Tag Archive | "androgen deprivation therapy"

Prostate Cancer Patients on ADT Not Affected by Provenge

A recent study, led by Tomasz Beer, MD, Professor of Medicine at Oregon Health & Science University (OHSU) in Portland, Oregon, found that prostate cancer (PCa) patients on androgen deprivation therapy (ADT) and receiving sipuleucel-T (Provenge) have no adverse outcomes in terms of quality of life.  These findings were presented at the 47th Annual Meeting of the American Society of Clinical Oncology.

The study involved 176 men who were placed on ADT for three to four months after experiencing PSA recurrence after radical prostatectomy.  Sipuleucel-T, which received FDA approval for the treatment of late-stage PCa last year, is not usually used in men with earlier states of prostate cancer.  This is the first study to explore the effect of the autologous cellular immunotherapy on quality of life.

After three to four months, ADT was stopped and all men were randomized to treatment with sipuleucel-T (117 patients) or control (59 patients). Using survey techniques, the researchers assessed quality of life at baseline (following ADT and prior to randomization) and at weeks 13 and 26 after treatment.  Ninety-eight percent of subjects completed baseline quality of life assessment and 92% had at least one post-treatment assessment.  During ADT in the three months before sipuleucel-T treatment, quality of life measures decreased comparably in both study arms.  After the start of the study treatment, there were no significant differences found in the quality of life between the two groups.

Dr. Beer emphasized that the results from the study suggest that a larger study in early disease patients is needed.

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No Significant Association Found Between Androgen Deprivation Therapy and Cardiovascular Death

Treatment with androgen deprivation therapy (ADT) does not significantly increase the risk of cardiovascular mortality according to evaluation of mortality data in a large registry of men treated for prostate cancer.

ADT is commonly used to treat prostate cancer.  Some studies have shown that it may increase the risk of cardiovascular disease, but other studies have not confirmed the association and it remains controversial.  The authors of the recent study tried to explore the evidence further by analyzing the patients registry CAPSURE (Cancer of the Prostate Strategic Urologic Research Endeavor), which includes men with confirmed prostate cancer recruited from 40 mostly community-based US urological practices.

Men who are diagnosed with localized prostate cancer between 1995 and 2007 were included in the analysis, and in order to try to control for factors that may confound the relationship between ADT and cardiovascular death, patients who used and did not use ADT were matched by their propensity to receive ADT.  These patients were categorized into three groups: primary ADT monotherapy, local treatment plus ADT, and watchful waiting/active surveillance (WW/AS).  Initial outcomes were associations between treatment and cardiovascular cause, prostate cancer, and other causes.  Study investigators assessed cause of death using death certificates.

At the point of data capture, there were 13,887 men in the registry, of whom 7,248 were eligible for the analysis.  The majority (71.3%) received local treatment only, 6.7% received local treatment plus ADT, 15% received primary ADT, and 7 percent WW/AS.  It was found that 21.7% received AFT at some point.  Nine hundred seventy six of these men died during the study period, 1.4% from prostate cancer, 2.7% from cardiovascular disease, and 9.4 percent due to other causes.  Patients treated with ADT or WW/AS had a higher likelihood of death due to prostate cancer than those treated just with local therapy.

The largest risk of cardiovascular death was in those treated with WW/AS compared to those only receiving local therapy.  The difference for those treated with local therapy plus ADT was not significant.

The authors’ conclusion is that the increased rate of cardiovascular death in the WW/AS group compared to the ADT group suggests that there are possibly unmeasured variables that affect treatment selection and that confound the association between ADT and cardiovascular death.  The research team notes that when patients were match on propensity to receive ADT, there was no significant association.  The limitation so the study included the relatively small number of deaths in some groups, and the assignment of cause of death from death certificates.

