FYI: Radiation With Antiandrogen Therapy Improves Survival in Recurrent Prostate Cancer, The New England Journal of Medicine

Published in Oncology

Journal Scan / Research · February 10, 2017

* This study sought to determine whether adding antiandrogen therapy to radiation therapy would improve cancer control and prolong survival among men who have undergone radical prostatectomy and who have experienced symptoms of a recurrence. The authors performed a double-blind, placebo-controlled trial that enrolled 760 eligible patients for whom adding 24 months of antiandrogen therapy with daily bicalutamide to salvage radiation therapy resulted in a significant improvement in overall survival at 12 years (76.3% vs 71.% for placebo; P = .04).


* Adding 24 months of antiandrogen therapy with daily bicalutamide to salvage radiation therapy produced significant improvements in long-term overall and prostate cancer–specific survival compared with r

BACKGROUND

Salvage radiation therapy is often necessary in men who have undergone radical prostatectomy and have evidence of prostate-cancer recurrence signaled by a persistently or recurrently elevated prostate-specific antigen (PSA) level. Whether antiandrogen therapy with radiation therapy will further improve cancer control and prolong overall survival is unknown.

METHODS

In a double-blind, placebo-controlled trial conducted from 1998 through 2003, we assigned 760 eligible patients who had undergone prostatectomy with a lymphadenectomy and had disease, as assessed on pathological testing, with a tumor stage of T2 (confined to the prostate but with a positive surgical margin) or T3 (with histologic extension beyond the prostatic capsule), no nodal involvement, and a detectable PSA level of 0.2 to 4.0 ng per milliliter to undergo radiation therapy and receive either antiandrogen therapy (24 months of bicalutamide at a dose of 150 mg daily) or daily placebo tablets during and after radiation therapy. The primary end point was the rate of overall survival.

RESULTS

The median follow-up among the surviving patients was 13 years. The actuarial rate of overall survival at 12 years was 76.3% in the bicalutamide group, as compared with 71.3% in the placebo group (hazard ratio for death, 0.77; 95% confidence interval, 0.59 to 0.99; P=0.04). The 12-year incidence of death from prostate cancer, as assessed by means of central review, was 5.8% in the bicalutamide group, as compared with 13.4% in the placebo group (P<0.001). The cumulative incidence of metastatic prostate cancer at 12 years was 14.5% in the bicalutamide group, as compared with 23.0% in the placebo group (P=0.005). The incidence of late adverse events associated with radiation therapy was similar in the two groups. Gynecomastia was recorded in 69.7% of the patients in the bicalutamide group, as compared with 10.9% of those in the placebo group (P<0.001).

CONCLUSIONS

The addition of 24 months of antiandrogen therapy with daily bicalutamide to salvage radiation therapy resulted in significantly higher rates of long-term overall survival and lower incidences of metastatic prostate cancer and death from prostate cancer than radiation therapy plus placebo.

Hopefully this study helps some of you facing recurrence. I know from personal experience that initiating ADT is a difficult decision to make following recurrence after a prostatectomy. This study, a repetition of smaller studies, provides more support for radiation treatment following your providers recommendations.

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  • Thank you for this report. Was there any mention regarding the resolution of the gynecomastia that almost 70% experienced? Just curious if it was permanent or not.

  • One big question in my mind is whether two years is really necessary, or whether six months, or even three months, will do just as well.

    When I had radiation treatment in 2003 I did a lot of searching for studies on ADT given before, during, and after radiation. If I remember correctly, I found at least one study that used six months of ADT and the result were only slightly worse than the ones using 2-3 years. I'm imagining that the biggest benefit from ADT is to weaken the tumor cells before hitting them with radiation, to keep them weak during the radiation, and to keep them weak for at least a short while afterwards while some of the ones that were damaged but not killed by the radiation are still struggling. I speculate that not many of the tumor cells in the radiation target field that are still alive after some period of months are going to be killed by more ADT.

    I wish they had three groups in the study:

    1) no ADT

    2) 6 months of ADT

    3) 24 months of ADT

    I had a total of 4 months of ADT treatments although it was over 5 months before my testosterone began to climb back to normal. I had no gynecomastia that I noticed.

  • No there was not. If this is a problem for you consider discussing Casodex with your provider. Casodex leaves a residual of Testosterone while suppressing Androgen. It has become a stand alone ADT drug substituted for Lupron or switched Intermittently to prolong castration resistance.