What to Expect and Plan for in Pluvicto Treatment:
What to Expect and Plan for in Pluvicto Treatment: A Comprehensive Guide for Prostate Cancer Patients
Special Report for the IPCSG Newsletter
Major FDA Expansion Opens Treatment to More Patients
On March 28, 2025, the FDA expanded approval for Pluvicto (lutetium Lu 177 vipivotide tetraxetan) to include patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor pathway inhibitor (ARPI) therapy and are considered appropriate to delay chemotherapy. This expanded indication approximately triples the number of patients eligible to receive Pluvicto.
This groundbreaking development means that many more patients can now access this innovative treatment earlier in their disease progression, potentially before requiring chemotherapy.
Understanding Pluvicto: How It Works
Pluvicto is a "theranostic" medicine that combines diagnostic and therapeutic capabilities. It's a type of radiation that specifically targets a molecule on the surface of prostate cancer cells called PSMA (prostate-specific membrane antigen). The medication attaches to the PSMA protein like a key going into a lock. Once attached, it delivers radiation to the cell that damages the cell DNA and causes the cell to die.
About 80% of prostate cancer patients have PSMA-positive tumors; for those who do not, the treatment is ineffective. Before treatment, patients must undergo a PSMA PET scan using the companion diagnostic Locametz to confirm eligibility.
Treatment Protocol: What to Expect
The Treatment Schedule
Pluvicto treatment consists of 6 separate infusions given every 6-10 weeks, spanning approximately 8 months total. The recommended dose is 7.4 GBq (200 mCi) intravenously every 6 weeks for up to 6 doses, or until disease progression or unacceptable toxicity.
Pre-Treatment Requirements
- Lab work must be completed 5-7 days prior to each infusion - this can be done at UCSD lab or an outside lab
- Laboratory tests within 3 days before your first treatment will be performed to check blood counts and kidney function
- PSMA PET scan to confirm eligibility - shows if prostate cancer cells express PSMA
During Each Infusion Visit at UCSD
Location: UCSD Hillcrest Nuclear Medicine, Room L-202 (basement level of main hospital) Duration: Total visit is 1-2 hours, with the actual infusion taking 15-30 minutes
Each treatment follows this schedule:
- You'll be taken to a private infusion room
- An IV line will be placed in your arm
- The drug is given through the IV line (takes 5-10 minutes to receive the medicine)
- You'll be monitored for 15-30 minutes after the infusion
- You will be kept at a distance from other patients during treatment
- Safety instructions will be provided before you leave
Important: Family members or friends will not be allowed to be present during your treatment due to radiation safety protocols.
Post-Infusion Imaging
Imaging is acquired 24-72 hours after each infusion to track where Pluvicto went in your body, taking about 45 minutes. This helps your medical team assess treatment effectiveness.
Clinical Results: Proven Benefits
Recent PSMAfore Trial Results
The PSMAfore trial demonstrated that Pluvicto significantly outperformed standard hormone therapy, showing a median radiographic progression-free survival of 12.0 months compared to 5.6 months in the control group. The overall response rate was markedly higher in the Pluvicto group, with more than 7 times more complete responses seen with Pluvicto versus a change in hormone therapy.
Quality of Life Improvements
In the PSMAfore trial, Pluvicto delayed time to worsening in quality of life measures and pain scores. Time to worsening was improved for physical well-being, emotional well-being, and functional well-being.