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Sexual Potency After Radiation Therapy for Prostate Cancer Stabilizes After Two Years

According to data from a prospective cohort study by Richard Valicenti, MD, of the University of California Davis and colleagues, sexual function declines in the first two years after external beam radiation therapy (EBRT) for prostate cancer but stabilizes thereafter.  Pretreatment sexual function was the strongest predictor of sexual function at any time after EBRT.  These findings were reported in the International Journal of Radiation Oncology.

These findings debunk the perception that sexual function declines continually after radiation therapy for prostate cancer.

Valicenti said that the results of the study allow patients and their partners to have a fuller understanding of long-term sexual side effects of EBRT and what they can expect after treatment should aid in deciding on a treatment course.

Reported rates of impotency after EBRT for prostate cancer have ranged from eight percent to 85 percent.  The authors attributed this variation to the different instruments used to assess sexual function.

Additionally, many studies included men who received androgen deprivation therapy with EBRT, possibly covering up the contributions of radiation therapy to changes in sexual function.  Many recent studies have suggested that rates of sexual dysfunction increase with follow-up, but few studies included pretreatment assessment of sexual function or conducted serial assessments of sexual function after EBRT.

The investigators prospectively followed 143 men who completed a sexual function questionnaire prior to EBRT for prostate cancer and at each follow-up visit.  The questionnaire assessed four domains of sexual function: sexual drive, erectile function, ejaculatory function, and overall satisfaction.  Scores on all four of these domains and the total score declined significantly in the first two years after EBRT compared to baseline values.  The average age of the patients was 69 year old.

During a median four years of follow-up, the patients completed 1,187 questionnaires.  Some participants were followed for as long as eight years after EBRT.  The baseline scores for sexual drive and erectile function were significantly correlated with age of patient.  Ejaculatory function was significantly correlated with age, race, and marital status.

The patients were grouped according to baseline sexual function.  The scores for the patients above and below the median sexual function value showed that differences in sexual function persisted over time.  Baseline score was the best predictor of later scores for all of the domains assessed.

There were indications that 74.1 percent of the study participants were sexually potent before EBRT.  Of these patients, 74.4 percent remained potent at one year and 70.4 percent at two years after EBRT.  There were no statistically significant changes in potency from year’s two to six.

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Hormone Therapy Used to Treat Prostate Cancer Increases Vertebral Fractures

A recent study found that androgen deprivation therapy (ADT), a hormone therapy that is used to treat prostate cancer, speeds up loss of bone mineral density and increases vertebral fractures, particularly in white men.  The study was published in the Journal of Urology.

The men in the study were enrolled in a fracture prevention trial for prostate cancer patients receiving ADT and were at least 70 years old or had low bone mineral density at the lumbar spine or total hip.

Lead author of the study, Philip J. Saylor, MD, of Boston’s Massachusetts General Hospital, and his colleagues studied 1244 men, including 162 (13%) who had a vertebral fracture at baseline.  Although white race, osteoporosis and low bone density were significantly associated with this finding, age, country of residence and body mass index were not.  According to Saylor, older age, low bone mineral density, and white race prompt patients and doctors to discuss preventative therapy.

The duration of ADT was also not linked to prevalent vertebral fractures, perhaps because the effect on bone mineral density is most apparent in the first year of therapy and the average duration at study entry was four years.

The authors concluded the article by stating that these observations should inform the assessment and management of fracture risk among such men.  Also, in a related editorial, Paul Maroni and E. David Crawford, MDs, of the University of Colorado Health Sciences Center in Denver emphasized the importance of assessing bone health before ADT given the frequency and urgency of the condition.

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Radiotherapy And Androgen Deprivation More Beneficial Than Radiotherapy Alone in Some Prostate Cancer Patients

In a recent study funded by grants from the National Cancer Institute and published in the New England Journal of Medicine, it was reported that short-term androgen-deprivation therapy improves survival in men with intermediate-risk, localized prostate cancer.  From 1994 to 2001, one thousand seventy nine men with localized prostate cancer and prostate-specific antigen levels of 20 ng/mL or less were randomized to receive radiotherapy alone (992 patients) or radiotherapy plus four months of androgen-deprivation therapy (987 patients).

