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Clinical Trial
. 2021 Apr 1;109(5):1254-1262.
doi: 10.1016/j.ijrobp.2020.11.009. Epub 2020 Nov 21.

Hypofractionated Postprostatectomy Radiation Therapy for Prostate Cancer to Reduce Toxicity and Improve Patient Convenience: A Phase 1/2 Trial

Nolan A Wages  1 , Jason C Sanders  2 , Amy Smith  2 , Songserea Wood  2 , Mitchell S Anscher  3 , Nikole Varhegyi  4 , Tracey L Krupski  5 , Timothy J Harris  3 , Timothy N Showalter  2
Affiliations
Clinical Trial

Hypofractionated Postprostatectomy Radiation Therapy for Prostate Cancer to Reduce Toxicity and Improve Patient Convenience: A Phase 1/2 Trial

Nolan A Wages et al. Int J Radiat Oncol Biol Phys. .

Abstract

Purpose: The phase 1 portion of this multicenter, phase 1/2 study of hypofractionated (HypoFx) prostate bed radiation therapy (RT) as salvage or adjuvant therapy aimed to identify the shortest dose-fractionation schedule with acceptable toxicity. The phase 2 portion aimed to assess the health-related quality of life (QoL) of using this HypoFx regimen.

Methods and materials: Eligibility included standard adjuvant or salvage prostate bed RT indications. Patients were assigned to receive 1 of 3 daily RT schedules: 56.6 Gy in 20 Fx, 50.4 Gy in 15 Fx, or 42.6 Gy in 10 Fx. Regional nodal irradiation and androgen deprivation therapy were not allowed. Participants were followed for 2 years after treatment with outcome measures based on prostate-specific antigen levels, toxicity assessments (Common Terminology Criteria for Adverse Events, v4.0), QoL measures (the Expanded Prostate Cancer Index Composite [EPIC] and EuroQol EQ-5D instruments), and out-of-pocket costs.

Results: There were 32 evaluable participants, and median follow-up was 3.53 years. The shortest dose-fractionation schedule with acceptable toxicity was determined to be 42.6 Gy in 10 Fx, with most patients (23) treated with this schedule. Grade 3 genitourinary (GU) and gastrointestinal (GI) toxicities occurred in 3 patients and 1 patient, respectively. There was 1 grade 4 sepsis event. Higher dose to the hottest 25% of the rectum was associated with increased risk of grade 2+ GI toxicity; no dosimetric factors were found to predict for GU toxicity. There was a significant decrease in the mean bowel, but not bladder, QoL score at 1 year compared with baseline. Prostate-specific antigen failure occurred in 34.3% of participants, using a definition of nadir plus 2 ng/mL. Metastases were more likely to occur in regional lymph nodes (5 of 7) than in bones (2 of 7). The mean out-of-pocket cost for patients during treatment was $223.90.

Conclusions: We identified 42.6 Gy in 10 fractions as the shortest dose-fractionation schedule with acceptable toxicity in this phase 1/2 study. There was a higher than expected rate of grade 2 to 3 GU and GI toxicity and a decreased EPIC bowel QoL domain with this regimen. Future studies are needed to explore alternative adjuvant/salvage HypoFx RT schedules after radical prostatectomy.

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Conflict of interest statement

Conflicts of interest: None

Figures

Figure 1:
Figure 1:
Dot and box plot of EPIC scores in urinary and bowel domains at baseline and 1 year after RT treatment at 4.26 Gy × 10 = 42.6 Gy [2 weeks].
Figure 2:
Figure 2:
Dot and box plot of EQ-5D scores in sexual and hormonal domains at baseline and 1 year after RT treatment at 4.26 Gy × 10 = 42.6 Gy [2 weeks].
Figure 3:
Figure 3:
Dot and box plot of EPIC scores in urinary and bowel domains at baseline and 2 years after RT treatment at 4.26 Gy × 10 = 42.6 Gy [2 weeks].
Figure 4:
Figure 4:
Dot and box plot of EPIC scores in sexual and hormonal domains at baseline and 2 years after RT treatment at 4.26 Gy × 10 = 42.6 Gy [2 weeks].
See this image and copyright information in PMC

Comment in

  • In Regard to Wages et al and Leite et al.
    Fiorino C, Cozzarini C, Fodor A, di Muzio NG. Fiorino C, et al. Int J Radiat Oncol Biol Phys. 2021 Aug 1;110(5):1548-1549. doi: 10.1016/j.ijrobp.2021.04.045. Int J Radiat Oncol Biol Phys. 2021. PMID: 34273332 No abstract available.
  • In Reply to Fiorino et al.
    Leite ETT, Ramos CCA, Moraes FY. Leite ETT, et al. Int J Radiat Oncol Biol Phys. 2021 Aug 1;110(5):1549-1550. doi: 10.1016/j.ijrobp.2021.04.046. Int J Radiat Oncol Biol Phys. 2021. PMID: 34273333 No abstract available.

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