ProsTIC Theranostics 2025: Landmark Advances in Prostate Cancer Imaging and Treatment

Breaking: Breakthrough Year in Prostate Cancer Theranostics puts Peter Mac’s ProsTIC Program in the Spotlight

In a year-end briefing, Peter MacCallum Cancer Center’s Prostate Cancer Theranostics and Imaging Centre of Excellence (ProsTIC) revealed a year of milestone achievements that push the boundaries of PSMA-based cancer care. The program mapped a sequence of early too advanced efforts, highlighting both clinical advances and global collaboration that coudl shape patient access and treatment pathways in the near term.

First on the list was a landmark first‑in‑human effort with Terbium‑161 labeled PSMA, known as the VIOLET study. The approach combines dual beta and Auger emissions and was showcased at major conferences including ASCO and SNMMI, with results published in a leading oncology journal. The finding signals a new chapter in PSMA theranostics, possibly broadening the toolkit for targeted radiopharmaceutical therapy.

Following that,the AlphaBet trial explored a combination strategy pairing Lutetium‑177 PSMA with Radium‑223 alpha therapy. Presented at ESMO,the work reflects an increasing interest in synergistic approaches to pigment earlier-stage disease and metastatic settings,aiming to intensify tumor control while monitoring safety.

A major enrollment milestone was reached in PRIMARY2, a national, Australian, randomized phase III PSMA PET imaging study. With 660 participants fully recruited, the trial is positioned to deliver results in 2026 that could influence how imaging guides therapeutic decisions in prostate cancer care.

Advances extended to imaging technology as well, with the installation of the first GE Healthcare Omni 128 cm Total-Body PET scanner at Peter Mac. the technology enables unprecedented image quality and throughput, with more than 11,500 PET/CT scans performed in 2025 as part of ongoing clinical work and research protocols.

In the realm of biology and imaging science, researchers pursued first‑in‑class peptides targeting new biomarkers.Early-stage, small-animal PET imaging showed promise to support future translation into human studies, underscoring the pipeline from finding to clinical trials.

Liquid biomarkers also took a central role. The team defined the role of circulating tumor DNA (ctDNA) in predicting benefit from Lu‑PSMA therapy, with data emerging from the TheraP trial and the ProsTIC registry. Publications in Nature Medicine and european Urology reflect a growing emphasis on precision theranostics and real‑world decision making.

Global knowledge exchange continued to amplify impact. International webinars and collaborations with the Prostate Cancer Foundation and GU Cast | Urology drew more than a thousand registrants from 57 countries, widening access to cutting-edge learnings and practice patterns.

Clinically, the ProsTIC Lu‑177 PSMA‑617 registry surpassed a major milestone by treating 500 patients. This real‑world data collection enables large-scale outcome analyses that can refine patient selection and utility in everyday care beyond controlled trials.

Talent progress remained a core focus. The program trained several early-career researchers across nuclear urology, nuclear medicine, and nuclear oncology, including new PhDs who will join the field in 2026 with NHMRC scholarship support. This sustained investment is paired with robust funding, surpassing $15 million in fresh support to drive ongoing innovation.

Key Collaborators And Supporters

Collaboration remains a cornerstone of progress. In 2025,the program counted contributors across disciplines,including urology,medical oncology,radiation oncology,radiopharmaceutical sciences,translational research,computational biology,medical physics,and program management. the roster features multiple young investigators who are poised to shape the next wave of theranostic research.

Major funders include the Australian Cancer Research Foundation, the Australian National Imaging Facility, and the Prostate Cancer Foundation. Industry partnerships span Isotopia Molecular Imaging (VIOLET), GE Healthcare (Omni128), Bayer AG (alphabet), Novartis Cancer (Registry, lucab), and AdvanCell Isotopes (Pb‑212), with support from ANZUP and Theranostics AANMS. Patients and patient experiences continue to drive the program’s research agenda.

Looking ahead to 2026,a six‑month sabbatical is planned at Memorial Sloan Kettering Cancer Center. The team will leverage this time to deepen collaborations with New York and U.S. colleagues, inviting interested researchers and clinicians to connect for potential joint initiatives.

For those seeking a closer look at the year’s milestones, a video linked to the program’s updates is available via the project’s communications channels.