The overall ten-year survival rate was significantly higher with combination therapy than with radiation alone, and combination therapy decreased disease-specific deaths.  The median follow-up period was 9.1 years, and the ten-year rate of overall survival was 62% among patients receiving radiotherapy plus short-term ADT (the combined-therapy group), as compared with 57% among patients receiving only radiotherapy.  The addition of short-term ADT was associated with a decrease in the 10-year disease-specific mortality from eight percent to four percent. Biochemical failure, distant metastases, and the rate of positive findings on repeat prostate biopsy at two years were significantly improved with radiotherapy plus short-term ADT.  In the two groups, acute and late radiation-induced toxic effects were similar.

The study was carried out because it had not been known whether short-term androgen-deprivation therapy (ADT) before and during radiotherapy improves cancer control and overall survival among patients with early, localized prostate adenocarcinoma.

It was found in a post-hoc analysis that the benefits of combination therapy were limited to men with intermediate-risk disease rather than men with low-risk cancer.

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Prostate Cancer Survival Rate Improves with Short Term Hormone Therapy Coupled with Radiation Therapy

A new study published by the Radiation Therapy Oncology Group (RTOG) in the New England Journal of Medicine and supported by grants from the National Cancer Institute found that short-term hormone therapy (androgen deprivation therapy –ADT) given in combination with radiation therapy for me in early-state prostate cancer increases their chance of surviving longer and not dying from the cancer.  This was the largest randomized trial of its kind, enrolling almost 2,000 men at low and intermediate risk of prostate cancer progression and following their health status from October 1994 to April 2001 at 212 centers throughout the United States and Canada.

Male hormones (androgens) including testosterone increase the growth of prostate cancer cells.  Therapy that decreases the body’s levels of androgens (particularly four months of ADT starting two months prior to radiation therapy in this study) removes the strongest growth factor for prostate cancer cells.  Authors of the study report that adding short-term ADT to radiation therapy significantly improved the overall survival rate at 10 years from 57 to 62 percent.  Additionally, in a trial of different treatments on each of the patients’ two arms, the radiation therapy coupled with short-term ADT arm was associated with four percent fewer prostate cancer-related mortalities compared with the radiation therapy-alone arm.  More importantly, the reduction in disease-specific deaths was accounted for by the intermediate-risk study participants in the radiation therapy plus ADT arm (10 percent as opposed to three percent in radiation only arm at 10 years) while no reduction in deaths was seen among low-risk participants at 10 years.  These benefits were achieved with a mild increase in patient-reported erectile dysfunction at one year but no increase in observed long-term bowel or bladder toxicities.

About 240, 890 Americans will be diagnosed with prostate cancer in 2011 and almost 9 out of 10 will have early-stage disease.

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Investigational Drug Cabozantinib Active Against Advanced Prostate Cancer

When prostate cancer stops responding to androgen deprivation therapy (ADT), it is referred to as hormone-refractory prostate cancer. Although advances have been made in the treatment of hormone-refractory prostate cancer, challenges remain and new drugs continue to be developed.

An investigational drug called Cabozantinib is showing promise in the treatment of hormone-refractory prostate cancer particularly among patients with bone metastases.

Researchers conducted a Phase II clinical trial among 171 patients with progressive cancer in which more than three-quarters of the men had bone metastases. All patients were initially treated with 12 weeks of Cabozantinib. On bone scan, 76% of the patients with bone metastases had partial or complete disappearance of the bone metastases. For patients taking narcotics for bone pain, 67% had a reduction in pain and 56% decreased or stopped their narcotic use. More than two thirds of patients had some reduction in metastases outside of the bone.

Side effects include fatigue, gastrointestinal symptoms and high blood pressure.

These results were presented at the 2011 annual meeting of the American Society of Clinical Oncology.

Additional studies are underway.

Cabozantinib has not yet been approved by the U.S. Food and Drug Administration.

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