Published 25 August 2009

Systemic Program

Prostate

HRPC Pre-Chemo

1. Phase II: GW786084 +/- Casodex for HRPC (open now - VC)
2. Phase II: ZD6474 vs. Casodex in HRPC (open now - VC, CSI)

HRPC First-Line Chemo/ Docetaxel-Based

1. Phase III: Docetaxel +/- VEGF Trap (open - VC)
2. Phase I: Docetaxel + LBH first line or after prior docetaxel (open - VC)

HRPC After First-Line Chemo

1. Phase II: Panobinostat (HDAC inhibitor) after 2 lines of previous chemotherapy (open - VC, CSI)

Neoadjuvant

1. Phase II: CP-751,871 (IGF1-R monoclonal antibody) neoadjuvant prior to prostatectomy (open)
2. Phase III: NCIC.CTG.PR12 – Neoadjuvant hormone therapy +/- docetaxel prior to radiation (open)

Kidney

Adjuvant

1. Phase III Adjuvant Sunitinib/Sorefenib (open at VGH)

First Line

1. Phase III: Pazopanib vs. Sunitinib (open)

Second Line

1. CCI-779 vs. Sorafenib after Sunitinib (open) + Biomarker study (investigator initiated)

Testes

Phase II of sunitinib in chemo-resistant disease (open)

Bladder

Phase II of sunitinib for urothelial cancer (open - VC)

Radiation Oncology

1. ASCEND RT- primary therapy for intermediate, and lower tier high risk prostate cancer. All patients receive a year of androgen ablation, with eight months neoadjuvant, pelvic irradiation, randomized to dose escalation with external beam vs brachy boost. Generally meeting accrual targets
2. Prias - active surveillance low risk prostate cancer. International registration protocol for low risk prostate cancer patients managed with curative intent (i.e. not passive watchful waiting). Involves specific monitoring protocol including repeat biopsy, dre and psa follow-up
3. IMVRT - primary therapy for low risk prostate cancer. Randomized trial monotherapy with brachytherapy vs hypofractionated dose escalated prostate irradiation with IMRT
4. DART - NCIC PR 12- primary therapy for high risk prostate cancer. Randomized trial. All patients receive neoadjuvant ablation then prostate irradiation followed by adjuvant androgen ablation (total AA three years). Patients randomized to receive taxotere chemo vs no chemo during neoadjuvant therapy
5. Radicals - NCIC pr 13. MRC sponsored trial. Adjuvant and salvage therapy for prostatectomy. Factorial design with multiple randomizations. Patients at definite risk of relapse receive adjuvant RT and randomized to no androgen ablation, short AA, or long AA. Patients at an uncertain risk are randomized to same second randomization as definitive risk, vs observation. Patients at a low risk of relapse have their RT deferred and are followed and then at relapse receive salvage RT and are randomized to no androgen ablation, short AA, or long AA
6. RTOG 0526: Salvage Brachytherapy for locally recurrent prostate cancer after external beam irradiation, Phase 2 study. Eligibility: Initial Stages T1-T2c, Gleason scores 2-6, and PSA ≤ 20 ng/mL, or Stages T1-T2c, Gleason score 7, and PSA ≤ 10. No mets. IPSS < 15. PSA value < 10 ng/mL. No prior EBRT to the prostate that exceeded 72 Gy (2 Gy fractions) or equivalent
7. RTOG 0415: A phase III randomized study of hypofractionated 3D-CRT/IMRT versus conventionally fractionated 3D-CRT/IMRT in patients with favourable-risk prostate cancer. Study size: 1067. Eligibility: Histologically confirmed prostate adenocarcinoma within 180 days of randomization. Clinical stage T1-2c (AJCC 6^th edition). PSA < 10 ng/mL within 180 days prior to registration. Treatment: Arm 1 (Minimum PTV prescription) 3D-CRT or IMRT: 73.8 Gy in 41 fractions. Arm 2 (Minimum PTV prescription) 3D-CRT or IMRT: 70 Gy in 28 fractions
8. IMAX: (Phase I) IMAX study (Intraprostatic MAXimal simultaneous boost): A dose-escalation study using a maximal simultaneous intraprostatic boost with RapidArc intensity modulated radiotherapy in intermediate risk prostate cancer. Eligibility: Intermediate risk prostate cancer. No hormone therapy. This dose-escalation study will deliver 73.7 Gy in 28 #s (although this dose is specified differently, it is exactly equivalent to the 70 Gy in 28#s used without complications in IMVI-RT and as specified by RTOG 0415) to the PTV concurrent with three dose levels of simultaneous intraprostatic boost (SIB)

Access to clinical trials for patients with GU cancer are also available at other programs, in particular at the Prostate Centre. Trials open at the Prostate Centre.