Highlights
- •Results of a multi-institutional study of stereotactic body radiation therapy for prostate cancer are reported.
- •Doses up to 47.5 Gy in five fractions resulted in high control with acceptable toxicity.
- •Fifty gray in five fractions was associated with an increase in late high grade toxicity.
- •Three and five year biochemical control rates are 100 and 98.6% respectively.
Abstract
Background
We report the outcome of a phase I/II clinical trial of stereotactic body radiation
therapy (SBRT) for low (LR) and select intermediate risk (IR) prostate cancer (PCa)
patients.
Patients and methods
Eligible patients included men with prostate adenocarcinoma with Gleason score 6 with
PSA ≤ 20 or Gleason 7 with PSA ≤ 15 and clinical stage ≤ T2b. For the phase I portion
of the study patients in cohorts of 15 received 45, 47.5, or 50 Gray (Gy) in five
fractions. Since the maximally tolerated dose was not met in the phase I study, an
additional 47 patients received 50 Gy in five fractions in the phase II study. Toxicity
using Common Toxicity Criteria for Adverse Events v. 3.0, quality of life, and outcome
data was collected.
Results
A total of 91 patients are included for analysis; 63.7% had NCCN IR and 36.3% had
LR PCa. At a median follow up of 54 months the actuarial freedom from biochemical
failure was 100% at 3 years and 98.6% at 5 years. Actuarial distant metastasis free
survival was 100% at 3 and 5 years. Overall survival was 94% at 3 years and 89.7%
at 5 years with no deaths attributed to PCa. Acute and late urinary grade ≥ III toxicity
occurred in 0% and 5.5% of patients, respectively. Gastrointestinal (GI) acute and
late toxicity of grade ≥ III occurred in 2% and 7% of patients, respectively. A total
of four men experienced grade IV toxicity (three GI, one genitourinary).
Conclusion
SBRT treatment results in excellent biochemical control rates at 5 years for LR and
IR PCa patients although doses greater than 47.5 Gy in five fractions led to increased
severe late toxicity.
Keywords
To read this article in full you will need to make a payment
Purchase one-time access:
Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online accessOne-time access price info
- For academic or personal research use, select 'Academic and Personal'
- For corporate R&D use, select 'Corporate R&D Professionals'
Subscribe:
Subscribe to European Journal of CancerAlready a print subscriber? Claim online access
Already an online subscriber? Sign in
Register: Create an account
Institutional Access: Sign in to ScienceDirect
References
- Carcinoma of prostate treated by radical external beam radiotherapy using hypofractionation. Twenty-two years' experience (1962–1984).Urology. 1990; 36: 107-111
- Long-term outcomes from a prospective trial of stereotactic body radiotherapy for low-risk prostate cancer.Int J Radiat Oncol Biol Phys. 2012; 82: 877-882
- Stereotactic hypofractionated accurate radiotherapy of the prostate (SHARP), 33.5 Gy in five fractions for localized disease: first clinical trial results.Int J Radiat Oncol Biol Phys. 2007; 67: 1099-1105
- What is the alpha/beta ratio for prostate cancer? Rationale for hypofractionated high-dose-rate brachytherapy.Int J Radiat Oncol Biol Phys. 1999; 44: 747-748
- What hypofractionated protocols should be tested for prostate cancer?.Int J Radiat Oncol Biol Phys. 2003; 56: 1093-1104
- Prostate alpha/beta revisited – an analysis of clinical results from 14 168 patients.Acta Oncol. 2012; 51: 963-974
- Action of X-rays on mammalian cells.J Exp Med. 1956; 103: 653-666
- Universal survival curve and single fraction equivalent dose: useful tools in understanding potency of ablative radiotherapy.Int J Radiat Oncol Biol Phys. 2008; 70: 847-852
- Efficacy of high dose per fraction radiation for implanted human prostate cancer in a nude mouse model.J Urol. 2006; 175: 1932-1936
- Phase II prospective study of the use of conformal high-dose-rate brachytherapy as monotherapy for the treatment of favorable stage prostate cancer: a feasibility report.Int J Radiat Oncol Biol Phys. 2001; 49: 61-69
- High-Dose-Rate Brachytherapy as Monotherapy for Intermediate- and High-Risk Prostate Cancer: Clinical Results for a Median 8-Year Follow-Up.Int J Radiat Oncol Biol Phys. 2015;
- Phase I dose-escalation study of stereotactic body radiation therapy for low- and intermediate-risk prostate cancer.J Clin Oncol. 2011; 29: 2020-2026
- Predictors of rectal tolerance observed in a dose-escalated phase 1-2 trial of stereotactic body radiation therapy for prostate cancer.Int J Radiat Oncol Biol Phys. 2014; 89: 509-517
- Defining biochemical failure following radiotherapy with or without hormonal therapy in men with clinically localized prostate cancer: recommendations of the RTOG-ASTRO Phoenix Consensus Conference.Int J Radiat Oncol Biol Phys. 2006; 65: 965-974
- Stereotactic body radiotherapy for localized prostate cancer: interim results of a prospective phase II clinical trial.Int J Radiat Oncol Biol Phys. 2009; 73: 1043-1048
