Prostate cancer is a major global health issue, ranking as the second most common cancer in men and the fourth most common cancer overall. With its increasing incidence and significant impact on public health, prostate cancer clinical trials play a pivotal role in advancing treatment options and improving patient outcomes. This blog explores the latest insights on prostate cancer clinical trials, prevalence, treatment options, emerging therapies in clinical trials, and Lambda’s expertise in conducting prostate cancer clinical trials.

Lambda’s Oncology Expertise: A Proven Track Record

At Lambda & Novum, our commitment to advancing cancer treatment is reflected in our extensive experience in oncology clinical trials. With a strong portfolio that includes over 265 clinical trials spanning 15+ therapeutic areas, oncology remains a cornerstone of our expertise.

We have supported over 65 clinical trials, specifically targeting various cancer indications including Prostate Cancer. Our end-to-end capabilities—ranging from medical imaging to pharmacovigilance, biostatistics, and bioanalytical services—enable us to deliver comprehensive solutions for our clients. Our successful regulatory submissions to the USFDA, EMA, and ANVISA underscore our deep understanding of global regulatory frameworks and our proficiency in navigating the complexities of the approval process.

Prostate Cancer Prevalence

Current Treatments for Prostate Cancer

Treatment options for prostate cancer have significantly evolved. These include –

Chemotherapy:

• Docetaxel
• Cabazitaxel
• Mitoxantrone
• Estramustine

Immunotherapy:

• Sipuleucel-T: A cancer vaccine that stimulates the immune system to target prostate cancer cells.
• Checkpoint Inhibitors: Drugs like Pembrolizumab and Dostarlimab block proteins that suppress the immune response against cancer.

Hormone Therapy:

• LHRH Agonists: Medications like Leuprolide, Triptorelin, and Goserelin reduce testosterone production.
• LHRH Antagonists: Drugs like Degarelix and Relugolix.
• Anti-Androgens: Drugs like Bicalutamide, Flutamide, and Nilutamide inhibit the action of testosterone on cancer cells.
• Androgen Synthesis Inhibitors: Abiraterone and Ketoconazole reduce testosterone production.

Targeted Therapy:

• PARP Inhibitors: Drugs like Olaparib, Rucaparib, and Talazoparib are used for patients with specific genetic mutations to target cancer cells more precisely.

Radiation Therapy:

• External Beam Radiation Therapy (EBRT): High-energy rays are directed at the prostate to kill cancer cells.
• Brachytherapy: Radioactive seeds are implanted directly into the prostate gland.

Surgery:

• Radical Prostatectomy: A procedure to remove the entire prostate gland, typically recommended for localized prostate cancer.

Radiopharmaceuticals:

• Radium-223 Dichloride and Lutetium Lu 177 are used to treat advanced prostate cancer, particularly when it has spread to the bones.

Current pipeline for Prostate Cancer

The current research pipeline for prostate cancer is rich with promising therapies. Some of the leading therapies in development include:

Drug	Company	Phase	Mechanism of Action	Route of Administration
Pembrolizumab	Merck & Co	Phase-III	Programmed cell death-1 receptor antagonists	Intravenous
Talazoparib	Pfizer	Phase-III	Poly(ADP-ribose) polymerase inhibitors	Oral
Capivasertib	AstraZeneca	Phase-III	Proto oncogene protein c-akt inhibitors	Oral
VERU-111	Veru Healthcare	Phase-III	Tubulin inhibitors; Tubulin polymerisation inhibitors	Oral
MBM-02	Matrix Biomed	Phase-II	Antioxidants; Blood coagulation factor inhibitors; Inflammation mediator inhibitors; RNA replicase inhibitors	Oral
ZEN 3694	Zenith Epigenetics	Phase-II	Bromodomain and extraterminal domain protein inhibitors	Oral
Onilcamotide	RhoVac	Phase-II	Immunostimulants	Subcutaneous
IMMU-132	Gilead Sciences	Phase-II	DNA topoisomerase I inhibitors	Intravenous
PT-112	Promontory Therapeutics	Phase-II	Apoprotein stimulants; Apoptosis stimulants	Intravenous
EPI-7386	ESSA Pharma	Phase-I/II	Androgen receptor antagonists
REGN4336	Regeneron Pharmaceuticals	Phase-I/II	Antibody-dependent cell cytotoxicity	Subcutaneous
HB-302	Hookipa Biotech	Phase-I/II	Immunomodulators	Intravenous
BNT112	BioNTech SE	Phase-I/II	NA	Intravenous
AMG 509	Amgen	Phase-I	Antibody-dependent cell cytotoxicity; T lymphocyte stimulants	Intravenous
JANX007	Janux Therapeutics	Phase-I	Immunologic cytotoxicity; T lymphocyte stimulants	Intravenous
ORIC-944	ORIC Pharmaceuticals	Phase-I	Polycomb repressive complex 2 inhibitors	Oral