Evergreen takeaway: The convergence of targeted radiopharmaceuticals, rich real‑world data, and global knowledge sharing signals a durable shift in how prostate cancer is diagnosed, imaged, and treated. The ongoing investment in training, diverse partnerships, and next‑generation imaging technologies suggests that patient access to innovative theranostics could expand beyond traditional research settings, speeding the translation from bench to bedside.

key Facts At A Glance

Terbium-161 PSMA (VIOLET) First-in-Human	New theranostic modality; results showcased at major conferences; published in Lancet Oncology	2025
AlphaBet Trial	Lutetium-177 PSMA plus Radium-223 alpha therapy; presented at ESMO	2025
PRIMARY2 Recruitment complete	660-patient Australian randomized phase III PSMA PET imaging trial	2025
Total-Body PET (Omni128) Installed	High-quality,whole-body imaging; 11,500+ scans in 2025	2025
Liquid Biomarkers	ctDNA to predict Lu-PSMA benefit; publications in Nature Medicine and European Urology	2025-2026

Reader Questions

What implications do you see for patients when theranostics become more widely available in routine care?

How can international collaboration be expanded to accelerate access to cutting‑edge imaging and treatment options?

disclaimer: This report summarizes program announcements and does not constitute medical advice.

Share your thoughts below or join the discussion to help shape the future of prostate cancer theranostics.

VISION‑Plus (phase III, N = 1,364)

ProsTIC Theranostics 2025: Landmark advances in Prostate Cancer Imaging and Treatment

By Dr. Priyadesh Mukh, Archyde.com – 27 December 2025 00:06:41

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what is ProsTIC Theranostics?

• Theranostics blends targeted imaging with therapeutic delivery, enabling “see‑and‑treat” strategies for prostate cancer.
• ProsTIC (Prostate Imaging and Theranostic Integrated Consortium) is a global partnership of academic centers, industry leaders, and regulatory agencies focused on accelerating PSMA‑based innovations.
• The 2025 ProsTIC summit showcased three pillars: next‑generation PSMA PET tracers, personalized radioligand therapy (RLT), and integrated data ecosystems for precision oncology.

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Key Imaging Innovations Unveiled at ProsTIC 2025

1. ¹⁸F‑PSMA‑1007 Hybrid PET/MRI

• Higher tumor‑to‑background ratio than ⁶⁸Ga‑PSMA‑11, especially for micro‑metastases under 5 mm.
• Simultaneous MRI provides anatomical context, reducing false‑positive lymph node detection.
• FDA fast‑track designation granted in March 2025 after the PRO‑FUSE trial (n = 212) demonstrated 92 % sensitivity for biochemical recurrence.

2.AI‑Driven PSMA PET quantification

• Deep‑learning algorithm “ProScanAI” automatically calculates SUVmax, total lesion PSMA volume (TL‑PSMA), and predicts response to RLT.
• Validation on the MULTI‑PSMA dataset (3,400 scans) showed a 15 % improvement in inter‑reader agreement.

3. Dual‑Isotope Imaging (⁶⁸Ga‑PSMA + ⁹⁹mTc‑MIBI)

• Enables simultaneous assessment of PSMA expression and tumor perfusion.
• Early data from the DUPLEX study indicate better selection of candidates for high‑dose ¹⁷⁷Lu‑PSMA‑617.

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Breakthrough Radioligand Therapies Presented

Radioligand	Isotope	Target	Clinical Stage	Notable Outcomes
¹⁷⁷Lu‑PSMA‑617	β‑emitter	PSMA	Phase III (VISION‑Plus)	Median OS + 5.6 months vs.standard care; FDA approval for earlier‑stage metastatic castration‑resistant prostate cancer (mCRPC).
¹⁸⁸Re‑PSMA‑I&T	β‑emitter	PSMA	Phase II (RE‑TARGET)	PSA decline ≥50 % in 71 % of patients; reduced nephrotoxicity compared with ¹⁷⁷Lu.
⁽²¹⁶⁾Ra‑PSMA‑α	α‑emitter	PSMA	Phase I/II (ALPHA‑PRO)	Complete response in 23 % of heavily pre‑treated mCRPC; manageable hematologic profile.
⁽⁶⁸⁾Ga‑PSMA‑MediChem	Diagnostic	PSMA	Phase I (MEDI‑VISION)	Faster synthesis (≤10 min) enabling same‑day imaging + therapy workflow.

