Hypofractionated stereotactic boost in intermediate risk prostate carcinoma: Preliminary results of a multicenter phase II trial (CKNO-PRO)

David Pasquier, Philippe Nickers, Didier Peiffert, Philippe Maingon, Pascal Pommier, Thomas Lacornerie, Geoffrey Martinage, Emmanuelle Tresch, Eric Lartigau, David Pasquier, Philippe Nickers, Didier Peiffert, Philippe Maingon, Pascal Pommier, Thomas Lacornerie, Geoffrey Martinage, Emmanuelle Tresch, Eric Lartigau

Abstract

Purpose: Dose escalation may improve curability in intermediate-risk prostate carcinoma. A multicenter national program was developed to assess toxicity and tumor response with hypofractionated stereotactic boost after conventional radiotherapy in intermediate-risk prostate cancer.

Methods and material: Between August 2010 and April 2013, 76 patients with intermediated-risk prostate carcinoma were included in the study. A first course delivered 46 Gy by IMRT (68.4% of patients) or 3D conformal radiotherapy (31.6% of patients). The second course delivered a boost of 18 Gy (3x6Gy) within 10 days. Gastrointestinal (GI) and genitourinary (GU) toxicities were evaluated as defined by NCI-CTCAE (v4.0). Secondary outcome measures were local control, overall and metastasis-free survival, PSA kinetics, and patient functional status (urinary and sexual) according to the IIEF5 and IPSS questionnaires.

Results: The overall treatment time was 45 days (median, range 40-55). Median follow-up was 26.4 months (range, 13.6-29.9 months). Seventy-seven per cent (n = 58) of patients presented a Gleason score of 7. At 24 months, biological-free survival was 98.7% (95% CI, 92.8-99.9%) and median PSA 0.46 ng/mL (range, 0.06-6.20 ng/mL). Grade ≥2 acute GI and GU toxicities were 13.2% and 23.7%, respectively. Grade ≥2 late GI and GU toxicities were observed in 6.6% and 2.6% of patients, respectively. No grade 4 toxicity was observed.

Conclusions: Hypofractionated stereotactic boost is effective and safely delivered for intermediate-risk prostate carcinoma after conventional radiation. Mild-term relapse-free survival and tolerance results are promising, and further follow-up is warranted to confirm the results at long term.

Trial registration: ClinicalTrials.gov NCT01596816.

Conflict of interest statement

Competing Interests: Eric Lartigau reports personal fees from ACCURAY outside the submitted work and Research Grants from Acurray Inc. All other authors have no conflict of interest to declare. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

Figures

Fig 1. Flowchart diagram of the study.
Fig 1. Flowchart diagram of the study.
Fig 2. Actuarial cumulative incidence of grade…
Fig 2. Actuarial cumulative incidence of grade ≥ 2 late gastrointestinal toxicities (CTCAE v4.0).
Fig 3. PSA at baseline, during radiotherapy…
Fig 3. PSA at baseline, during radiotherapy treatment and during follow-up.

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