|Drug||Clinical trial ID||Phase||Status||Protocol||Outcome||Ref.|
|Vorinostat/SAHA||NCT00330161||II||Completed||Metastatic PCa with disease progression on prior chemotherapy received 400 mg vorinostat/SAHA orally each day. Disease progression measured at 6 months. n = 27||Toxicity: significant toxicities including fatigue, nausea. IL-6 (Interleukin 6) was higher in patients with toxicity. 7 % patients achieved a stable disease state. No PSA decline >50 % observed. Median time to progression and overall survival were 2.8 and 11.7 months, respectively. Significant toxicities reported.|||
|Vorinostat/SAHA||NCT00005634||I||Completed||Patients with advanced or metastatic solid tumors that have not responded to previous therapy received vorinostat/SAHA I.v. on days 1–3 every 21 days. n = 45||Determine the tolerability, pharmacokinetic profile, and biologic effects of the drug. Not available|
|Vorinostat/SAHA and docetaxel||NCT00565227||I||Terminated due to toxicity||Patients with advanced and relapsed tumors received oral vorinostat/SAHA for the first 14 days of a 21-day cycle, with docetaxel I.v. on day 4 of each cycle. n = 12||Toxicity: neutropenia, peripheral neuropathy, and gastrointestinal bleeding. The combination of vorinostat/SAHA and docetaxel was poorly tolerated. No responses were identified.|||
|Vorinostat/SAHA and doxorubicin||NCT00331955||I||Completed||Patients receive oral vorinostat/SAHA twice daily for 5 doses on days 1–3, 8–10 and 15–17 and doxorubicin I.v. on days 3, 10, and 17 very 28 days for up to 6 courses. n = 32||Partial response was achieved in one of the two PCa patients enrolled.|||
|Vorinostat/SAHA and androgen deprivation therapy (ADT)||NCT00589472||II||Completed||Localized PCa patients received neo-adjuvant vorinostat/SAHA with oral bicalutamide with either I.M. leuprolide or subcutaneous goserelin acetate administered for up to 8 weeks or until the day of surgery. n = 19||Determine the rate of pathologic complete response in patients with localized PCa treated with ADT and vorinostat/SAHA before radical prostatectomy measuring androgens in blood. Not available|
|Vorinostat/SAHA and mTOR inhibitor temsirolimus||NCT01174199||I||Ongoing, not recruiting||Metastatic PCa patients received oral vorinostat once daily on days 1–14 and temsirolimus intravenously on days 1, 8, and 15 of a 21-day cycle. n = 13||Determine the safety, tolerability, partial and complete objective response rates, progression-free survival and overall survival, and PSA response. Not available|
|Panobinostat||NCT00667862||II||Completed||I.v. panobinostat (20 mg/m2) was administered to CRPC patients on days 1 and 8 of a 21-day cycle. Disease progression measured at 24 weeks. n = 35||
Toxicity: fatigue, thrombocytopenia, nausea|
14 % patients demonstrated a decrease in PSA but none >50 %. No clinical activity.
|Panobinostat (LBH589), docetaxel, and prednisone||NCT00663832||I||Completed||CRPC patients received oral panobinostat (20 mg/m2) on days 15 for 2 consecutive weeks. On the other arm, patients received oral panobinostat (15 mg/m2) with docetaxel I.v. (75 mg/m2) every 21 days and oral prednisone (5 mg) twice every day of a 21-day cycle. n = 16||
Toxicity: dyspnea and neutropenia|
Panobinostat in combination with docetaxel and prednisone in patients with CRPC resulted in 63 % of patients with >50 % decline in PSA levels. No relevant anti-tumor activity.
|Panobinostatbicalutamide||NCT00878436||I/II||Completed||Men with CRPC received treatment with bicalutamide (50 mg PO) daily with oral panobinostat at 2 dose levels (20 or 40 mg). Minimum treatment was 3 weeks. n = 9||
In 2 patients, it was registered a >50 % PSA decline by 9 months of therapy; and 3 patients presented stable PSA levels.
|Panobinostat docetaxel and prednisone||NCT00493766||I||Terminated because of a strategic decision||In one arm, oral panobinostat alone is given to patients with progressing hormone refractory prostate cancer. In the other arm, oral panobinostat along with I.v. docetaxel and oral prednisone is administered. n = 16||Toxicity: dyspnea, neutropenia, fatigue. Exposure to oral panobinostat was similar with and without docetaxel.|
|Panobinostat, docetaxel, and prednisone||NCT00419536||I||Terminated because of a strategic decision||Not available||Determine maximum tolerated dose of panobinostat and to characterize the safety, biological activity, and pharmacokinetic profile.|
n = 7
|Establish toxicity, tolerability, and safety of oral panobinostat when given in combination with radiotherapy. Not available|
|Romidepsin||NCT00106418||II||Completed||mCRPC patients received romidepsin (13 mg/m2) intravenously on days 1, 8, and 15 every 21-day cycle. Disease progression measures at 6 months. n = 35||
Toxicity: nausea, fatigue|
2 patients reached a confirmed radiological partial response of over 6 months, in addition to >50 % PSA decline. 11 patients had to discontinue the therapy due to toxicity. Romidepsin demonstrated minimal anti-tumor activity in chemonaive patients with CRPC.
