Table 1.
Contemporary Trials of High Dose Androgen Therapy.
| Patient Population | No. of Patients | Treatment Regimen | Serum T Level | PSA Response | Objective Response | Median Time to Progression | Caner Related Adverse Effects | Ref. |
|---|---|---|---|---|---|---|---|---|
| CRPC (disease burden or symptoms not designated) | 12 | T via 5 mg transdermal patch or 1% gel for 1 week, 1 month, or until disease progression | physiologic (342–876 ng/dL) | 1 patient had PSA decline >50% from baseline | none | 84 days (23–247 days) | [65] | |
| CRPC with minimal metastatic disease | 15 | transdermal T at 25, 5.0 or 75 mg/day | physiologic (94–824 ng/dL) | 3/15 (20%) had PSA declines from baseline (largest decline 43%) | none | 63 days (14–672 days) | one patient with symptomatic progression | [66] |
| Asymptomatic CRPC with low to moderate metastatic burden | 16 | T (400 mg IM day 1 of 28) and etoposide (100 mg oral daily; days 1 to 14 of 28) | T > 1500 ng/dL (~50 nM) at 2 days after T injection (range 920 to >3200 ng/dL), above 600 ng/dL at 2 weeks, and 150 ng/dL by 28 days | 7/14 (50%) had PSA declines from baseline (≥50%) | radiographic responses in 5/10 (50%), and 4 continued on treatment for ≥1 year | 11 months (3 to not reached) | 2 patients were not evaluable because they came off study after only one cycle of therapy due to toxicity | [9] |
| CRPC post progression on enzalutamide | 30 | alternating 3 month cycles of BAT (T 400 mg IM on days 1, 29 or 57), followed by 3 months of ADT alone | not reported | 9/30 (30%) men achieved a ≥50% decline in PSA from baseline | 50% of patients achieving an objective radiographic response | 8.6 months (4.7 to not reached) | 3 patients progressed per RECIST criteria and 3 had unconfirmed progression on bone scan | [11] |
| Asymptomatic hormone naïve with low metastatic burden or biochemically recurrent disease, who achieved PSA <4 ng/dL after 6 months of ADT | 29 | T 400 mg IM on days 1, 29, and 57 | not reported | 17/29 (59%) achieved primary endpoint of PSA < 4 ng/dL after 18 months | 4 of 10 evaluable patients had complete and 4 had partial responses (80%) | not given | 3 patients taken off study prior to completing 2 cycles due to concerns for early progression | [10] |
CRPC: castration resistant prostate cancer; T: testosterone; PSA: prostate specific antigen; BAT: bipolar androgen therapy; IM: intra-muscular; ADT: androgen deprivation therapy.