Innovative Research
Welcome the research lab of Dr. Fred Saad
At the forefront of innovation in uro-oncology, Dr. Fred Saad leads a world-renowned research program dedicated to transforming the treatment landscape for genitourinary cancers. As Full Professor and Head of the Department of Urology, as well as Director of Urological Oncology at the University of Montreal Hospital Center (CHUM), Dr. Saad merges clinical excellence with cutting-edge molecular research to develop novel therapeutic strategies and identify prognostic tools. He also serves as Director of the Molecular Oncology Laboratory for Prostate Cancer at the Montreal Cancer Institute, while overseeing oncology research at the CHUM Research Center, where he drives forward multidisciplinary efforts to improve patient outcomes.
Our research team focuses on:
- Molecular oncology and the mechanisms driving cancer progression
- Development of novel therapeutics for advanced prostate cancer
- Identification of prognostic biomarkers to personalize treatment
- Collaborative clinical trials that shape global standards of care.
Developing Scientific Initiatives
SatisfACtion: Phase I/II, Open-label, Multi-center Study of [225Ac]Ac-PSMA-R2 in Men With mHSPC and Heavily Pre-treated PSMA-positive mCRPC, With/Without Prior 177Lu-labelled PSMA-targeted Radioligand Therapy
Study Objective:
This Phase I/II open-label, multi-center trial aims to evaluate the safety, tolerability, and anti-tumor activity of [225Ac]Ac-PSMA-R2—a targeted radioligand therapy—in adult men with PSMA-positive metastatic prostate cancer. The study includes patients with both metastatic hormone-sensitive prostate cancer (mHSPC) and metastatic castration-resistant prostate cancer (mCRPC), with or without prior treatment using 177Lu-PSMA therapy.
Implications for Patient Care:
The SatisfACtion trial evaluates [²²⁵Ac]Ac-PSMA-R2, a targeted alpha radioligand therapy, in patients with mHSPC and heavily pre-treated mCRPC. Its design addresses therapeutic resistance and prior exposure to β-emitting PSMA agents, aiming to enhance tumor control through highlinear energy transfer. Positive outcomes could establish a new therapeutic paradigm for PSMApositive prostate cancer.
A Phase 3, Randomized, Double Blind, Placebo Controlled Study of PF-06821497 (mevrometostat) with Enzalutamide in Metastatic Castration Resistant Prostate Cancer (MEVPRO-2)
Study Objective:
The MEVPRO-2 study aims to determine whether combining the investigational drug mevrometostat (PF-06821497) with enzalutamide improves outcomes for men with metastatic castration-resistant prostate cancer (mCRPC) compared to enzalutamide alone. The trial evaluates whether this combination can better delay disease progression in patients who have not previously received advanced hormone therapies.
Implications for Patient Care:
This Phase I/II open-label, multi-center trial aims to evaluate the safety, tolerability, and anti-tumor activity of [225Ac]Ac-PSMA-R2—a targeted radioligand therapy—in adult men with PSMA-positive metastatic prostate cancer. The study includes patients with both metastatic hormone-sensitive prostate cancer (mHSPC) and metastatic castration-resistant prostate cancer (mCRPC), with or without prior treatment using 177Lu-PSMA therapy.
A Phase 3, Randomized, Open-Label Study Of Pf-06821497 (Mevrometostat)In Combination With Enzalutamide Compared With Enzalutamide OrDocetaxel In Participants With Metastatic Castration Resistant ProstateCancer Previously Treated With Abiraterone Acetate (MEVPRO-1)
Study Objective:
The MEVPRO-1 study investigates the efficacy of mevrometostat (PF-06821497), an oral inhibitor of
EZH2, in combination with enzalutamide, in patients with metastatic castration-resistant prostatecancer (mCRPC) who have progressed following abiraterone acetate treatment. The trial comparesthis combination to either enzalutamide alone or docetaxel chemotherapy, assessing its impact onradiographic progression-free survival.
Implications for Patient Care:
The study explores whether blocking EZH2, a gene involved in turning off other genes, can affecthow advanced prostate cancer grows and responds to treatment. By combining an EZH2inhibitor with hormone-targeting therapy, researchers aim to understand how changes in generegulation may help control metastatic castration-resistant prostate cancer and guide futuretreatment strategies.