Side Effects: Detailed Breakdown with Specific Percentages
Most Common Side Effects (from Clinical Trials):
Based on the PSMAfore trial data, here are the specific percentages of patients experiencing side effects:
Primary Side Effects:
- Dry mouth: 61% of patients (mostly Grade 1-2)
- Fatigue: 53% of patients
- Nausea: 32% of patients
- Constipation: 22% of patients
- Anemia (low red blood cell count): 24.2% of patients
- Decreased appetite: Common but percentage varies
- Weight loss: Reported in multiple patients
Serious Side Effects Requiring Medical Attention
Blood Count Changes:
- Low lymphocytes: >30% of patients
- Low hemoglobin: >30% of patients
- Low leukocytes: >30% of patients
- Low platelets: >30% of patients
- Grade 3+ adverse events: 34% of Pluvicto patients vs 44% in control group
Kidney-Related Effects:
- Decreased calcium: >30% of patients
- Decreased sodium: >30% of patients
Managing Side Effects: Specific Strategies
For Dry Mouth (61% of patients):
- Drink plenty of fluids
- Chew and suck on ice chips or hard candy
- Keep good mouth hygiene using alcohol-free mouthwash
- Avoid hot, spicy, acidic foods
For Fatigue (53% of patients):
- Rest often and take naps as needed
- Eat well-balanced meals and drink plenty of fluids
- Light exercise, such as walking, may help
- Do not drive or use machinery when feeling tired
For Low Blood Counts:
- Report any signs of infection, fever, and bleeding or bruising that is not normal
- Call your doctor immediately or go to the closest emergency room if you have a fever over 100.4°F
For Joint or Back Pain:
- You may take acetaminophen (Tylenol) as needed for mild pain
When to Contact Your Medical Team Immediately
Call and Get Help Right Away if You Have:
- A fever of 100.4°F (38°C) or higher
- Difficulty breathing or signs of an allergic reaction
Contact Your Doctor or Nurse if You Have:
- Dizziness
- Any bleeding or bruising that is not normal
- Black colored stools or blood in your stools
- Blood in your urine
- Significant weight loss
- Swelling in arms or legs
Critical Safety Precautions: Protecting Your Family
Critical Safety Precautions: Understanding Evidence-Based vs. Protocol-Based Recommendations
Understanding Radiation Exposure from Pluvicto
Type of Radiation: Lutetium-177 (Lu-177) in Pluvicto primarily emits beta particles, which have important characteristics for patient safety:
- Low penetration power: Beta particles travel only a few millimeters in tissue and are easily stopped by clothing, skin, or even 2.1 mm of plexiglass
- Short range: Unlike gamma rays or X-rays, beta particles don't travel far through air (typically less than a few feet)
- External shielding: The radiation risk is primarily from internal contamination (body fluids) rather than direct radiation from the patient's body
- Time-dependent: Radiation decreases predictably as the Lu-177 decays with a half-life of 6.6 days
Clinical Evidence vs. Current Protocols: Recent studies suggest that current distance and time restrictions may be more conservative than necessary based on Lu-177's beta emission characteristics:
- Measured occupational doses to healthcare workers are consistently low, with annual doses well below safety limits
- Distance effectiveness: Without shielding, dose rates decrease by 88.8% at just 50 cm and achieve ~95% reduction at 100 cm
- Caregiver exposure: Mean effective dose to caregivers in the first 48 hours was only 0.2 mSv (equivalent to a chest X-ray)
- International variations: UK protocols allow 1-hour public transport on discharge day, indicating manageable external risk
Radiation Timeline:
- Within 2 days, over half of the radiation will leave your body
- Within about 14 days, most of the radiation (greater than 99%) will be gone
- Radiation exposure to caregivers is approximately equivalent to 3 cross-country flights (East Coast to West Coast)
Specific Distance and Time Requirements
Distance Requirements:
- Keep at least 3 feet apart from household members for 2 days after infusion
- Keep at least 6 feet apart from pregnant women and children for 7 days at all times
- Practice these distances consistently - brief contact (like a quick hug) is acceptable, but maintain distance most of the time
Sleeping Arrangements:
- Sleep in a separate bedroom from household members for at least 3 days
- Sleep separately from children for 7 days
- Sleep separately from pregnant women for 15 days
Activity Restrictions:
- Abstain from sexual activity for 7 days after each treatment
- Use effective contraception during treatment and for 14 weeks after the final dose
Bathroom and Hygiene Precautions
Immediate Post-Treatment (First 3 Days):
- Use a different bathroom if possible for 3 days
- Drink plenty of fluids and urinate frequently to eliminate radiation from your body
- Flush toilet twice after use and wipe up drips thoroughly
- Always wash hands well with soap and water after using the bathroom
- Flush toilet paper, wipes, and contaminated items down the toilet immediately
Waste Management:
- Items that cannot be flushed (incontinence briefs, bandages) should be put in a designated plastic trash bag
- Store contaminated waste bags for 6 weeks in a location away from others, then dispose as regular trash
- Do not share items that contact your mouth, nose, or saliva
- Do laundry separately from family laundry for the first few days
Travel and Emergency Considerations
Travel Restrictions:
- Minimize time in public places for the first 3 days
- Avoid travel by airplane, mass transportation, or prolonged automobile trips with others for the first 3 days
- If you must travel, sit as far away from other people as possible
- You will receive an information card to carry with you - radiation detectors at airports and ports of entry may detect you for up to 2 weeks
Emergency Preparedness:
- Carry your treatment information card at all times for at least 2 weeks
- If medical emergency occurs during the first week after treatment, show the card to medical personnel
- Contact your health care provider immediately about any signs of myelosuppression (low blood counts) or kidney problems
Radiation Monitoring: Is a Radiation Meter Worthwhile?
