Prostate Cancer Treatment (PDQ®): Treatment - Health Professional Information [NCI] - Recurrent Prostate Cancer Treatment
Evidence (palliation for bone metastases using denosumab):
- A placebo-controlled, randomized trial (NCT00321620) compared denosumab with zoledronic acid for the prevention of skeletal events (pathologic fractures, spinal cord compression, or the need for palliative bone radiation or surgery) in men with hormonal therapy-resistant prostate cancer with at least one bone metastasis.
- The trial reported that denosumab was more effective than zoledronic acid; median time to first on-study skeletal event was 20.7 versus 17.1 months (HR, 0.82; 95% CI, 0.71–0.95).
- Serious adverse events were reported in 63% of denosumab patients versus 60% in patients on zoledronic acid. The cumulative incidence of osteonecrosis of the jaw was low in both study arms (2% in the denosumab arm vs. 1% in the zoledronic acid arm). There was grade 3 to 4 toxicity. There was no difference in survival. The incidence of hypocalcemia was higher in the denosumab arm (13% vs. 6%).
Treatment Options for Recurrent Prostate Cancer
Treatment options for recurrent prostate cancer include the following:
- Chemotherapy for hormonal management of prostate cancer.
Chemotherapy for hormonal management of prostate cancer
Evidence (chemotherapy for hormonal management of prostate cancer):
- A randomized trial showed improved pain control in patients with hormone-resistant prostate cancer treated with mitoxantrone plus prednisone compared with those treated with prednisone alone. Differences in OS or measured global quality of life between the two treatments were not statistically significant.
- In a randomized trial involving patients with hormone-refractory prostate cancer, docetaxel (75 mg/m2 every 3 weeks) and docetaxel (30 mg weekly for 5 out of every 6 weeks) were compared with mitoxantrone (12 mg/m2 every 3 weeks). All patients received oral prednisone (5 mg twice per day). Patients in the docetaxel arms also received high-dose dexamethasone pretreatment for each docetaxel administration (8 mg given at 12 hours, 3 hours, and 1 hour prior to the 3-week regimen; 8 mg given at 1 hour prior to the 5 out-of-every-6 weeks' regimen).
- OS at 3 years was statistically significantly better in the 3-weekly docetaxel arm (18.6%) than in the mitoxantrone arm (13.5%, HRdeath of 0.79; 95% CI, 0.67–0.93).
- However, the OS rate for the 5 out-of-every-6 weeks' docetaxel regimen was 16.8%, which was not statistically significantly better than mitoxantrone.
- Quality of life was also superior in the docetaxel arms compared with mitoxantrone (P = .009).[Levels of evidence: 1iiA, 1iiC]
- In another randomized trial involving patients with hormone-refractory prostate cancer, a 3-week regimen of estramustine (280 mg orally 3 times a day for days 1 to 5, plus daily warfarin and 325 mg aspirin to prevent vascular thrombosis), and docetaxel (60 mg/m2 intravenously [IV] on day 2, preceded by dexamethasone [20 mg times 3 starting the night before]) was compared with mitoxantrone (12 mg/m2 IV every 3 weeks) plus prednisone (5 mg daily).[Level of evidence: 1iiA]
- After a median follow-up of 32 months, median OS was 17.5 months in the estramustine/docetaxel arm versus 15.6 months in the mitoxantrone arm (P = .02; HRdeath of 0.80; 95% CI, 0.67–0.97).
- Global quality of life and pain palliation measures were similar in the two treatment arms.[Level of evidence: 1iiC]
In patients with hormone-resistant prostate cancer whose disease progressed during or after treatment with docetaxel, cabazitaxel was shown to improve survival compared with mitoxantrone in a randomized trial (NCT00417079). In this trial, 755 such men were treated with daily oral prednisone (10 mg) and randomly assigned to receive either cabazitaxel (25 mg/m2 IV) or mitoxantrone (12 mg/m2 IV) every 3 weeks.[Level of evidence; 1iiA]
- Median OS was 15.1 months in the cabazitaxel arm and 12.7 months in the mitoxantrone study arm (HRdeath of 0.70; 95% CI, 0.59–0.83; P < .0001).