Radiation Oncology/Prostate/Chemotherapy

Front Page: Radiation Oncology | RTOG Trials | Randomized Trials

RT + Brachy + TAS + Docetaxel

Protocol: 45 Gy pelvic EBRT + prostate brachytherapy + Docetaxel x 3 months + TAS x 2 years
Eligibility: T3/T4, or (GS 7 and PSA >10) or (GS 8-10 and PSA >7) without extrapelvic disease
Results: 36 patients, 20 months follow-up. No failures. Well tolerated.

RTOG 05-21 -- RT + ADT +/- docetaxel
- "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
- Pts: 1) Gleason >=9 and PSA <= 150, Any T stage, 2) Gleason 8, PSA <20, T2 or higher, 3) Gleason 7-8, PSA 20-150, Any T stage. Clinically negative LN.
- Arm 1: AS (LHRH agonist + oral antiandrogen) x 8 weeks, followed by RT to 72-75.6 Gy with concurrent AS. Continue LHRH for total of 24 months. Arm 2: Arm 1 plus 6 cycles of docetaxel (q3w) and daily prednisone 28 days after completion of RT.
- 2019 PMID 30860948 -- "Effect of Chemotherapy with Docetaxel with Androgen Suppression and Radiotherapy for Localized High-risk Prostate Cancer: The Randomized Phase III NRG Oncology RTOG 0521 Trial." (Rosenthal SA et al, J Clin Oncol. 2019 May 10;37(14):1159-1168)
  - 612 patients, median follow up 5.7 years
  - 4yr OS 89% AS+RT vs. 93% AS+RT+CT (HR 0.69, p=0.03)
  - 6yr DFS 55% AS+RT vs. 65% AS+RT+CT (HR 0.76, p=0.04)
  - 6yr DM 14% AS+RT vs. 9% AS+RT+CT (HR 0.60, p=0.04)
    - Fewer deaths due to prostate cancer/treatment and other causes in AS+RT+CT arm

Nihon University, Japan (2003-2006) -- RT + ADT +/- estramustine
- Randomized. 39 patients, intermediate/high risk PCA by NCCN guidelines. Arm 1) Neoadjuvant/concurrent LHRH agonist + estramustine x6 months vs Arm 2) NCAHT x 6 months. Both groups 3D-CRT 70/35
- 2010 PMID 19449118 -- "Neoadjuvant LHRH analog plus estramustine phosphate combined with three-dimensional conformal radiotherapy for intermediate- to high-risk prostate cancer: a randomized study." (Hirano D, Int Urol Nephrol. 2010 Mar;42(1):81-8. Epub 2009 May 16.) Median F/U 2.3 years
  - Outcome: 4-year bRFS ADT+EMP 61% vs ADT alone 49% (SS)
  - Toxicity: No severe toxicities
  - Conclusion: ADT + EMP better than ADT alone, but either arm insufficient and dose escalation or adjuvant ADT needed

RTOG 99-02 (2000-2004) -- RT + ADT +/- TEE (taxol, estramustine, etoposide)
- Randomized. Closed early due to thromobembolic events. 397 patients. High risk CaP (PSA 20-100 and GS >=7, or T2+, GS8, PSA <100). Neoadjuvant/concurrent and adjuvant AS + RT (2/2/2 TAA) +/- TEE Chemotherapy (taxol, estramustine, etoposide) x 4 cycles.
- 2009 PMID 18990504 -- "Phase III multi-institutional trial of adjuvant chemotherapy with paclitaxel, estramustine, and oral etoposide combined with long-term androgen suppression therapy and radiotherapy versus long-term androgen suppression plus radiotherapy alone for high-risk prostate cancer: preliminary toxicity analysis of RTOG 99-02." (Rosenthal SA, Int J Radiat Oncol Biol Phys. 2009 Mar 1;73(3):672-8. Epub 2008 Nov 5.)
  - Toxicity: AS 37% vs. AS + TEE 715 (SS), for hematological (SS), GI (SS), and trend GU (p=0.07). Three cases of MDS/AML in TEE arm
  - Conclusion: TEE associated with significantly increased toxicity during treatment

University of North Carolina - PMID 16609031 - "A phase II trial of celecoxib in prostate-specific antigen recurrent prostate cancer after definitive radiation therapy or radical prostatectomy" (Pruthi RS, Clin Cancer Res. 2006 Apr 1;12(7 Pt 1):2172-7.)
- 40 pts. Celecoxib (Celebrex) 400 mg/day. 36 of 40 (90%) had a slowing of PSA; 11 of 40 with decline in PSA, 8 with stable disease.