancer. Prostate Cancer Prostatic Dis. 2013 Mar;16(1):50-5. doi: 10.1038/pcan.2012.20. Epub 2012 Jun 12. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 19, 2014 | |
| Unrelease | Yes |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 19, 2014 | Yes |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D009369 | Neoplasms |
| C563250 | Salivary Gland Adenoma, Pleomorphic |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D005832 | Genital Diseases, Male |
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| Drug |
1 POMx capsule daily |
|
OR: Decrease of 50% or more in the PSA PD: For subjects who achieved a >50% decline in PSA: An increase in PSA value by 50%. Changes in PSA below 5 ng/dL will not be considered assessable for progression.
For subjects whose PSA has not decreased by 50%: An increase in PSA value >50% of baseline. The PSA must have risen by at least 5 ng/dL.
OR any radiographic or symptomatic documentation of metastatic or recurrent disease.
SD: Does not qualify as objective response or progressive disease.
| PSA levels will be assessed every 3 months throughout the trial |
| D000091662 |
| Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |