Whole-gland cryoablation as first-line therapy in prostate cancer patients > 75 years of age

Based on data collected in the Cryo On-Line Database (COLD), Dhar et al. have just published an analysis of data from a total of 860 men, all over 75 years of age, who were treated with whole-gland cryoablation for clinically localized prostate cancer at times dating back to at least 1995.

We should be very clear up front (as are the authors and an editorial commentator) that there is great controversy over the appropriate management of clinically localized prostate cancer, particularly in older patients, and the authors do not seek to make any comment on whether these patients should have undergone treatment or not. They are simply reporting the results of treatment after a treatment decision had been made.

The paper by Dhar et al. is based on data from 3,209 patients in the COLD registry who underwent whole-gland cryoablation as their primary form of treatment. Because men over 75 years of age are (at least theoretically) at greater risk for morbidity (complications) as a consequence of treatment compared to younger men, the authors were particularly interested in examining that risk. They were careful to categorize the patients who were eligible for analysis based on the D’Amico risk criteria.

Here is a summary of the key findings:

  • The COLD registry contained data on 860 patients who met eligibility criteria for analysis.
    • 127/860 patients (15 percent) met D’Amico criteria for low-risk disease.
    • 446/860 patients (52 percent) met D’Amico criteria for intermediate-risk disease.
    • 279/860 patients (32 percent) met D’Amico criteria for high-risk disease.
    • 8/860 patients (1 percent) could not be classified according to the D’Amico criteria because data was missing.
  • These patients had been treated at 25 different institutions.
  • The median patient age was 79 years (range, 76 to 91 years).
  • The median follow-up was 16 months (range, 4 to 60 months).
  • The actuarial, 5-year biochemical disease-free survival (bDFS) of the patients, based on the ASTRO definition of freedom from biochemical progression was
    • 79.0 ± 4.0 percent for the complete cohort
    • 82.4 ± 7.9 percent for the low-risk patients
    • 78.3 ± 5.8 percent for the intermediate-risk patients
    • 77.6 ± 7.7 percent for the high-risk patients
  • The actuarial, 5-year bDFS, based on the Phoenix definition of freedom from biochemical progression was
    • 62.6 ± 8.3 percent for the complete cohort
    • 74.9 ± 15.3 percent for the low-risk patients
    • 61.4 ± 13.2 percent for the intermediate-risk patients
    • 58.0 ± 11.9 percent for the high-risk patients
  • 1/860 patients (0.1 percent) had a rectal-urethral fistula
    • This patient was treated prior to 1995  using liquid nitrogen rather than liquid argon as the coolant, and the urethral warmer malfunctioned during the procedure.
    • The patient was successfully treated for his fistula and is still alive 16 years post-treatment.
  • Temporary urinary retention after treatment was reported in 51/860 men (5.9 percent).
    • The urinary retention resolved in 43/51 patients (84.3 percent).
    • 8/51 patients (15.7 percent) required transurethral resection of the prostate (TURP) to remove sloughed tissue.
  • Post-treatment on continence was available on 460/860 patients (53.5 percent).
    • At 12 months post-treatment, incontinence was reported in 8/460 patients (1.7 percent).
    • Data on post-treatment continence was not based on validate questionnaires and may therefore be under-reported.
  • Post-treatment data was available on 129/860 patients (15.0 percent) who claimed to be sexually potent prior to treatment.
    • Only 14/129 of these patients (10.8 percent) claimed to be sexually potent after treatment.
    • Data on post-treatment potency was not based on validated questionnaires.

Although the treatment of localized disease in men > 75 years of age is most certainly controversial, there are useful take-aways from this analysis of data in the COLD registry, as follows:

  • Whole-gland cryotherapy appears to have a relatively high level of efficacy at 5 years of follow-up in this cohort of 860 patients, 84 percent of whom had intermediate- and high-risk prostate cancer.
  • Whole-gland cryotherapy is associated with a high risk for post-surgical impotence (but this many not be important to a significant percentage of men > 75 years of age).
  • Whole-gland cryotherapy appears to have a relatively low risk for post-treatment incontinence (although validation of this through appropriate questionnaire-based data would be helpful).

It has been noted by others that a subset of men > 75 years of age who are diagnosed with localized prostate cancer are at significant risk for metastasis and prostate cancer-specific mortality if they do not receive early therapy. First-line, whole-gland cryotherapy would certainly seem to be a reasonable option for such men, particularly those who are already no longer sexually active.

The “New” Prostate Cancer InfoLink would like to thank Dr. Stephen Jones of The Cleveland Clinic for kindly providing us with the full text of this paper for review.

One Response

  1. As I finished reading this report, I had come to the same conclusion as the Sitemaster. Cryoablation appears to be a very reasonable form of treatment for men at and above the 75 years age level as long as the patient and spouse/partner are fully explained the consequent side effects — particularly impotence — that will result.

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