Given that Lu-177 primarily emits beta particles with low penetration power, a personal radiation meter is generally not necessary for most patients. However, current protocols may be more conservative than necessary based on the physics of beta radiation.
Beta Radiation Characteristics:
- Low external radiation risk: Beta particles from Lu-177 don't penetrate far enough to create significant external radiation exposure
- Primary concern is contamination: The main risk comes from body fluids (urine, saliva, sweat) that contain Lu-177, not direct radiation from your body
- Minimal shielding required: Even 2.1 mm of Perspex (plexiglass) stops 0.5 MeV beta particles completely, and standard clothing provides adequate protection
Evidence-Based Distance Requirements: Recent clinical studies suggest that current distance restrictions may be overcautious:
- At 100 cm (about 3 feet) from Lu-177 patients, measured occupational doses were minimal, with annual occupational doses well below 20 mSv limits
- Without any shielding, dose rates decreased by 88.8% at just 50 cm from the radiation source
- A reduction of approximately 95% is observed at distances greater than 100 cm without any protective equipment
Clinical Practice Reality:
- Most sites perform Lu-177 therapy on an outpatient basis in standard nuclear medicine rooms, sometimes even general infusion rooms, without special shielding
- Mean effective dose to caregivers in the first 48 hours was only 202.0 ± 43.0 μSv (0.2 mSv)
- UK protocols allow patients to limit public transport travel to just 1 hour on discharge day, indicating low external radiation risk
Protocols Designed for Higher-Energy Emitters: The conservative distance and time restrictions appear to be adapted from protocols designed for:
- I-131 therapy (gamma emitter with much higher energy and penetration)
- High-dose brachytherapy implants (sealed sources with different risk profiles)
- Historical precedent rather than Lu-177-specific physics
Consumer Radiation Meters Have Significant Limitations:
- Most consumer Geiger counters detect gamma rays poorly suited for beta detection
- Beta radiation detectors require special windows and calibration
- Professional contamination survey meters with pancake-style GM detectors use approximately 20% efficiency for direct surface contamination readings
- Could cause unnecessary anxiety with inaccurate readings
More Effective Approach:
- Focus on contamination control rather than radiation detection
- Only 4 mm of lead shielding is needed to reduce radiation levels to 1 mR/h for handling, indicating very manageable radiation levels
- Beta particles are easily blocked - normal clothing and minimal distance provide excellent protection
- Trust the established medical protocols, while recognizing they may be more conservative than the physics requires
- Contact your radiation safety officer with specific concerns rather than relying on consumer equipment
Key Clinical Insight: The safety precautions for Pluvicto appear to be more conservative than necessary based on Lu-177's beta emission profile. The protocols may reflect institutional caution and regulatory conservatism rather than physics-based requirements. The economic and practical advantages of Lu-177 over higher energy gamma emitters like I-131 are significant, yet protocols often remain similarly restrictive.
Monitoring During Treatment
Your healthcare provider will usually do regular blood tests and scans to see how well your body is responding to the treatment. Blood tests will monitor your blood counts, such as white blood cells, neutrophils, and platelets, to ensure you can continue to use Pluvicto safely.
Other tests may include PSA (prostate-specific antigen), which is often used to monitor prostate cancer and how active it is in your body.
Fertility Considerations
Pluvicto can harm an unborn baby and may cause temporary or permanent infertility in men. Use effective contraception while being treated with Pluvicto and for 14 weeks after your last dose.
Transportation Options for Pluvicto Patients
Given the post-treatment radiation safety restrictions that limit driving for some patients, transportation planning is crucial for the 8-month treatment schedule.