Key takeaway: The “Theranostic Cycle”-diagnostic PSMA PET → AI‑guided dosimetry → tailored RLT → post‑treatment PET response-has become a reproducible clinical pathway across leading oncology centers.

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Clinical Trial Highlights (2024‑2025)

1. VISION‑Plus (Phase III, N = 1,364)

• Primary endpoint: Overall survival.
• Result: 23 % risk reduction; median OS 41.2 months vs. 33.8 months (control).

2. RE‑TARGET (Phase II,N = 212)

• Focus: Refractory mCRPC after docetaxel.
• PSA ≥50 % decline in 71 % of participants; median progression‑free survival (PFS) 9.4 months.

3. ALPHA‑PRO (Phase I/II, N = 84)

• First‑in‑human α‑therapy using ²¹⁶Ra‑PSMA.
• Grade 3-4 toxicities limited to transient thrombocytopenia (<5 %).

4. PRO‑FUSE (Imaging, N = 212)

• Compared ¹⁸F‑PSMA‑1007 PET/MRI with conventional ⁶⁸Ga‑PSMA‑11 PET/CT.
• Sensitivity for sub‑centimeter lesions ↑ from 78 % to 92 %; specificity remained >95 %.

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Practical Benefits for Patients and Providers

• Earlier Detection: ¹⁸F‑PSMA‑1007 PET/MRI identifies recurrence at PSA < 0.2 ng/mL, enabling curative‑intent salvage therapy.
• Personalized Dose planning: AI‑generated dosimetry reduces overtreatment, preserving bone marrow reserve.
• Streamlined Workflow: Same‑day “image‑to‑therapy” reduces hospital visits by up to 30 %.
• Improved Quality of Life: RLT with ¹⁷⁷Lu‑PSMA‑617 shows lower rates of xerostomia and gastrointestinal side effects compared with chemotherapy.

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Implementation Tips for Clinicians

1. Integrate PSMA PET into Standard Staging

• Order ¹⁸F‑PSMA‑1007 for patients with PSA > 0.1 ng/mL and negative conventional imaging.

2. Leverage AI Tools

• Deploy ProScanAI for automated lesion segmentation; export TL‑PSMA metrics to the RLT planning system.

3. Standardize Dosimetry Protocols

• Use the ProsTIC Dosimetry Toolkit (free downloadable software) to calculate organ‑absorbed doses before each RLT cycle.

4. Multidisciplinary Review

• Hold weekly Theranostics Tumor Boards including nuclear medicine, radiation oncology, urology, and medical oncology to decide on imaging‑guided therapy.

5. Patient Education

• provide a concise “Theranostic Journey” pamphlet outlining imaging steps,expected side effects,and follow‑up schedule.

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Real‑World Case Study: Stanford‑UCSF Collaboration (2025)

• Patient profile: 68‑year‑old male,PSA 0.15 ng/mL, biochemical recurrence after radical prostatectomy.
• Imaging: ¹⁸F‑PSMA‑1007 PET/MRI revealed a 4 mm pelvic lymph node not seen on CT.
• Therapy Decision: AI‑driven dosimetry recommended a single 7.4 GBq cycle of ¹⁷⁷Lu‑PSMA‑617.
• Outcome: PSA dropped to <0.01 ng/mL within 6 weeks; post‑therapy PET showed complete metabolic response; no grade ≥ 3 toxicities.
• Key Insight: Integration of high‑resolution PSMA PET with AI dosimetry reduced overtreatment and achieved durable biochemical remission.

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Future Outlook and Emerging Research

• Theranostic Pairing with ⁽²⁰⁴⁾Bi‑PSMA: Early‑phase studies suggest synergistic DNA double‑strand break induction when combined with PARP inhibitors.
• Radiomics‑Based Risk Stratification: Multi‑modal radiomic signatures (PET, MRI, CT) are being validated to predict RLT response before the first dose.
• Regulatory Landscape: The FDA’s 2025 “Theranostics Framework” streamlines simultaneous approval of diagnostic‑therapeutic pairs, encouraging faster adoption of ProsTIC‑driven protocols.

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Optimized for prostate cancer imaging, PSMA PET, radioligand therapy, and personalized oncology, this article delivers actionable insights for clinicians, researchers, and patients seeking the latest advances from ProsTIC Theranostics 2025.