INTERMEDIATE RISK:
Randomized phase II feasibility trial of image guided external beam radiotherapy with or without high dose rate brachytherapy boost in men with intermediate-risk prostate cancer.
Trial ID: NCIC PR15
Coordination: NCIC
Trial Design: A phase II comparison of image guided external beam radiotherapy with or without high dose rate brachytherapy boost in men with intermediate-risk prostate cancer.
Patient Population: Men with intermediate risk prostate cancer who are able to have brachytherapy.
Sample size & primary endpoint: n=60, feasibility to accrue target over an 18 month period
HIGH RISK:
A RANDOMIZED PHASE III STUDY OF NEO-ADJUVANT DOCETAXEL AND ANDROGEN DEPRIVATION PRIOR TO RADICAL PROSTATECTOMY VS. IMMEDIATE RADICAL PROSTATECTOMY IN PATIENTS WITH HIGH-RISK, CLINCALLY LOCALIZED CaP.
Trial ID: NCIC PRC3
Coordination: Intergroup (CALG B)
Trial Design: A phase III comparison of neoadjuvant chemohomonal therapy with goserlin or leuprolide for 18-24 weeks with docetaxel IV every 3 weeks for up to 6 courses followed by RP with staging pelvic lymphadenectomy vs. RP with staging lymphadenectomy alone.
Patient Population: Men who have undergone RP within 3 months, post-operative PSA < 0.4 ng/ml. Uncertainty in the opinion of the physician and patient regarding the need for immediate post-operative XRT.
Sample size & primary endpoint: n=750, 3-year biochemical progression-free survival
POST-RADICAL PROSTATECTOMY:
RADICALS: RADIOTHERAPY AND ANDROGREN DEPRIVATION IN COMBINATION AFTER LOCAL SURGERY.
Trial ID: NCIC PR13
Coordination: Intergroup (MRC)
Trial Design: Phase III clinical trial with randomizations both for radiotherapy timing and for hormone treatment duration.
Patient Population: Men who have undergone RP within 3 months, post-operative PSA less than 0.4 ng/ml.
Sample size & primary endpoint: n=5100, disease-free survival
CASTRATE RESISTANT METASTATIC PROSTATE CANCER.
1 A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC-V/F +/- GM-CSF in Men With Asymptomatic or Minimally Symptomatic Metastatic Castrate-Resistant Prostate Cancer (Prospect)
Trial ID: NCT01322490
Coordination: CUOG
Trial Design: The purpose of this study is to determine whether PROSTVAC alone or in combination with GM-CSF is effective in prolonging overall survival in men with few or no symptoms from metastatic, castrate-resistant prostate cancer.
Patient Population: Metastatic, castrate-resistant prostate cancer.
Primary Endpoint: Overall survival
2 A PHASE II STUDY OF PX-866 IN PATIENTS WITH RECURRENT OR METASTATIC CRPC.
Trial ID: IND.205
Coordination: NCIC CTG
Trial Design: A phase II trial of the oral PI-3K inhibitor, PX-866, in men with metastatic CRPC and no prior chemotherapy.
Sample size & primary endpoint: n=40, lack of progression at 12 weeks.
3 AFFINITY: A Randomized Phase 3 Study Comparing Cabazitaxel/Prednisone in Combination with Custirsen (OGX-011-12) to Cabazitaxel/Prednisone for Second-Line Chemotherapy in Men with Metastatic Castrate Resistant Prostate Cancer.
Coordination: CUOG
This is a randomized phase 3 study comparing cabazitaxel/prednisone in combination with custirsen (OGX-011) to cabazitaxel/prednisone for treatment of men with metastatic castrate resistant prostate cancer (CRPC) who have previously received a docetaxel-containing regimen.
Phase II studies have revealed that patients who received custirsen with first-line docetaxel/prednisone treatment had overall longer survival, compared to patients who received first-line docetaxel/prednisone treatment alone. Interesting survival estimates were also observed when custirsen was added in the second line setting to docetaxel retreatment or mitoxantrone. Given the demonstrated survival benefit observed using a taxane as either first-line or second-line chemotherapy, combination with custirsen may enhance the survival benefit of taxane therapies. Specifically, the TROPIC trial demonstrated that patients who received cabazitaxel/prednisone and improved survival estimates, compared to patients who received mitoxantrone/prednisone.
The purpose of this Phase III study is to ascertain if treatment with cabazitaxel/prednisone in combination with custirsen is better than cabazitaxel/prednisone alone at increasing survival in men with CRPC. Participants will continue treatment until completion of 10 cycles, disease progression, unacceptable toxicity, or until other withdrawal criteria are met. Patients will be followed until death. Eligibility criteria are similar to the TROPIC trial in that patients have to have received and progressed on or after docetaxel therapy, and may have received up to one further cytotoxic chemotherapy regimen. However, patients who have received abiraterone and/or enzalutamide (MDV3100) and/or similar investigational agents are also eligible for AFFINITY. The total sample size is 630 patients and will be conducted in North America and Europe. Canada has been alloted eight centres.