Public Transportation to UCSD Hillcrest
Bus Routes Serving Hillcrest Medical Center:
- Route 3, 10, 11, 83 all stop near the medical center
- Nearest bus stop: Front St & Arbor Dr (UCSD) - only 2 minutes walk to Nuclear Medicine
- Trolley access: BLUE and GREEN lines serve the area
- Service hours: First bus at 4:41 AM, last bus at 12:08 AM
- Accessibility: All MTS buses and trolleys have ADA-compliant wheelchair ramps or lifts
Post-Treatment Considerations:
- Limited public transport: UK protocols suggest limiting public transport to 1 hour on discharge day
- Distance requirements: Maintain 3 feet from other passengers for 2 days post-treatment
- Private transport preferred for safety compliance during restriction period
Medical Transportation Services
UCSD Health Provided Services:
- Wheelchair van: $80 plus $5 per mile
- Gurney transport: $145 plus $7 per mile (for patients who cannot sit up)
- Availability: Schedule through your medical team
- Coverage: Note that not all forms of medical transport are covered by health plans
Private Medical Transport Companies:
Valley Medical Transport
- Services: Ambulatory, wheelchair, and gurney transportation
- Service area: San Diego and Imperial County
- Features: Professional drivers, comprehensive training, wheelchair certification
- Contact: Available for routine medical appointments
- Reliability: Emphasis on punctuality for medical appointments
Happy2Help Transportation
- Specialty: Non-emergency medical transportation
- Features: ADA-compliant wheelchair ramps and Q-straint tie downs
- Vehicle types: Wheelchair accessible vans and sedan vehicles
- Service area: San Diego County
- Personal touch: Founded by in-home care professional
Comfort Ride Transport
- Services: Non-emergency medical and private transportation
- Options: Ambulatory, wheelchair, and gurney transportation
- Features: Reliable, comfortable service
- Notice: 72 hours advance notice for trips outside local areas
Senior and Disability Transportation Resources
FACT (Facilitating Access to Coordinated Transportation)
- Eligibility: Seniors 60+, persons with disabilities, students, veterans
- Service: Essential trips for medical and grocery needs
- Booking: Call 8:00 AM - 3:00 PM, Monday-Friday
- Advance notice: At least one day ahead preferred
- Accessibility: Accommodates wheelchairs and scooters
San Diego County Senior Transportation Program
- Provider: County partnership with On the Go
- Eligibility: Older adults in specific low-income areas (0-50% quartile on California Healthy Places Index)
- Cost: No cost to eligible riders
- Allowance: Up to 100 miles per month
- Contact: 855-638-2279 or visit otgrides.org/sd-enrollment
MTS Access (Paratransit)
- Eligibility: Certified individuals unable to use fixed-route transit
- Service area: Within ¾-mile radius of bus routes/trolley stations
- Booking: 888-517-9627 (make reservations 24-48 hours in advance)
- Certification required: Call 877-232-7433 for certification process
Rideshare and Private Options
Standard Rideshare Services:
- Uber/Lyft: Available but consider radiation safety restrictions
- Post-treatment limitations: May not be appropriate during 2-3 day restriction period
- Distance requirements: Difficulty maintaining 3-foot distance in standard vehicles
Specialized Transportation:
- SureRide Executive Transportation: 619-517-5283 (ADA-compliant mini-coach)
- SOL Transportation: 866-765-3177 (ambulatory and wheelchair services)
Insurance and Payment Considerations
Coverage Options:
- Medicare: May cover medically necessary transportation
- Medi-Cal: Transportation services available (contact DHCS for details)
- Private insurance: Varies by plan - check with your provider
- Out-of-pocket: Many services available for private pay
Cost Planning: For the complete 6-treatment schedule, budget for approximately 12-18 round trips (treatments + imaging + potential additional appointments).
Planning Recommendations
Before Treatment Begins:
- Assess your transportation needs for the full 8-month period
- Contact your insurance to understand covered transportation options
- Arrange backup transportation for post-treatment restriction periods
- Consider proximity - choose services familiar with UCSD Hillcrest location
- Schedule transportation when you schedule treatment appointments
Post-Treatment Safety:
- Plan for restrictions: Arrange different transportation home than to treatment
- Caregiver transportation: Brief contact acceptable, but maintain distance protocols
- Emergency transport: Keep contact information for medical transport services
UCSD Health System Resources
Primary Treatment Location
UCSD Hillcrest Nuclear Medicine
- Address: 200 W. Arbor Dr. San Diego, CA 92103
- Phone: 619-543-1985
- Location: Main hospital lower level (basement) room L-202
- Directions: Take the elevator from the lobby down to the lower level to room L-202
- Valet parking: Available 8 a.m.-4:30 p.m. weekdays at main entrance on Arbor Drive
UCSD Lab Locations for Pre-Treatment Blood Work
You can complete required lab work 5-7 days before each infusion at any of these convenient UCSD locations:
Hillcrest Area:
- Medical Offices North (inside main hospital): Room 1-333, Monday–Friday: 7:30 a.m.–5 p.m., Sunday: 7–10:30 a.m.
- Medical Offices South: 4168 Front St., Room 1-129, Monday–Friday: 8 a.m.–4:30 p.m.
