Active trials


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BCG+MMC
BL 12
ENZAMET
ENZARAD
KEYPAD
P3BEP
Pain-Free TRUS B
TheraP

BCG+MMC

Adding mitomycin C to BCG ad adjuvant intravesical therapy for high-risk, non-muscle-invasive bladder cancer: a randomised phase 3 trial

Trial Summary:

To determine the efficacy and safety of MMC in addtion to BCG in patients with non-muscle, invasive bladder cancer

Supported By: Cancer Australia
Eligibility:Adults with resected, high-risk non-muscle, invasive bladder cancer (high grade Ta or any grade T1) suitable for intravesical chemotherapy treatment
Registration ID:ACTRN12613000513718
Participation:Australia
Australian Lead Group:ANZUP
Status:Open
Activation Date:First Site Activated 2-Dec-2013
Chairs:Dickon Hayne
Contact:bcgmmc@ctc.usyd.edu.au

BL 12

A multicentre randomised phase II trial comparing nab-paclitaxel to paclitaxel in patients with advanced urothelial cancer progressing on or after a platinum containing regimen

Trial Summary:

This is a CCTG led phase II, multicentre, open-label study  to assess whether there is a difference in progression free survival between patients receiving paclitaxel and those receiving nab-paclitaxel.

Supported By: STA; NHMRC CTC
Eligibility:Patients with advanced urothelial cancer who have progressed on or after a platinum containing regimen
Registration ID: ACTRN12614001079639
Participation:International
Australian Lead Group:ANZUP
Status:Closed
Activation Date:17/04/2015
Chairs:Ben Tran
Contact:bl12@ctc.usyd.edu.au

ENZAMET

Randomised phase 3 trial of enzalutamide in first line androgen deprivation therapy for metastatic prostate cancer

Trial Summary:

To determine the effectiveness of enzalutamide versus a conventional NSAA, when combined with a lutenising hormone releasing hormone analogue (LHRHA) or surgical castration, as first line androgen deprivation therapy.

Supported By: Astellas Scientific and Medical Affairs Inc.
Eligibility:Men (≥ 18 years) with metastatic prostate cancer commencing androgen deprivation therapy.
Registration ID:ACTRN12614000110684
Participation:International
Australian Lead Group:ANZUP
Status:Follow-Up
Activation Date:First Site Activated 28-Mar-14
Chairs:Ian Davis and Christopher Sweeney
Contact:ENZAMET@ctc.usyd.edu.au

ENZARAD

Randomised phase 3 trial of enzalutamide in androgen deprivation therapy with radiation therapy for high risk, clinically localised, prostrate cancer

Trial Summary:

To determine the effectiveness of enzalutamide as part of adjuvant androgen deprivation therapy with a lutenising hormone releasing hormone analogue (LHRHA) in men having radiotherapy for localised prostate cancer at high risk of recurrence.

Supported By: Astellas Scientific and Medical Affairs Inc.
Eligibility:Men (≥ 18 years) with localised prostate cancer at high risk for recurrence deemed suitable for external beam radiation therapy
Registration ID:ACTRN12614000126617
Participation:International
Australian Lead Group:ANZUP
Status:Open
Activation Date:First Site Activated 28-Mar-14
Chairs:Scott Williams and Paul Nguyen
Contact:ENZARAD@ctc.usyd.edu.au

KEYPAD

Denosumab and Pembrolizumab in clear cell renal carcinoma: a phase II trial

Trial Summary:

Single-arm, multicentre, phase 2 trial to determine the activity and safety of pembrolizumab and denosumab in advanced clear cell renal cell carcinoma (ccRCC).

Supported By: AMGEN and MSD
Eligibility:Adults with unresectable or metastatic ccRCC progressing after treatment with a VEGFR TKI.
Registration ID:NCT03280667
Participation:International
Australian Lead Group:ANZUP
Status:Open
Activation Date:11/12/2017
Chairs:Craig Gedye
Contact:keypad@ctc.usyd.edu.au

P3BEP

A randomised phase 3 trial of accelerated versus standard BEP chemotherapy for patients with intermediate and poor-risk metastatic germ cell tumours

Trial Summary:

To determine if accelerated BEP (Bleomycin, Etoposide and Cisplatin) is superior to standard BEP as first-line chemotherapy for intermediate and poor-risk metastatic germ cell tumours.

Supported By: Cancer Australia
Eligibility:Men ≤ 16 years but 45 years ≥ with metastatic germ cell tumours (non-seminoma and seminoma) or intermediate or poor prognostic category with adequate bone marrow, hepatic and renal function
Registration ID:ANZCTR12613000496718
Participation:Australia
Australian Lead Group:ANZUP
Status:Open
Activation Date:First Site Activated 19-Feb-14
Chairs:Peter Grimison
Contact:p3bep@ctc.usyd.edu.au

Pain-Free TRUS B

A phase 3 double-blind placebo-controlled randomized trial of methoxyflurane with periprostatic local anaesthesia (PILA) to reduce the discomfort of transrectal ultrasound-guided prostate biopsy

Trial Summary:

This study aims to determine whether the addition of inhaled methoxyflurane to PILA improves the pain, discomfort and experience of TRUS biopsy, thereby increasing men's willingness to undergo repeat TRUS prostate biopsy.

Supported By: Cancer Australia; Prostate Cancer Foundation Australia (PCFA); Medical Developments International (MDI)
Eligibility:The target population for this study is men (18 years and over) scheduled to undergo their first TRUS biopsy of the prostate for a raised PSA or abnormal digital rectal examination (DRE).
Registration ID:ACTRN12615001105538 and NCT02604225
Participation:Australia and New Zealand
Australian Lead Group:ANZUP
Status:Recruiting
Activation Date:First Site Activated 17-Dec-2015
Chairs:Jeremy Grummet
Contact:trusb@ctc.usyd.edu.au

TheraP

A randomised phase 2 trial of 177Lu-PSMA617 theranostic versus cabazitaxel in progressive metastatic castration resistant prostate cancer (ANZUP1603)

Trial Summary:

To determine the activity and safety of Lu-PSMA vs cabazitaxel in patients with castration resistant prostate cancer.

Supported By: Prostate Cancer Foundation Australia (PCFA), Endocyte, Australian Nuclear Science and Technology Organisation (ANSTO)
Eligibility:Men with castration resistant prostate cancer suitable for chemotherapy with cabazitaxel (surgical or medical castration, and previous chemotherapy with docetaxel).
Registration ID:ACTRN12617001590358
Participation:Australia
Australian Lead Group:ANZUP
Status:Recruiting
Activation Date:29th January 2018
Chairs:A/Prof Michael Hofman
Contact:therap@ctc.usyd.edu.au