- Consensus statement: guidelines for PSA following radiation therapy. American Society for Therapeutic Radiology and Oncology Consensus Panel.Int J Radiat Oncol Biol Phys. 1997; 37: 1035-1041
- 6-month androgen suppression plus radiation therapy vs radiation therapy alone for patients with clinically localized prostate cancer: a randomized controlled trial.JAMA. 2004; 292: 821-827
- Comparison of hypofractionated high-dose intensity-modulated radiotherapy schedules for prostate cancer: results from the phase III randomized CHHiP trial (CRUK/06/016). in Genitourinary Cancers Symposium. 2016. San Fransico, CA.J Clin Oncol. 2016; 34 (suppl 2S; abstr 2)
- Stereotactic body radiation therapy (SBRT) for clinically localized prostate cancer: the Georgetown University experience.Radiat Oncol. 2013; 8: 58
- Stereotactic body radiotherapy as treatment for organ confined low- and intermediate-risk prostate carcinoma, a 7-year study.Front Oncol. 2014; 4: 240
- A randomized trial of 79.2Gy versus 70.2Gy radiation therapy (RT) for localized prostate cancer.J Clin Oncol. 2015; 33 (abstr 4)
- 70 Gy versus 80 Gy in localized prostate cancer: 5-year results of GETUG 06 randomized trial.Int J Radiat Oncol Biol Phys. 2011; 80: 1056-1063
- Long-term biochemical disease-free and cancer-specific survival following anatomic radical retropubic prostatectomy. The 15-year Johns Hopkins experience.Urol Clin North Am. 2001; 28: 555-565
- NRG Oncology RTOG 0415: a Randomized Phase 3 Noninferiority Study Comparing 2 Fractionation Schedules in Patients with Low-Risk Prostate Cancer.Int J Radiat Oncol Biol Phys. January 2016; 94: 3-4
- Multi-institutional registry for prostate cancer radiosurgery: a prospective observational clinical trial.Front Oncol. 2014; 4: 369
- Stereotactic body radiation therapy for the primary treatment of localized prostate cancer.J Radiat Oncol. 2013; 2: 63-70
- Prostate stereotactic body radiotherapy-first UK experience.Clin Oncol (R Coll Radiol). 2014; 26: 757-761
- Hypofractionated stereotactic body radiotherapy in low-risk prostate adenocarcinoma: preliminary results of a multi-institutional phase 1 feasibility trial.Cancer. 2012; 118: 3681-3690
- Comparison of high-dose (86.4 Gy) IMRT vs combined brachytherapy plus IMRT for intermediate-risk prostate cancer.BJU Int. 2014; 114: 360-367
- Stereotactic body radiation therapy versus intensity-modulated radiation therapy for prostate cancer: comparison of toxicity.J Clin Oncol. 2014; 32: 1195-1201
- Improved clinical outcomes with high-dose image guided radiotherapy compared with non-IGRT for the treatment of clinically localized prostate cancer.Int J Radiat Oncol Biol Phys. 2012; 84: 125-129
- Treatment outcome of high-dose image-guided intensity-modulated radiotherapy using intra-prostate fiducial markers for localized prostate cancer at a single institute in Japan.Radiat Oncol. 2012; 7: 105
- Low rectal toxicity after dose escalated IMRT treatment of prostate cancer using an absorbable hydrogel for increasing and maintaining space between the rectum and prostate: results of a multi-institutional phase II trial.Radiother Oncol. 2013; 106: 215-219
- Stereotactic body radiotherapy with a focal boost to the MRI-visible tumor as monotherapy for low- and intermediate-risk prostate cancer: early results.Radiat Oncol. 2013; 8: 84
- How good is MRI at detecting and characterising cancer within the prostate?.Eur Urol. 2006; 50 (discussion 75): 1163-1174
- Single blind randomized phase III trial to investigate the benefit of a focal lesion ablative microboost in prostate cancer (FLAME-trial): study protocol for a randomized controlled trial.Trials. 2011; 12: 255
- Urinary and sexual function after radical prostatectomy for clinically localized prostate cancer: the Prostate Cancer Outcomes Study.JAMA. 2000; 283: 354-360
- Lower urinary tract symptoms, urinary incontinence, sexual function and quality of life after radical prostatectomy and external beam radiation therapy: real life experience in Austria.World J Urol. 2006; 24: 325-330
- Sexual function before and after radical retropubic prostatectomy: a systematic review of prognostic indicators for a successful outcome.Eur Urol. 2006; 50 (discussion 18–20): 711-718
- Potency preservation following stereotactic body radiation therapy for prostate cancer.Radiat Oncol. 2013; 8: 256
- Health-related quality of life after stereotactic body radiation therapy for localized prostate cancer: results from a multi-institutional consortium of prospective trials.Int J Radiat Oncol Biol Phys. 2013; 87: 939-945
Article info
Publication history
Published online: March 29, 2016
Accepted:
February 13,
2016
Received in revised form:
January 28,
2016
Received:
November 19,
2015
Footnotes
☆Supported by a Clinical Trial Award from the US Department of Defense (grant no. PC061629; R.T., principal investigator). Registered at Clinicaltrials.gov study number NCT00547339.
Identification
Copyright
© 2016 Elsevier Ltd. All rights reserved.