- 4th and Lewis Medical Offices: 330 Lewis St., Suite 402, Monday–Friday: 7:30 a.m.–4:30 p.m. (Appointment required)
La Jolla Area:
- Perlman Medical Offices: 9350 Campus Point Drive, Monday–Friday: 7:30 a.m.–6 p.m.
- 8910 Villa La Jolla Drive: Monday–Friday: 7 a.m.–8 p.m., Saturday–Sunday: 8 a.m.–12 p.m.
- Moores Cancer Center: 3855 Health Sciences Drive, Monday–Friday: 7:30 a.m.–5 p.m.
North County:
- Rancho Bernardo - Via Tazon: 16950 Via Tazon, Monday–Friday: 7 a.m.–5 p.m. (Walk-ins or appointments accepted)
- Scripps Ranch: 9909 Mira Mesa Blvd., Suite 200, Monday–Friday: 8 a.m.–5 p.m. (Appointment required)
- Encinitas: 1200 Garden View Road, Second Floor, Monday–Friday: 8:30 a.m.–4 p.m. (Appointment required)
- Vista: 910 Sycamore Ave., Suite 102, Monday–Friday: 8:30 a.m.–4 p.m. (Appointment required)
Contact Information
- Department of Radiology: Molecular Imaging and Therapeutics: 619-471-3933
- Nuclear Medicine scheduling: 619-543-1985
Future Developments
Novartis is investigating Pluvicto in even earlier stages of disease, including metastatic hormone-sensitive prostate cancer (PSMAddition trial) and oligometastatic prostate cancer (PSMA-DC trial). Recent results show potential for treatment in these earlier settings.
Sample Treatment Schedule: Complete Pluvicto Protocol Timeline
Based on UCSD Health System protocols - treatment starting January 6, 2026
| Week | Date | Appointment Type | Location | Duration | Notes |
|---|---|---|---|---|---|
| Pre-Treatment | Dec 30, 2025 | Nuclear Medicine Consult | Telephone Call | 45 minutes | Initial consultation and planning |
| -1 | Jan 2, 2026 | Lab Work (Pre-Infusion 1) | UCSD Lab* | 10 minutes | CBC, CMP, kidney function 5-7 days prior |
| 0 | Jan 6, 2026 | INFUSION 1 | Hillcrest Nuclear Medicine L-202 | 2 hours | First treatment dose |
| 0 | Jan 7, 2026 | Post-Infusion Imaging 1 | Hillcrest Nuclear Medicine L-202 | 45 minutes | 24-72 hours post-infusion |
| 5 | Feb 11, 2026 | Lab Work (Pre-Infusion 2) | UCSD Lab* | 10 minutes | Blood count monitoring |
| 6 | Feb 17, 2026 | INFUSION 2 | Hillcrest Nuclear Medicine L-202 | 2 hours | Second treatment dose |
| 6 | Feb 18, 2026 | Post-Infusion Imaging 2 | Hillcrest Nuclear Medicine L-202 | 45 minutes | 24-72 hours post-infusion |
| 11 | Mar 25, 2026 | Lab Work (Pre-Infusion 3) | UCSD Lab* | 10 minutes | Blood count monitoring |
| 12 | Mar 31, 2026 | INFUSION 3 | Hillcrest Nuclear Medicine L-202 | 2 hours | Third treatment dose |
| 12 | Apr 1, 2026 | Post-Infusion Imaging 3 | Hillcrest Nuclear Medicine L-202 | 45 minutes | 24-72 hours post-infusion |
| 17 | May 6, 2026 | Lab Work (Pre-Infusion 4) | UCSD Lab* | 10 minutes | Blood count monitoring |
| 18 | May 12, 2026 | INFUSION 4 | Hillcrest Nuclear Medicine L-202 | 2 hours | Fourth treatment dose |
| 18 | May 13, 2026 | Post-Infusion Imaging 4 | Hillcrest Nuclear Medicine L-202 | 45 minutes | 24-72 hours post-infusion |
| 23 | Jun 17, 2026 | Lab Work (Pre-Infusion 5) | UCSD Lab* | 10 minutes | Blood count monitoring |
| 24 | Jun 23, 2026 | INFUSION 5 | Hillcrest Nuclear Medicine L-202 | 2 hours | Fifth treatment dose |
| 24 | Jun 24, 2026 | Post-Infusion Imaging 5 | Hillcrest Nuclear Medicine L-202 | 45 minutes | 24-72 hours post-infusion |
| 29 | Jul 29, 2026 | Lab Work (Pre-Infusion 6) | UCSD Lab* | 10 minutes | Blood count monitoring |
| 30 | Aug 4, 2026 | INFUSION 6 | Hillcrest Nuclear Medicine L-202 | 2 hours | Final treatment dose |
| 30 | Aug 5, 2026 | Post-Infusion Imaging 6 | Hillcrest Nuclear Medicine L-202 | 45 minutes | 24-72 hours post-infusion |
| 36 | Sep 16, 2026 | Follow-up Assessment | Oncology Clinic | 60 minutes | Response evaluation, PSA, imaging review |
| 48 | Dec 9, 2026 | 3-Month Follow-up | Oncology Clinic | 45 minutes | Long-term response assessment |
Additional Physician Consultations (As Needed):
