Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.
ADVANCED SEARCH
Log in
Top
Radiation Oncology
Published in: Radiation Oncology 1/2020

Open Access 01-12-2020 | Prostate Cancer | Research

Phase I/IIa trial of androgen deprivation therapy, external beam radiotherapy, and stereotactic body radiotherapy boost for high-risk prostate cancer (ADEBAR)

Authors: Yeon Joo Kim, Hanjong Ahn, Choung-Soo Kim, Young Seok Kim

Published in: Radiation Oncology | Issue 1/2020

Login to get access

Abstract

Background

To evaluate the clinical outcomes of combination of androgen deprivation therapy (ADT), whole pelvic radiotherapy (WPRT), and stereotactic body radiotherapy (SBRT) boost in high-risk prostate cancer patients.

Methods

This prospective phase I/IIa study was conducted between 2016 and 2017. Following WPRT of 44 Gy in 20 fractions, patients were randomized to two boost doses, 18 Gy and 21 Gy, in 3 fractions using the Cyberknife system. Primary endpoints were incidences of acute toxicities and short-term biochemical recurrence-free survival (BCRFS). Secondary endpoints included late toxicities and short-term clinical progression-free survival (CPFS).

Results

A total of 26 patients were enrolled. Twelve patients received a boost dose of 18 Gy, and the rest received 21 Gy. The Median follow-up duration was 35 months. There were no grade ≥ 3 genitourinary (GU) or gastrointestinal (GI) toxicities. Sixty-one and 4% of patients experienced grade 1–2 acute GU and GI toxicities, respectively. There were 12% late grade 1–2 GU toxicities and 8% late grade 1–2 GI toxicities. Patient-reported outcomes of urinary symptoms were aggravated after WPRT and SBRT boost. However, they resolved at 1 month and returned to the baseline level at 4 months. Three-year BCRFS was 88.1%, and CPFS was 92.3%.

Conclusions

The present study protocol demonstrated that the combination of ADT, WPRT, and SBRT boosts for high-risk prostate cancer is safe and feasible, and may reduce total treatment time to 5 weeks. Boost dose of 21 Gy in 3 fractions seems appropriate.