MK-5684-01A Substudy: A Phase 1/2 Umbrella Substudy of MK-5684-U01Master Protocol to Evaluate the Safety and Efficacy of MK-5684-basedTreatment Combinations or MK-5684 Alone in Participants With MetastaticCastration-resistant Prostate Cancer (mCRPC)
Study Objective:
MK-5684-01A substudy aims to evaluate the safety, tolerability, and preliminary efficacy of
opevesostat (MK-5684), a CYP11A1 inhibitor, administered alone or in combination with otheragents in patients with metastatic castration-resistant prostate cancer (mCRPC). The studyincludes a safety lead-in phase to determine the recommended Phase 2 dose (RP2D), followed byan efficacy phase assessing prostate-specific antigen (PSA) response and objective tumor responseusing standardized criteria.
Implications for Patient Care:
This study investigates a novel therapeutic approach targeting steroid biosynthesis, which maysuppress androgen receptor signaling, a key driver of resistance in mCRPC. By exploringcombinations of Opevesostat with established treatments, the trial seeks to identify regimensthat could overcome resistance mechanisms and improve clinical outcomes for individuals withadvanced prostate cancer.
MK-5684-004: A Phase 3, Randomized, Open-label Study of OpevesostatVersus Alternative Abiraterone Acetate or Enzalutamide in ParticipantsWith Metastatic Castration-resistant Prostate Cancer (mCRPC) ThatProgressed On or After Prior Treatment With One Next-generationHormonal Agent (NHA) (OMAHA-004)
Study Objective:
This Phase 3 study evaluates the efficacy and safety of opevesostat (MK-5684), a CYP11A1 inhibitor,
combined with hormone replacement therapy (HRT), compared to alternative next-generationhormonal agents—abiraterone acetate or enzalutamide—in patients with metastatic castration-resistant prostate cancer (mCRPC) who have progressed after one prior hormonal therapy. Theprimary endpoints include radiographic progression-free survival and overall survival, assessed inboth androgen receptor ligand-binding domain mutation-positive and -negative populations.
Implications for Patient Care:
By targeting steroid biosynthesis upstream of androgen receptor activation, opevesostat mayoffer a novel mechanism to delay disease progression in mCRPC. This trial could help define anew therapeutic strategy for patients who have limited options after resistance to first-linehormonal agents, potentially improving long-term disease control and survival outcomes.
A Phase 1 Open-label, First-in-human, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of Actinium-225-macropa-pelgifatamab (BAY 3546828) in Participants With Advanced Metastatic Castration Resistant Prostate Cancer (mCRPC)
Study Objective:
This Phase 1, first-in-human study investigates the safety, tolerability, pharmacokinetics, and
preliminary antitumor activity of actinium-225-macropa-pelgifatamab (BAY3546828) in individuals with advanced metastatic castration-resistant prostate cancer (mCRPC). The radioligand therapy targets prostate-specific membrane antigen (PSMA) and delivers alpha radiation directly to cancer cells. The trial aims to identify an optimal dose that balances safety with therapeutic efficacy.
Implications for Patient Care:
By selectively targeting PSMA-expressing tumor cells with localized alpha radiation, BAY3546828represents a novel therapeutic strategy for mCRPC. This approach may offer enhanced tumor control with reduced systemic toxicity, potentially addressing treatment resistance and improving clinical outcomes in a population with limited therapeutic options.
A Phase 1/2 Study of EG-70 as an Intravesical Administration to Patients With BCG-Unresponsive Non–Muscle Invasive Bladder Cancer (NMIBC) and High-Risk NMIBC Patients Who Are BCG-Naïve or Received Incomplete BCG Treatment
Study Objective:
This Phase 1/2 study evaluates the safety, tolerability, and preliminary efficacy of EG-70, a novel non-viral gene therapy, administered intravesically in patients with non-muscle invasive bladder cancer (NMIBC) who are unresponsive to Bacillus Calmette-Guérin (BCG) or have received incomplete BCG treatment. The study includes a dose-escalation phase to determine the recommended Phase 2 dose, followed by an efficacy phase assessing tumor response and durability of effect.
Implications for Patient Care:
EG-70 is designed to stimulate a localized immune response within the bladder urothelium,aiming to eliminate cancer cells while minimizing systemic toxicity. This approach may offer a bladder-sparing alternative for high-risk NMIBC patients who have limited options after BCG failure, potentially improving disease control and reducing the need for radical interventions.