Salvage Cryoablation Following RT Failure
For individuals with locally recurrent prostate cancer, salvage cryotherapy has become a preferred treatment option with curative potential.
Aaron E. Katz, MD, professor of urology and an early pioneer of the technique, explains that while therapy for patients with radiation-recurrent disease needs to be individualized, salvage cryoablation is often a treatment of choice for patients in this setting.
“Cryotherapy ablates all tissue in a targeted area, which allows us to freeze and destroy tissue beyond the confines of the prostate gland, offering an advantage compared to other treatment options,” says Dr. Katz.
“We were instrumental in the Medicare coverage determination process for salvage crytotherapy in this setting. It remains an established option for patients with radiation-recurrent disease.”
Aaron E. Katz, MD
Importance of PSA Monitoring
Monitoring prostate-specific antigen (PSA) after treatment of localized disease can lead to the detection of biochemical recurrence. In many cases, rises in serum PSA above baseline do not co-occur with symptoms of recurrent prostate cancer.
“For patients with a confirmed rise in serum PSA after prior definitive RT, careful assessment is required to rule out distant metastases,” says Dr. Katz.
In the last 5 years, the use of novel PET/CT imaging modalities such as the Axumin® (fluciclovine F 18) and PYLARIFY® (piflufolastat F 18) scans have dramatically improved the detection of recurrent disease. Both imaging technologies are available at NYU Langone.
“After detection of recurrent disease, the goal of salvage cryotherapy is to delay initiation of androgen deprivation therapy (ADT), which can have deleterious side effects,” explains Dr. Katz.
Better Outcomes, Covered by Medicare
The 5- and 10-year disease-specific survival rates following salvage cryoablation are 91% and 79%, respectively. In addition, the procedure is covered under Medicare for patients with localized disease who have failed a trial of radiation therapy as their primary treatment and meet other conditions.
Furthermore, current guidelines from the American Urological Association (AUA) support cryotherapy as an option in this setting.
“We were instrumental in the Medicare coverage determination process for salvage crytotherapy in this setting,” says Dr. Katz. “It remains an established option for patients with radiation-recurrent disease.”
How Does Cryotherapy Work?
Schematic illustration of cryotherapy. ADAPTED FROM: World J Urol. 2019;37(3):409-418.
Cryotherapy causes tissue damage and vascular injury around the cryoneedle.
- The cryotherapy device consists of an ultrasound-guided system, 17-gauge cryoneedles, thermocouples, and argon and helium inlets.
- The procedure consists of two freeze and thaw cycles.
- The procedure can take place in an outpatient setting under spinal anesthesia.
- Magnetic resonance (MR)-guided cryotherapy has proved to allow for real-time imaging of the ablated zone by active monitoring.
A Treatment with Curative Potential
Cryotherapy being performed in an operating room.
For patients with locally recurrent prostate cancer, cryoablation offers the potential for cure. Other salvage treatment options for patients with a positive prostate biopsy, without evidence of metastatic disease, include radical prostatectomy and brachytherapy. However, cryotherapy offers unique advantages compared to these approaches.
Benefits of Salvage Cryoablation
MRI 12 months following salvage cryotherapy. Red arrow indicates area of ablation.
- No hospital stay
- No transfusions
- No delayed/long-term complications
- No risk of secondary malignancy
- Repeatable
- Low incontinence rates
- Minimal anesthesia
- Quick return to “normal life”
Covered by Medicare, Recommended by Guidelines
A cryotherapy probe.
Medicare covers cryosurgical salvage therapy for patients with localized disease who:
(1) have failed a trial of radiation therapy as their primary treatment; and
(2) meet one of the following conditions: Stage T2B or below, Gleason score < 9, PSA < 8 ng/mL.
Current guidelines from the American Urological Association (AUA) also support cryotherapy as an option for patients.
Additional Clinical Trials for Localized Prostate Cancer
In collaboration with Dana-Farber Cancer Institute, Aaron E. Katz, MD, is leading the INTREPId clinical trial evaluating whether darolutamide plus radiation therapy (RT) is non-inferior to GnRH agonist and bicalutamide plus RT for intermediate risk prostate cancer.
“The goal of this trial is to determine whether men who receive darolutamide and RT are better able to preserve erectile function without sacrificing the potential for long-term disease control,” says Dr. Katz.
