Clinical Trials: Prostate Cancer

RTOG 0415:

A Phase III Randomized Study of Hypofractionated 3D-CRT/IMRT Versus Conventionally Fractionated 3D-CRT/IMRT in Patients with Favorable-Risk Prostate Cancer

Inclusion/Exclusion:

prostate adenocarcinoma, confirmed histologically <180 days prior to randomization; clinical stage T1-2c; pretreatment PSA <10 g/mL; Gleason score <7; no radical surgery or cryosurgery; no prior or planned androgen deprivation or bilateral orchiectomy

• Stratification by Gleason score, PSA, and radiation modality (3D-CRT vs. IMRT)
• Randomization to either 73.8 Gy (41 fractions/8.2 weeks) or 70 Gy (28 fractions/5.6 weeks)
• Follow-up every 3 months for two years and every 6 months for three years thereafter
• Mandatory path slide submission; optional additional biomarker studies and QOL study

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RTOG 0521:

A Phase III Protocol of Androgen Suppression (AS) and 3DCRT/IMRT vs. AS and 3DCRT/IMRT Followed by Chemotherapy with Docetaxel and Prednisone for Localized, High-Risk Prostate Cancer

Inclusion/Exclusion:

• Histologically confirmed N0M0 prostate cancer with one of the following combinations:
  • Gleason > 9, PSA < 150, and any T-stage
  • Gleason 8, PSA < 20, and > T2
  • Gleason 8, PSA > 20–150, and any T-stage
  • Gleason 7, PSA > 20–150, and any T-stage
• No prior prostatectomy, pelvic radiation, or bilateral orchiectomy

Details: Stratification by the combinations noted above, then randomization to one of two treatment arms:

• Both Arm 1 & Arm 2—AS (LHRH agonist and oral antiandrogen) x 8 weeks followed by RT to 72.0-75.6 Gy with concurrent AS.  LHRH will continue for a total of 24 months from initiation of any treatment.  Oral antiandrogen will be discontinued at the end of RT.
• Arm 2 Only—Six cycles (each 21 days) of docetaxel and prednisone delivered concurrently with AS beginning 28 days after completion of RT

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