1. RTOG 0126
A Phase III Randomized Study of High Dose 3D-CRT/IMRT versus Standard Dose 3D-CRT/IMRT in Patients Treated for Localized Prostate Cancer
Bijoy Anand July 2017 University of Wisconsin - LaCrosse Medical Dosimetry Program

2. Outline About RTOG Prostate Cancer Purpose Protocol
Inclusion/Exclusion
Who benefits? How?
Regimen
Planning
Conclusion

3. RTOG - History Radiation Therapy Oncology Group Organized in 1968
NCI-funded cooperative group (1971)
Became a foundation (1997)
Non-profit (2013)
Restructured as a part of NRG (2014)
Activated over 500 protocols, accrued >111,000 patients, published >1000 papers

4. Prostate Cancer The most common cancer in men Slow growing
5th leading cause of cancer-related death in men globally
Risk Factors – Age, Obesity, Family history
Avg age = 70; Majority > 65; 25% cases > 75
Adenocarcinoma – neoplasia of epithelial tissue
Common Modes of treatment
Active surveillance
Surgery
Radiation Therapy (including Brachytherapy)
Hormone Therapy

5. Purpose of RTOG 0126
Primary: To compare the effects of standard dose of 70.2 Gy (1.8 Gy x 39 Fx) versus higher dose of 79.2 Gy (1.8 Gy x 39 Fx) in patients with localized intermediate risk prostate cancer
Secondary:
Collect dose/volume data for TCP and NTCP modeling
Determine and compare the incidence of grade 2 or higher genito-urinary (GU) and gastro-intestinal (GI) acute and late toxicity
Collect quality of life data, including sexual function, to compare outcomes between the two treatment groups
Collect diagnostic biopsy samples
Collect paraffin-embedded tissue blocks, plasma, serum, and buffy- coat cells for future translational research

6. Eligibility
Histologically confirmed prostate adenocarcinoma within 180 days of randomization
Zubrod Performance Score of 0 or 1
Prostatic biopsy tumor grade by the Gleason Score
One of the following combination of factors:
Clinical Stage T1b – T2b, Gleason score 7, and Prostate Specific Antigen (PSA) < 15, or
Stage T1b – T2b, Gleason score 2-6, and PSA between 10-20

7. Exclusion Criteria Evidence of distant metastases
Regional lymph node involvement
Previous radical surgery (prostatectomy) or cryosurgery for prostate cancer
Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
Previous hormonal therapy
Previous or concurrent cytotoxic chemotherapy
Previous or concurrent invasive cancers (except skin cancer)
Major medical or psychiatric illness

8. Protocol Description RTOG Phase III Randomized trial
Phase III studies allow direct comparison of a standard treatment with a new treatment’s effectiveness, safety, and tolerability
2 trial arms:
Control group = 70.2 Gy in 39 fractions;
Experimental group = 79.2 Gy in 44 fractions;
Required/target accrual 1520, over 5-year period
13 year study
Now closed to accrual

9. Tx Regimen GTV = Prostate CTV = Prostate + proximal BSV*
PTV = CTV + ( cm) margin for set-up and internal organ motion
3D-CRT or IMRT using 6MV or higher
1.8 Gy daily fractions, 5 days/week
Rx dose: > 98% to PTV, >100% to CTV
*BSV = bilateral seminal vesicles. The proximal seminal vesicle is defined as the portion from its origin
with the prostate and extending 1.0 cm superiorly

10. Treatment Regimen Dose Goal Arm 1 70.2 Gy 75.1 Gy 77.2 Gy >77.2 Gy
(Prescription)
Minimum PTV dose encompassing ≥ 98% of PTV
Minimum CTV dose encompassing ≥ 100% of CTV
Maximum PTV dose to
≤ 2% of PTV1
(No variation)
(Minor variation)
(Major variation)
Arm 1
70.2 Gy
75.1 Gy
77.2 Gy
>77.2 Gy
Arm 2
79.2 Gy
84.7 Gy
87.1 Gy
>87.1 Gy
1 The maximum dose must not be within an “Organ at Risk” such as the Rectum, Bladder, or Penile Bulb