Table 1.
Oncologic outcomes of recent whole-gland salvage cryotherapy trials
| Study | Patients, n | Follow-up, mo | Cryounit/cycles | cStage at RT | Gleason at cryo | Med pre-RT, and precryo PSA, ng/mL | Failure definition | ADT | Post-treatment biopsy,% + | bNED,% |
|---|---|---|---|---|---|---|---|---|---|---|
| Williams et al. [16•] | 187 | 90 | Candella, cryocare, FT 2x | ≤ T2: 86.1%; ≥ T3: 13.9% | GS 6–7: 60.7%; GS ≥ 8: 39.3% | 11.0, 4.9 | Phoenix | 71% neo, 32% adjuvant | 6, 12, 24 mo (n = 178): 16.7 | 64 DSS (10 y); 39 DFS; 87 OS |
| Pisters et al. [37] | 279 | 21.6 | Cryocare | NR | GS 6–7: 51.2%; GS ≥8: 43.7% | NR, 7.6 | ASTRO & Phoenix | 50.9% neo, 8.2% adjuvant | MD discretion, (n = 46, 16.5%): 32.6 | 58.9 & 54.5 (5 y) |
| Donnelly et al. [38] | 46 | NR | Multi | ≤ T2: 86.9%; ≥T3: 13% | GS 6–7: 58.7%; GS ≥8: 41.3% | 19.2, 5.6 | Nadir +0.2 2x or >1.0 | 15.2% neo | MD discretion (n = NR) | ~50 (3.3 y) |
| Ismail et al. [36] | 100 | 33.5 | Cryocare, SeedNetb | ≤ T2: 70%; ≥ T3: 30% | GS 6–7: 63.0%; GS ≥8: 37.0% | NR, 5.4 | ASTRO & PSA <0.5 ng/mL | 22% neo, 24% adjuvant | PSA progression | 59 (3 y) |
| Cheetham et al. [23] | 51 | 121 | 2nd or 3rd generation FT 2x | Unknown in 90.2% | GS 6–7: 53.2%; GS ≥8: 46.8% | NR, 6.4 | ASTRO & Phoenix | NR | NR | NR |
| Spiess et al. [21] | 450 | 40.8 | NR | ≤ T2: 67%; ≥ T3: 33% | GS 6–7: 82.7%; GS ≥8: 17.3% | 2.2 (mean), 7.8 (mean) | PSA >0.5 ng/mL | 38.1% neo, 0% adjuvant | NR | 34 |
| Bahn et al. [22] | 59 | 82.3 | NR, FT 2x | ≤ T2:69%; ≥T3: 29% | GS 6–7: 71%; GS ≥8: 29% | NR, 5.6 | Increase in PSA ≥0.5 ng/mL; 1.0 ng/mL | 0% adjuvant | 6, 12, 24, 60 mo if PSA rise or PSA >0.5 ng/mL (n = 38, 64.4%): 0 | 59 (0.5 ng/mL), 69 (PSA 1.0 ng/mL) |
| Han and Belldegrun [39] | 29 | NR | SeedNet, FT 2x | NR | NR | NR, NR | PSA ≤0.4 | NR | 12 mo | 72.2 |
| Eisenberg et al. [27]a | 15 | 18 | SeedNet, FT 2–4x | ≤ T2: 82.4%; ≥ T3: 17.6% | GS 6–7: 63.2%; GS ≥8: 36.8% | NR, 3.3 | ASTRO & Phoenix | NR | 12 mo (n = 66.7%): 10 | 50, 79 (3 y) |
aHemiablation
bManufactured by Galil Medical, Arden Hills, MN
ADT androgen deprivation therapy, ASTRO American Society for Therapeutic Radiology and Oncology, bNED biochemical no evidence of disease, cryo cryotherapy, DFS disease-free survival, DSS disease-specific survival, FT freeze/thaw, GS Gleason score, MD medical doctor, NR not reported, OS overall survival, PSA prostate-specific antigen, RT radiotherapy