ProsTIC clinical trials

LuCAB is a prospective, single-centre, single-arm, phase I/II trial recruiting 38 men over 18 months (about one and a half years) to establish the maximum tolerated dose (MTD), dose-limiting toxicities (DLTs), and recommended phase 2 dose (RP2D) of cabazitaxel in combination with 177Lu-PSMA-617 in patients with metastatic castration-resistant prostate cancer (mCRPC). This study is now open for recruitment. More information. ASCO GU Poster.

This is a prospective multicentred, randomized, phase III trial which will evaluate the addition of PSMA PET as non‐inferior to standard of care (SOC) & to detect clinically significant prostate cancer (sPCa) while providing the advantages of (1) reducing unnecessary biopsies and (2) limiting to targeted‐only biopsies in men with clinical risk of prostate cancer (PCa) and negative or equivocal MRI. 660 men will be enrolled in this trial (330 in experimental arm, 330 in control arm) from 5+ sites over a recruiting period of three years with a potential two-year follow-up for participants. This study is currently open for recruitment.  More information. ASCO GU Poster.

This phase 1 study examines the use of Lu-PSMA in combination with a PARP inhibitor (olaparib) in men with castration-resistant metastatic prostate cancer who have progressed on prior novel androgen-receptor targeted agents (enzalutamide, abiraterone and/or apalutamide). Radiation therapy kills cancer cells by damaging DNA. PARP-inhibitors are therapies that kill cancer cells by preventing their ability to repair damaged DNA. In this study we will examine whether PARP-inhibitors may synergize with radiation therapy in killing cancer cells by preventing DNA repair after radiation-induced DNA damage. This study is currently open for recruitment.  More information

POPSTAR II will be investigating focal targeted radiotherapy alone or combined with 2 cycles of targeted radionuclide therapy in men with limited sites of metastatic prostate cancer. This is an open label, randomised, non-comparative, stratified phase II clinical trial recruiting 92 patients. Patients with oligometastatic prostate cancer will be randomised in a 1:1 ratio to either stereotactic ablative body radiotherapy (SABR) alone or SABR plus 2 cycles of Lu-PSMA. This study is currently open for recruitment. More information.

AlphaBet will be recruiting 36 men with Metastatic Castration-Resistant Prostate Cancer over 24 months (about two years) for a prospective, single-centre, single-arm phase I/II trial. The study aims to establish the maximum tolerated dose (MTD), dose-limiting toxicities (DLTs), and recommended phase 2 dose (RP2D) of Radium-223 (223Ra) in combination with lutetium-177-prostate-specific membrane antigen-Imaging & Therapy (177Lu-PSMA-I&T) in patients with metastatic castration-resistant prostate cancer (mCRPC). In phase II, AlphaBet aims to find out treatment efficacy (Prostate-Specific Antigen-Response Rate [PSA-RR]). This study is currently open for recruitment. More information. ASCO GU Poster.

VIOLET is recruiting 30 men for a prospective, single-centre, single-arm phase I/II trial. 

Phase I aims to establish the maximum tolerated dose (MTD), dose-limiting toxicities (DLTs), and recommended phase 2 dose (RP2D) of [161Tb]Tb -PSMA-I&T in patients with metastatic castration-resistant prostate cancer (mCRPC). 

Phase II aims to evaluate the safety of [161Tb]Tb -PSMA-I&T in patients with mCRPC. 

This study is now fully recruited. More information. ASCO GU Poster. JNM publication.

This phase 2 randomised study for men with newly diagnosed metastatic prostate cancer recruited at 11 Australian studies. Men must have “high volume” disease defined on a PSMA PET/CT scan. Men will be randomised to the experimental arm (Lu-PSMA followed by docetaxel chemotherapy) or standard-of-care (docetaxel). All men with receive androgen deprivation therapy (ADT). This study is now closed for recruitment. More information. The Lancet publication.

In this study, 20 men with newly diagnosed prostate cancer and high-risk features scheduled to undergo prostatectomy with have 1 or 2 cycles of Lu-PSMA prior to surgery. After each cycle of Lu-PSMA, imaging will be performed to assess how much radiation was delivered to prostate cancer. We will also assess the biochemical, imaging and pathology response to Lu-PSMA. This study is now closed for recruitment. More information. European Urology publication.

This is an open label, randomised, stratified, 2-arm, multicentre phase 2 clinical trial recruiting 160 participants over 12 months and followed until 150 events occurred (approximately another 18 months). Participants will be randomised to enzalutamide or enzalutamide and Lu-PSMA in a 1:1 ratio. A minimisation approach will be used to minimise chance imbalances across the following stratification factors: study site, volume of disease (>20 versus ≤20 sites of disease measured on 68Ga-PSMA PET/CT), prior treatment with early docetaxel for castration- sensitive disease (yes vs no), and prior treatment with early abiraterone for castration-sensitive disease (yes vs no).

This is an open label, randomised, stratified, 2-arm, multicentre phase 2 clinical trial (led by ANZUP, the Australian and New Zealand Urogenital and Prostate Cancer Trials Group) recruiting 160 participants over 12 months and followed until 150 events occurred (approximately another 18 months). This study is now closed for recruitment. More information. BJU International publication. 

This phase II study is to investigate the activity and safety of radionuclide 177Lu-PSMA therapy versus 177Lu-PSMA in combination with Ipilimumab and Nivolumab in patients with metastatic castrate resistant prostate cancer (mCRPC). This is an open label, randomised, stratified, multicentre phase 2 clinical trial recruiting 110 participants over 18 months (about one and a half years) and followed for 12 months.This study is now closed for recruitment. . More Information

This trial examines the use of Lu-PSMA in combination with immunotherapy (pembrolizumab) in men with castration-resistant metastatic prostate cancer who have progressed on prior enzalutamide, abiraterone and/or apalutamide. If suitable, men in this trial will be treated with up to 6 cycles of Lu-PSMA and pembrolizumab for up to 35 cycles. This study is now closed for recruitment. More information