Metastatic Prostate Cancer Recent Developments

• November 2024: AstraZeneca’s Truqap (capivasertib) combination in PTEN-deficient metastatic hormone-sensitive prostate cancer demonstrated statistically significant and clinically meaningful improvement in radiographic progression-free survival in CAPItello-281 Phase III trial.
• In September 2024, Ipsen announced that the Phase III CONTACT-02 trial for Cabometyx® and atezolizumab in mCRPC showed a non-significant improvement in overall survival but met the progression-free survival (PFS) endpoint.
• In September 2024, Foundation Medicine received FDA approval for FoundationOne®CDx and Liquid CDx as companion diagnostics for Lynparza® in BRCA-mutated mCRPC.
• In July 2024, the ARANOTE trial showed that NUBEQA® plus ADT significantly improved radiological PFS in metastatic hormone-sensitive castrate-resistant prostate cancer (mHSPC).
• In July 2024, the FDA granted fast-track designation to SYNC-T SV-102 for metastatic castrate-resistant prostate cancer (mCRPC).
• In June 2024, Kangpu Biopharmaceuticals received FDA approval for a Phase II/III trial of KPG-121 with Abiraterone for mCRPC.
• In May 2024, Fusion Pharmaceuticals began the Phase 2 AlphaBreak trial of FPI-2265 in mCRPC patients.
• In April 2024, Astellas Pharma received European approval for XTANDI™ in high-risk biochemical recurrent non-metastatic hormone-sensitive prostate cancer (nmHSPC).
• In April 2024, FibroGen announced positive Phase 1 trial data for FG-3246 in mCRPC.
• On November 16, 2023, the FDA approved enzalutamide (Xtandi) for non-metastatic castration-sensitive prostate cancer (nmCSPC) with high-risk biochemical recurrence.

Lambda experience in Prostate Cancer Clinical Trials

Lambda Therapeutic Research has extensive experience in conducting prostate cancer clinical trials, including comprehensive regulatory support for global submissions, adhering to the standards set by key health authorities such as ANVISA (Brazil), USFDA (United States), and DCGI (India). Some of our studies include:

• Docetaxel Lipid Suspension (NDLS) for Metastatic Castration-Resistant Prostate Cancer (Phase II, 75 patients, 25 sites).
• Goserelin Acetate Implant for advanced prostate cancer (Phase III, 94 patients, 20 sites).
• Cabazitaxel for Metastatic Castration-Resistant Prostate Cancer (Phase II, 75 patients, 25 sites).

Product	Number of Clinical Studies
Abiraterone Acetate	4
Apalutamide	4
Bicalutamide	2
Cabazitaxel	1
Docetaxel	3
Enzalutamide	21
Olaparib	2
Relugolix	2

Optimizing Prostate Cancer Clinical Trials

Strategic Site Selection

Selecting the right sites is the backbone of successful prostate cancer clinical trials. We focus on partnering with experienced investigators and site teams who specialize in clinical oncology and understand the nuances of prostate cancer management. This careful selection ensures accurate data collection and a more seamless, supportive experience for patients.

Streamlining Recruitment & Retention

Patient participation is at the heart of every successful trial. To overcome common barriers, we implement patient-first initiatives and engage dedicated care coordinators who offer personalized support throughout the trial journey. By building trust and reducing obstacles, we not only enhance recruitment and retention but also improve patient outcomes and ensure better data collection.

Innovative Trial Protocols

Innovation drives everything we do. Our trial protocols are thoughtfully designed to be patient-centric and practical, incorporating the latest advancements to meet the unique needs of prostate cancer patients. By prioritizing patient comfort and operational efficiency, we create a smoother trial experience that leads to better outcomes and seamless data collection.

Transform Your Oncology Trials with Our Proven Expertise

Explore Our Success Stories:

Leverage Lambda & Novum’s extensive experience & proven track record to accelerate your Oncology clinical trials. Get in touch with our team of experts.

About Lambda

Lambda & Novum delivers full-service CRO services to the innovator, biotech, and generic pharmaceutical industries worldwide. With a strong global presence in India, the USA, Canada, the UK, Barcelona (Spain) and Poland, we bring specialized expertise to every project. Our focus on secure IT infrastructure and automation ensures timely project delivery and strict adherence to international regulatory standards. Lambda’s exemplary regulatory track record includes over 60 successful inspections and audits by esteemed authorities, including the USFDA, EMEA, MHRA, EU member states, and other global regulatory bodies, in the past five years.

Lambda’s commitment to excellence has garnered significant recognition, including the ‘Best Indian CRO’ award from Frost & Sullivan (USA) and the ‘Great Indian Workplace’ title from UBS Transformance. Recent accolades include the ‘Regulatory Excellence’ Award at the CPhI Pharma Awards 2023 and the ‘Industry Partner of the Year’ Award at the Global Generics & Biosimilar Awards 2023.

References:

• https://www.cancer.org/cancer/prostate-cancer/about/key-statistics.html
• https://www.cancer.gov/types/prostate/patient/prostate-treatment-pdq
• https://www.mayoclinic.org/diseases-conditions/prostate-cancer/symptoms-causes/syc-20353098
• https://www.who.int/news-room/fact-sheets/detail/prostate-cancer
• https://www.delveinsight.com/report-store/metastatic-prostate-cancer-pipeline-insight