French Trial Shows Benefit of Adding Short-Term Hormone Therapy to Salvage Radiotherapy for Rising PSA After Prostatectomy


“In the phase III GETUG-AFU 16 trial reported in The Lancet Oncology, Carrie et al found that adding short-term androgen suppression therapy to salvage radiotherapy was associated with improved biochemical or clinical progression-free survival among patients with prostate cancer who exhibited rising prostate-specific antigen (PSA) levels after radical prostatectomy.

“In the open-label trial, 743 patients from 43 sites were randomized between October 2006 and March 2010 to receive radiotherapy alone (n = 374) or with goserelin (Zoladex; n = 369). Patients had received no previous androgen-deprivation therapy or pelvic radiotherapy and had a rising PSA level of 0.2 to < 2.0 μg/L after having a level < 0.1 μg/L for at least 6 months after surgery with no evidence of clinical disease.

“Treatment consisted of three-dimensional (3D) conformal radiotherapy or intensity-modulated radiotherapy at 66 Gy in 33 fractions 5 days per week for 7 weeks or radiotherapy plus 10.8 mg of goserelin by subcutaneous injection on the first day of radiotherapy and 3 months later. The primary endpoint was progression-free survival in the intention-to-treat population.”

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Androgen Suppression Plus RT Improves DFS in Prostate Ca

“Adding 6 months of androgen suppression (AS) to radiation therapy improved biochemical disease-free survival in high-risk localized prostate cancer patients – even at radiation doses of 78 Gy – and it did so with acceptable adverse effects, according to a randomized European Organisation for Research and Treatment of Cancer trial reported in the Journal of Clinical Oncology.

“At 7.2 years’ median follow-up, the study found that combination therapy led to a 5-year biochemical disease-free survival of 82.6% (95% CI 78.4-86.1) versus 69.8% for radiation alone (95% CI 64.9-74.2) – translating to a hazard ratio of 0.52 (95% CI 0.41-0.66, P=0.001, 319 events). Adjuvant AS also improved clinical progression-free survival, for an HR of 0.63 (95% CI 0.48-0.84, P=0.001, 205 events).

“No statistically significant interaction between treatment effect and radiation dose emerged: heterogeneity P=0.79 and P=0.66, for biochemical disease-free survival and progression-free survival, respectively, according to Michel Bolla, MD, of Grenoble University Hospital in France, and colleagues.”

Longer Androgen Suppression Not Better for Intermediate-Risk Prostate Cancer

The gist: A longer-than-normal androgen suppression treatment before radiation therapy does not improve outcomes for men with intermediate-risk prostate cancer. A recent study compared an 8 week androgen deprivation schedule to a 28 week schedule. Men who were on the 8 week schedule had better outcomes and fewer side effects.

“Extending the duration of androgen suppression from 8 weeks to 28 weeks prior to radiotherapy led to more sexual and endocrine adverse events and did not improve outcomes for men with intermediate-risk prostate cancer. The results of the Radiation Therapy Oncology Group (RTOG) 9910 trial suggest that an 8-week schedule of androgen suppression should remain the standard of care for these patients.

“These results are published in the Journal of Clinical Oncology

” ‘This study has significant and broad implications for best medical practices. Healthcare providers may use [the 8-week] treatment approach with confidence that its outcomes are accurate, reproducible, and generalizable to their patients,’ concluded the study authors.”

Primary Care Involvement Improves Care for Prostate Cancer Patients

A study published in the Journal of General Internal Medicine looked at medical records of men with prostate cancer to see how many men being treated with androgen deprivation therapy (ADT) were evaluated for osteoporosis with a bone mineral density test. ADT is a common cause of osteoporosis, or thinning of the bones, which can often lead to fractures. The findings suggest that men who have a primary care provider involved in their care have a higher rate of testing than men who are cared for by a urologist alone. The study outlines the importance of primary care involvement for patients with prostate cancer.

New Prostate Cancer Drug ODM-201 Shows Promise in Clinical Trial

In a phase I clinical trial, a new drug called ODM-201 was found to be effective and well tolerated by men with prostate cancer. Preclinical studies indicate that the androgen receptor-blocking drug may be more potent than the recently approved drug enzalutamide. The phase I clinical trial has been expanded and a phase II clinical trial is ongoing.

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Denosumab Outshines Zoledronic Acid in Advanced Prostate Cancer

A phase III study evaluated two osteoporosis drugs, denosumab and zoledronic acid, for the treatment of skeletal problems in patients with bone metastases in castration-resistant prostate cancer (CRPC). The average time to first bone-related adverse event was 20.7 months with denosumab and 17.1 months with zoledronic acid, suggesting that denosumab was more effective in this group.

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Two Trials Provide New Answers for Treatment of Advanced Prostate Cancer

New findings from two prostate cancer trials will be presented at the American Society of Clinical Oncology Annual Meeting. One trial determined that men with advanced prostate cancer who receive intermittent hormone therapy survive an average of 5.1 years compared to 5.8 years for men who receive therapy continuously. The second trial determined that abiraterone (Zytiga) in combination with prednisone (a steroid) was effective for the treatment of castration-resistant prostate cancer (CRPC) in patients who have not yet received chemotherapy. Abiraterone is currently approved for patients who have not responded to chemotherapy.

Prostatic Enlargement Drug May Improve Prostate Cancer Screening Results

A recent study evaluated the effects of finasteride (sold as Proscar) on the usefulness of prostate-specific antigen (PSA) screening to detect prostate cancer. Researchers determined that treatment with finasteride may differentiate individuals who have a rise in PSA due to cancer from those who have a rise due to other causes, such as benign enlargement and inflammation. The combination of finasteride with PSA to detect prostate cancer may decrease the rate of unnecessary biopsies.

Patients' Race Linked to Prostate Surgery Quality

Recent data suggests that black men with prostate cancer may have worse outcomes than white men. Several factors appear to be involved, including access to appropriate health care and economic issues.