Trial registration

ClinicalTrials.gov, ID; NCT03322020 - Retrospectively registered on 26 October 2017.
Literature
1.
Zietman AL, DeSilvio ML, Slater JD, Rossi CJ Jr, Miller DW, Adams JA, et al. Comparison of conventional-dose vs high-dose conformal radiation therapy in clinically localized adenocarcinoma of the prostate: a randomized controlled trial. JAMA. 2005;294(10):1233–9.PubMedCrossRef
2.
Peeters ST, Heemsbergen WD, Koper PC, van Putten WL, Slot A, Dielwart MF, et al. Dose-response in radiotherapy for localized prostate cancer: results of the Dutch multicenter randomized phase III trial comparing 68 Gy of radiotherapy with 78 Gy. J Clin Oncol. 2006;24(13):1990–6.PubMedCrossRef
3.
Brenner DJ, Hall EJ. Fractionation and protraction for radiotherapy of prostate carcinoma. Int J Radiat Oncol Biol Phys. 1999;43(5):1095–101.PubMedCrossRef
4.
King MT, Yang DD, Muralidhar V, Mahal B, Butler S, Devlin PM, et al. A comparative analysis of overall survival between high-dose-rate and low-dose-rate brachytherapy boosts for unfavorable-risk prostate cancer. Brachytherapy. 2019;18(2):186–91.PubMedCrossRef
5.
6.
Fuller DB, Naitoh J, Lee C, Hardy S, Jin HJ. Virtual HDRSM CyberKnife treatment for localized prostatic carcinoma: dosimetry comparison with HDR brachytherapy and preliminary clinical observations. Int J Radiat Oncol Biol Phys. 2008;70(5):1588–97.PubMedCrossRef
7.
Mercado C, Kress M-A, Cyr RA, Chen LN, Yung TM, Bullock EG, et al. Intensity-modulated radiation therapy with stereotactic body radiation therapy boost for unfavorable prostate cancer: the Georgetown University experience. Front Oncol. 2016;6:114.PubMedPubMedCentralCrossRef
8.
Katz A, Kang J. Stereotactic body radiotherapy with or without external beam radiation as treatment for organ confined high-risk prostate carcinoma: a six year study. Radiat Oncol. 2014;9(1):1.PubMedPubMedCentralCrossRef
9.
Anwar M, Weinberg V, Seymour Z, Hsu IJ, Roach M, Gottschalk AR. Outcomes of hypofractionated stereotactic body radiotherapy boost for intermediate and high-risk prostate cancer. Radiat Oncol. 2016;11(1):8.PubMedPubMedCentralCrossRef
10.
Lin Y-W, Lin L-C, Lin K-L. The early result of whole pelvic radiotherapy and stereotactic body radiotherapy boost for high-risk localized prostate cancer. Front Oncol. 2014;4:278.PubMedPubMedCentralCrossRef
11.
Kim HJ, Phak JH, Kim WC. Clinical outcomes of whole pelvis radiotherapy and stereotactic body radiotherapy boost for intermediate- and high-risk prostate cancer. Asia Pac J Clin Oncol. 2017;13(5):e342–e7.PubMedCrossRef
12.
Pasquier D, Peiffert D, Nickers P, Maingon P, Pommier P, Lacornerie T, et al. A Multicenter Phase 2 study of Hypofractionated Stereostatic Boost in Intermediate Risk Prostate Carcinoma: A 5-Year Analysis of the CKNO-PRO Trial. Int J Radiat Oncol Biol Phys. 2020;106(1):116–23.PubMedCrossRef
13.
Kim YJ, Ahn H, Kim C-S, Lee J-L, Kim YS. Stereotactic body-radiotherapy boost dose of 18 Gy vs 21 Gy in combination with androgen-deprivation therapy and whole-pelvic radiotherapy for intermediate-or high-risk prostate cancer: a study protocol for a randomized controlled, pilot trial. Trials. 2018;19(1):212.PubMedPubMedCentralCrossRef
14.
Bolla M, Van Tienhoven G, Warde P, Dubois JB, Mirimanoff R-O, Storme G, et al. External irradiation with or without long-term androgen suppression for prostate cancer with high metastatic risk: 10-year results of an EORTC randomised study. Lancet Oncol. 2010;11(11):1066–73.PubMedCrossRef
15.
Lee SU, Cho KH. Multimodal therapy for locally advanced prostate cancer: the roles of radiotherapy, androgen deprivation therapy, and their combination. Radiat Oncol J. 2017;35(3):189–97.PubMedPubMedCentralCrossRef
16.
17.
Joseph D, Denham JW, Steigler A, Lamb DS, Spry NA, Stanley J, et al. Radiation dose escalation or longer androgen suppression to prevent distant progression in men with locally advanced prostate cancer: 10-year data from the TROG 03.04 RADAR trial. Int J Radiat Oncol Biol Phys. 2020;106(4):693–702.PubMedCrossRef
18.
Pryor D, Sidhom M, Arumugam S, Bucci J, Gallagher S, Smart J, et al. Phase 2 Multicentre Study of Gantry-Based Stereotactic Radiotherapy Boost for Intermediate and High Risk Prostate Cancer (PROMETHEUS). Front Oncol. 2019;9:217.PubMedPubMedCentralCrossRef
19.
Tritschler S, Roosen A, Füllhase C, Stief CG, Rübben H. Urethral stricture: etiology, investigation and treatments. Dtsch Arztebl Int. 2013;110(13):220–6.PubMedPubMedCentral
20.
Pommier P, Chabaud S, Lagrange J-L, Richaud P, Le Prise E, Wagner J-P, et al. Is there a role for pelvic irradiation in localized prostate adenocarcinoma? Update of the long-term survival results of the GETUG-01 randomized study. Int J Radiat Oncol Biol Phys. 2016;96(4):759–69.PubMedCrossRef
21.
Tharmalingam H, Tsang Y, Choudhury A, Alonzi R, Wylie J, Ahmed I, et al. External beam radiation therapy (EBRT) and high-dose-rate (HDR) brachytherapy for intermediate and high-risk prostate cancer: The impact of EBRT volume. Int J Radiat Oncol Biol Phys. 2020;106(3):525–33.PubMedCrossRef
22.
Morris WJ, Tyldesley S, Rodda S, Halperin R, Pai H, McKenzie M, et al. Androgen Suppression Combined with Elective Nodal and Dose Escalated Radiation Therapy (the ASCENDE-RT Trial): An Analysis of Survival Endpoints for a Randomized Trial Comparing a Low-Dose-Rate Brachytherapy Boost to a Dose-Escalated External Beam Boost for High- and Intermediate-risk Prostate Cancer. Int J Radiat Oncol Biol Phys. 2017;98(2):275–85.PubMedCrossRef
23.
Miralbell R, Roberts SA, Zubizarreta E, Hendry JH. Dose-fractionation sensitivity of prostate cancer deduced from radiotherapy outcomes of 5,969 patients in seven international institutional datasets: alpha/beta = 1.4 (0.9-2.2) Gy. Int J Radiat Oncol Biol Phys. 2012;82(1):e17–24.PubMedCrossRef
24.
Mitin T, Henry A, Choudhury A, Chen RC, Pinkawa M, Spratt DE. SBRT for Localized Prostate Cancer: Is it Ready for Take-Off? Int J Radiat Oncol Biol Phys. 2019;105(3):618–20.PubMedCrossRef
25.
King CR. The dose–response of salvage radiotherapy following radical prostatectomy: A systematic review and meta-analysis. Radiother Oncol. 2016;121(2):199–203.PubMedCrossRef
Metadata
Title
Phase I/IIa trial of androgen deprivation therapy, external beam radiotherapy, and stereotactic body radiotherapy boost for high-risk prostate cancer (ADEBAR)
Authors
Yeon Joo Kim
Hanjong Ahn
Choung-Soo Kim
Young Seok Kim
Publication date
01-12-2020
Publisher
BioMed Central
Published in
Radiation Oncology / Issue 1/2020
Electronic ISSN: 1748-717X
DOI
https://doi.org/10.1186/s13014-020-01665-6

Other articles of this Issue 1/2020

Radiation Oncology 1/2020 Go to the issue

Research

The impact of scanning data measurements on the Acuros dose calculation algorithm configuration

Research

Feasibility of hippocampus-sparing VMAT for newly diagnosed glioblastoma treated by chemoradiation: pattern of failure analysis

Research

Accuracy of real-time respiratory motion tracking and time delay of gating radiotherapy based on optical surface imaging technique

Research

Validation of the graded prognostic assessment for gastrointestinal cancers with brain metastases (GI-GPA)

Research

Dosimetric benefit of an adaptive treatment by means of plan selection for rectal cancer patients in both short and long course radiation therapy

Research

Patterns of recurrence in anal cancer: a detailed analysis