|Romidepsin||NCT00106301||II||Completed||Patients with CRPC were continued at the same dose of romidepsin as in the previous study, which could have been 13 mg/m2 or a reduced dose of 10 mg/m2, on days 1, 8, and 15 of each 28-day cycle. n = 2||Evaluate adverse effects and effect of romidepsin and evaluate the time of disease progression. Not available|
|Romidepsin in solid tumors with liver dysfunction||NCT01638533||I||Currently recruiting patients||Patients with recurrent prostate carcinoma receive romidepsin I.v. on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. n = 132||Establish the safety and tolerability, pharmacokinetics, and maximum tolerated dose. Not available|
|Pracinostat||NCT01075308||II||Completed||Recurrent or mCRPC patients received pracinostat orally (60 mg) 3 times a week for 3 consecutive weeks followed by 1 week off-dosing of a 28-day cycle. n = 32||
Toxicity: fatigue, neutropenia|
2 patients achieved a decline >50 % of PSA. In patients with measurable disease, there were no objective responses, while 7 patients had stable disease lasting 1.7 to 8 months.
|Valproic acid||NCT00670046||II||Not provided||Non-metastatic with biochemical progression PCa patients received oral valproic acid twice daily for up to 1 year in the absence of disease progression or unacceptable toxicity. n = 50||Percentage of patients exhibiting observed or predicted PSA doubling time >10 months after initiation of the study. Not available|
|Valproic acid and bevacizumab||NCT00530907||I||Completed||Bevacizumab was administered at escalating dosages of 2.5–11 mg/kg on days 1 and 15, and oral valproic acid at dosages of 5.3–10 mg/kg on days 1–28, every 28. n = 57||Toxicities: grade 3 altered mental status (n = 2), related to valproic acid. Bevacizumab 11 mg/kg given on days 1 and 15 and valproic acid 5.3 mg/kg daily were the recommended phase II dosages. Stable disease ≥6 months were reported in 4/57 of patients. Of the 39 patients evaluated for histone acetylation, 2 of 3 (67 %) patients with stable disease ≥6 months showed histone acetylation, while 8 of 36 (22 %) without stable disease ≥6 months demonstrated histone acetylation (p = 0.16). Patients with hypertension had improved overall survival.|||
|Sulforaphane||NCT01228084||II||Completed||Patients with biochemical (PSA) recurrent PCa received 200 μmoles/day sulforaphane-rich extracts during 20 weeks. n = 20||1 patient experienced a ≥50 % PSA decline and 7 patients had PSA declines >50 %. No grade 3 events reported.|||
|Sulforaphane||–||II||Completed||PCa patients with increasing PSA levels after prostatectomy orally received 60 mg of sulforaphane or placebo for 6 months. n = 78||Sulforaphane-treated patients presented 86 % longer PSA-DT than the placebo group. Increases >20 % of PSA levels higher in the placebo group (71.8 %) compared to the sulforaphane-treated group (44.4 %)|||
|MGCD-0103 and docetaxel||NCT00511576||I||Terminated||Patients received escalating doses of oral MGCD-0103 in combination with two fixed doses of I.v. docetaxel (60 mg/m2 and 75 mg/m2). n = 54||Determine the maximum tolerated dose, dose limiting toxicitie,s and safety profile of escalating doses of oral MGCD-0103 in combination with two fixed doses of docetaxel. Not available|
|Curcumin||NCT02064673||II||Recruiting||PCa patients with localized disease who were submitted to a radical prostatectomy received oral curcumin or placebo 500 mg twice a day for 6 months. n = 600||Determine recurrence-free survival as total PSA <0.2 ng/ml. Not available|
|Curcumin, prednisone, and docetaxel||–||II||Patients with progressing CRPC and a rising PSA received docetaxel/prednisone for 6 cycles in combination with curcumin, 6000 mg/day (day −4 to day +2 of docetaxel). n = 30||Decreased PSA levels were observed in 59 % of patients and 40 % of evaluable patients presented a partial response. The regimen was well tolerated.|||
|Curcumin and radiotherapy||NCT01917890||Not provided (pilot)||Completed||PCa patients undergo 74 Gy radiotherapy 5 times a week for 7–8 weeks and take 3 g of curcumin vs placebo. n = 40||The change in urinary symptoms across the 20-week period differed significantly between groups (p = 0.011) and patients in the curcumin group experienced much milder urinary symptoms compared with the placebo group. Curcumin could not reduce the severity of bowel symptoms or other treatment-related symptoms. PSA levels were reduced to below 0.2 ng/ml in both groups.|||
|Curcumin and taxotere||NCT02095717||II||Recruiting||mCRCP patients receive taxotere plus curcumin capsule vs taxotere plus placebo. n = 100||Assess time to progression of metastatic disease by tumor response rate, increase in PSA levels (≥25 % and ≥2 ng/ml increase) or the appearance of new lesions metastatic. Not available|
|Phenelzine||NCT02217709||II||Recruiting||Recurrent non-metastatic PCa received phenelzine daily and orally during 12 months. n = 46||Determine biochemical recurrent prostate cancer by PSA decline to ≥50 % following at least 12 weeks of treatment. Not available|
|Phenelzine and docetaxel||NCT01253642||II||Recruiting||PCa patients with progressive disease after first-line therapy with docetaxel received phenelzine orally once a day on days −7 to −4 and twice a day on days −3 to 21 and docetaxel I.v. on day 1. Treatment repeats every 21 days for at least 12 weeks. nn = 30||Determine the proportion of patients who experience a PSA decline of at least 30 % and duration of progression-free survival. Not available|
|OTX015||NCT02259114||IB||Recruiting||Advanced solid tumors including CRPC. Patients divided in two regimens: (1) continuous, once daily for 21 consecutive days and (2) once daily on days 1 to 7, repeated every 3 weeks (1 week on/2 weeks off). n = 98||Determine maximum tolerated dose and the number of dose limiting toxicity. Not available|