Table 1.
Selected Completed and Ongoing Clinical Trials for Patients With PSA-Recurrent Prostate Cancer After Local Therapy
| Trials of ADT Plus Additional Experimental Agents | Findings | Phase/Identifier |
|---|---|---|
| Sequencing of sipuleucel-T and ADT in men with non- metastatic biochemically-recurrent prostate cancer |
Ongoing | II - NCT01431391 |
| ADT with or without bevacizumab for PSA-recurrent prostate cancer after definitive local therapy |
Ongoing | II - NCT00776594 |
| Oral thalidomide versus placebo in addition to ADT in patients with stage D0 androgen-dependent prostate cancer |
Trend toward increased PSADT with thalidomide versus placebo45 |
III - NCT00004635 |
| Bicalutamide with or without MK-2206 (Akt inhibitor) in patients with previously treated prostate cancer |
Ongoing | II - NCT01251861 |
| Bicalutamide and RO4929097 in patients with previously treated prostate cancer |
Ongoing | II - NCT01200810 |
| Tremelimumab (CTLA4-blocking antibody) plus short-term bicalutamide in patients with stage D0 prostate cancer |
Significant prolongation of PSADT was observed in 18% of patients46 |
I - NCT00702923 |
| Trials of Other Nonhormonal Pharmaceuticals | Findings | Phase/Identifier |
| Celecoxib versus placebo in patients with BCR prostate cancer | Despite significant improvements in PSA velocity with celecoxib, study terminated early due to cardiovascular concerns47 |
II - NCT00136487 |
| Celecoxib in treating patients with relapsed prostate cancer following radiation therapy or radical prostatectomy |
Significant slowing in PSADT with celecoxib at 3, 6, and 12 months48 |
II - NCT00073970 |
| Rosiglitazone versus placebo for androgen-dependent recurrent prostate cancer |
No increase in PSADT or time-to- PSA-progression with rosiglitazone vs placebo49 |
II - NCT00182052 |
| Disulfiram in patients with recurrent prostate cancer as evidenced by a rising PSA |
Ongoing | II - NCT01118741 |
| Valproic acid in treating patients with progressive nonmeta- static prostate cancer |
Ongoing | II - NCT00670046 |
| Atorvastatin and celecoxib for patients with rising PSA levels after local therapy for prostate cancer |
Ongoing | II - NCT01220973 |
| Imatinib in prostate cancer patients with rising PSA following radical prostatectomy |
Median PSA did not decrease significantly and trial was halted early due to toxicities50 |
II - NCT01316458 |
| Calcitriol in treating patients with a rising PSA level following local therapy for prostate cancer |
Significant but small increase in PSADT from baseline (7.8 to 10.3 months)51 |
II - NCT00004043 |
| Calcifediol for patients with PSA-recurrent prostate cancer | 80% of patients had increases in PSADT52 |
II - NCT00018538 |
| Study of 2 different doses of lenalidomide in biochemically- relapsed prostate cancer |
Significant dose-dependent improve- ment in PSA slope53 |
I/II - NCT00348595 |
| Hydroxychloroquine in treating patients with rising PSA levels after local therapy for prostate cancer |
Ongoing | II - NCT00726596 |
| Lapatinib for patients with PSA-recurrent prostate cancer | No PSA responses but significant reduc- tion in mean PSA slope (log PSA/mo)54 |
II - NCT00103194 |
| Sulforaphane in treating patients with PSA-recurrent pros- tate cancer |
Ongoing | II - NCT01228084 |
| pTVG-HP (prostatic acid phosphatase DNA-plasmid vaccine) in patients with recurrent prostate cancer |
Significant but small increase in PSADT from baseline (6.5 to 8.5 months)55 |
I - NCT00582140 |
| Fenretinide in patients with BCR, hormone-naïve prostate cancer |
Did not meet primary endpoint of PSA response56 |
II - NCT00080899 |
| Trials of Other Nonhormonal Pharmaceuticals | Findings | Phase/Identifier |
| Sipuleucel-T versus placebo for the treatment of hormone- sensitive PSA-recurrent prostate cancer |
Sipuleucel-T patients had a 48% increase in PSADT 57 |
III - NCT00779402 |
| Metformin with simvastatin for patients with BCR prostate carcinoma |
Ongoing | II - NCT01561482 |
| ATN-224 (copper/zinc superoxide dismutase inhibitor) at 2 dose levels in patients with PSA-recurrent prostate cancer |
Significant mean PSA slope decrease (P=.006) and mean PSADT increase (P=.032) in the low-dose arm only 58 |
II - NCT00405574 |
| Trials of Nonhormonal Natural Products | Findings | Phase/Identifier |
| Pomegranate juice in treating patients with PSA-recurrent pros- tate cancer (single-arm study) |
Significant increase in median PSADT from baseline (11.5–28.7 months) 38 |
II - NCT00060086 |
| POMx capsules (pomegranate extract) in patients with PSA- recurrent prostate cancer: 18-month dose-finding study |
Significant 6-month PSADT improvement from baseline, no dose effect 42 |
II - NCT01220817 |
| Pomegranate extract versus placebo in treating patients with rising PSA after surgery or radiation therapy |
Ongoing | II - NCT00336934 |
| Two doses of MPX capsules (muscadine grape skin extract) on rising PSA levels in patients following local therapy for pro- state cancer (placebo-controlled trial) |
Ongoing | I/II - NCT01317199 |
| Acai juice in prostate cancer patients with rising PSA after local therapy (single-arm study) |
Ongoing | II - NCT01521949 |
| Kanglaite (Chinese grass seed oil) gelcaps in PSA-recurrent prostate cancer (dose-finding study) |
Ongoing | I/II - NCT01483586 |
| Brassica vegetable diet or indole-3-carbinol pills for patients with PSA recurrence after prostatectomy (2-arm study) |
Ongoing | II - NCT00607932 |
| Combination herbal therapy (vitamins D3 and E, selenium, green tea extract, saw palmetto, lycopene, soy derivatives) for PSA recurrence after local therapy (single-arm study) |
Ongoing | II - NCT00669656 |