The “Quality of Life and Satisfaction with Outcomes” study

As far as we are aware, there has only ever been one large, prospective, multi-center, clinical study that set out to measure the impact of the side effects of treatment on patients’ and their partners’ satisfaction with the outcomes of first-line treatment for prostate cancer. We have provided a summary of the results of this study below, but the interested reader can also obtain a copy of the full paper on line.

The Study Design

Sanda and his colleagues enrolled 1,201 newly diagnosed prostate cancer patients and their spouses or partners into this study between March 2003 and March 2006. All patients had been diagnosed with untreated T1 or T2 prostate cancer, were treated at one of nine university-affiliated medical centers, and had chosen to be treated with one of the three most commonly used forms of first-line prostate cancer therapy:

  • Radical prostatectomy (using open retropubic, laparoscopic, or robot-assisted laparoscopic techniques)
  • Brachytherapy (alone, in combination with external beam radiotherapy, in combination with hormone therapy, or in combination with external beam radiation and hormonal therapy)
  • External beam radiation therapy (using intensity-modulated  or conformal techniques with or without hormone therapy)

The precise numbers of patients receiving each type of therapy are given in detail in the paper.

The median age of the patients was 63 years, but ranged from as young as 38 to as old as 84 years of age. The median age of their partners and spouses  was 59, with a range from 23 to 89 years of age. Nine percent of the patients and 7 percent of their partners were black. There were no prostate cancer-related deaths, and only 14/1,201 patients (1.2 percent) had a biochemical recurrence of their disease after first-line treatment. Three patients (0.3 percent) had serious adverse events immediately following treatment.

Clearly, this was a complex study, in which individual patient outcomes were affected by things like the patient’s age, the severity of his cancer, any coexisting illnesses, etc. We are not going to try to get into all of these details. Our intention in this summary of the study is to try to draw out the critical information for a newly diagnosed patient who needs to understand how his reaction to a specific form of treatment after he has been treated may impact how he (and his partner) feel about their earlier decision and their post-treatment quality of life.

It is very important for you to understand that (in the words of the authors), “our analyses are appropriate for expectations with respect to outcome within study groups and not for a comparison among treatments.” (In other words, you can’t really make detailed comparisons between, for example, the outcomes of the patients in the surgery group and the patients in the radical prostatectomy group.) Having said that, however, there are certain results that clearly speak for themselves.

Quality of Life Scores

Post-Treatment Sexual Quality of Life — Sexual quality of life scores were affected by all forms of therapy, with an average sexual quality of life score of 45 to 55 out of a possible 100 at 2 years after treatment for those who received nerve-sparing surgery, external beam radiotherapy alone, or any form of brachytherapy. For patients who received non-nerve-sparing surgery or external beam radiotherapy in combination with hormone therapy, average post-treatment sexual quality of life scores at 2 years were more like 20 to 25 out of 100. Furthermore, all patients who received surgical treatment had a mean sexual quality of life of about 20 out of 100 immediately following treatment. The patients who had the nerve-sparing procedure tended to recover some of their former their sexual quality of life over the next 2 years.

Post-treatment Urinary Incontinence Scores — Urinary incontinence had the highest level of impact on men who received surgery, with average scores dropping to about 30/100 at 2 months post-surgery, regardless of surgical type, and then gradually recovering to 80/100 for patients who had nerve-sparing surgery or 70/100 for the patients who had non-nerve-sparing operations. For patients treated with external beam radiotherapy, the average urinary incontinence score was relative stable at about 85/100 over time. For the brachytherapy patients it varied from 95/100 to 80/100 over the first year and then tended to stabilize at around 85/100.

Post-treatment Urinary Irritation/Obstruction Scores — For patients treated with surgery, these scores tended to increase slightly over time, from around 85/100 pretreatment to more like 90/100 post-treatment. For patients treated with external beam radiotherapy, these scores tended to drop significantly immediately after treatment (to between 70/100 and 80/100) but then recovered again to around 85/100 at 2 years. However, for the brachytherapy patients there was a slightly larger drop immediately post-treatment, with a gradual recovery over 2 years to more like 75/100 or 80/100.

Post-treatment Bowel or Rectal Scores — Mean bowel and rectal scores for surgical patients appeared to be utterly unaffected by treatment at around 95/100. In the case of the external beam radiotherapy patients, there was an early drop in the average bowel/rectal score (to as low as 75/100) followed by a gradual rise back to around 90/100 at 2 years. The same was true for the brachtherapy patients, except that the initial drop was no lower than 80/100.

Post-treatment Vitality or Hormonal Scores — For the men who received nerve-sparing surgery, average post-treatment vitality scores remained stable at about 95/100, but for those who had non-nerve-sparing surgical procedures, vitality dropped to more like 85/100 and then stabilized at that level. For the patients who received external beam radiation, there was a temporary “dip” in the average vitality score, which was reversed at 6 months, with the score stabilizing at about 90/100; however, for the radiotherapy patients who also received hormones, mean vitality initially dropped below 80/100 and gradually went back up to about 85/100 at 2 years. For the brachytherapy patients, similar patterns were observed to those seen in the radiotherapy patients, except that at 2 years mean vitality scores were >90/100, regardless of whether the patient had received hormone therapy or not.

Key Factors Affecting Quality of Life Scores

For each quality of life domain, certain underlying patient characteristics clearly had an independent impact on post-treatment quality of life. The characteristics listed below all had independent impact on post-treatment quality of life with a P value  ≤ 0.01:

  • In the sexuality domain: satisfaction was affected by age, PSA score, and nerve-sparing for the surgical patients; by age, prostate size, and neoadjuvant hormone therapy for the external beam radiation patients; and by age and PSA score only for the brachytherapy patients.
  • In the urinary incontinence domain: satisfaction was impacted by age alone for the surgical patients and by neoadjuvant hormone therapy and combination with external beam radiation boost for the brachytherapy patients.
  • In the urinary irritation/obstruction domain: satisfaction was affected by prostate size in the surgery patients; by prostate size and by neoadjuvant hormone therapy in the external beam radiation patients; and by neoadjuvant hormone therapy among the brachytherapy patients.
  • Bowel and rectal function did not appear to be affected by any specific patient characteristic with this level of significance.
  • In the vitality or hormonal function domain: satisfaction was affected by obesity, prostate size, and neoadjuvant hormone therapy in the external beam radiation therapy patients, and by prostate size, neoadjuvant hormone therapy, and combination with an external beam radiotherapy boost among the brachytherapy patients.

Summary of Critical Results

The authors call out the following results as being the key learnings from this study:

  • Adjuvant hormone therapy is associated with worse outcomes across multiple quality of life domains when used in combination with external beam radiation and brachytherapy.
  • Brachytherapy patients reported long-lasting urinary, bowel, and sexual symptoms, as well as transient problems with vitality or hormonal function.
  • The adverse effects of radical prostatectomy were fewer among patients who had the nerve-sparing type of procedure.
  • Urinary incontinence was common following prostatectomy, but symptoms of urinary irritation and obstruction improved (particularly in patients with large prostates).
  • Treatment-related symptoms were generally exacerbated by obesity, by a large prostate size, by a high pretreatment PSA level, and by greater age.
  • Black patients were generally less satisfied with their outcomes than Caucasian patients.
  • Changes in quality of life were associated with degree of outcome satisfaction among patients and their partners or spouses.

In Conclusion

The data provided in this study do not in any way offer the newly diagnosed patient the sort of perfect information that he can used to decide exactly which form of treatment is liable to give him, as an individual, the very best outcome after treatment. We do not believe it is possible to construct a study that would be able to provide a perfect answer to that question (at least given current treatment options for localized prostate cancer).

All that the data from this study can do is offer you some general guidance about what is reasonably expectable on average. The data are what they are. We wish better guidance could be offered, but it just isn’t available.

The major take-away from this study is that all forms of the most common types of treatment have some downsides. The degree to which these may affect the individual patient is the great unknown.