- Medical Oncology visits: Typically every 6-12 weeks during treatment
- Radiation Safety consultations: After each infusion for safety instruction review
- Emergency consultations: Any time for fever >100.4°F, significant side effects, or complications
Key Schedule Notes:
- Total treatment duration: 8 months (30 weeks)
- Lab work timing: Must be completed 5-7 days before each infusion
- Post-infusion imaging: Scheduled 24-72 hours after each treatment
- Safety precautions: Required for 2-7 days after each infusion (see radiation safety guidelines)
- Flexibility: Dates may be adjusted based on blood counts, side effects, or scheduling conflicts
*Any UCSD lab location convenient for patient (see UCSD Lab Locations section)
UCSD Contact Information:
- Nuclear Medicine Scheduling: 619-543-1985
- Molecular Imaging and Therapeutics: 619-471-3933
- Location: 200 W. Arbor Dr. San Diego, CA 92103, Room L-202 (basement level)
SIDEBAR: Patient Case Study - Timing Pluvicto Treatment
A common question from IPCSG members currently on standard therapy
The Situation:
Patient Profile: Currently on Lupron (ADT) + Enzalutamide (ARPI), post-radical prostatectomy and radiation, PSA 0.75, mild anemia from current treatment.
Question: "When would it be appropriate to start Pluvicto, and how will my current treatment be modified? Should I treat my anemia preventively?"
Clinical Considerations:
Pluvicto Eligibility Under New 2025 Criteria:
- PSMA-positive status (requires PSMA PET scan confirmation)
- Progression on ARPI therapy (Enzalutamide)
- Appropriate to delay chemotherapy (no longer requires prior chemo failure)
Timing Indicators to Watch:
- PSA progression despite optimal ADT + ARPI therapy
- Radiographic progression on imaging studies
- Clinical progression (new symptoms, bone pain)
- PSA doubling time and progression pattern trends
Treatment Modifications When Starting Pluvicto:
- Lupron (ADT) continues - castrate testosterone levels must be maintained
- Enzalutamide may be discontinued - clinical trials compared Pluvicto vs. continuing ARPI
- Decision based on individual clinical situation
Managing Pre-Existing Anemia: Your oncologist should evaluate:
- Current hemoglobin levels and CBC trends
- Cause of anemia (ADT/Enzalutamide vs. other factors)
- Severity assessment (Grade 1-2 may not preclude treatment)
Potential Preventive Measures:
- Iron supplementation if deficiency present
- Blood count optimization before Pluvicto
- Enhanced monitoring schedule during treatment
- Possible erythropoiesis-stimulating agents in select cases
Critical Next Steps:
- PSMA PET scan to determine PSMA-positive status
- Disease progression assessment - PSA trends, imaging studies
- Blood work optimization - CBC, iron studies, kidney function
Key Questions for Your Oncologist:
- "What PSA progression rate would trigger Pluvicto consideration?"
- "Should we get a PSMA PET scan now to establish baseline?"
- "How would my current anemia affect treatment eligibility?"
- "What blood count thresholds are required for Pluvicto?"
Bottom Line: You may be a candidate under the expanded 2025 criteria, but PSMA-positive confirmation and progression assessment are needed first. Mild anemia is likely manageable with proper evaluation and monitoring.
Key Takeaways for Patients
- Eligibility: You must have PSMA-positive tumors confirmed by a PSMA PET scan
- Treatment Schedule: 6 infusions over approximately 8 months, each 6 weeks apart
- Family Planning: Strict safety precautions are required after each treatment to protect others
- Side Effects: Generally well-tolerated with mostly mild to moderate side effects
- Monitoring: Regular blood tests and scans will track your response to treatment
- Support: Patient support services are available to help with insurance and financial assistance
Sources and References
- University of Chicago Medicine. (2025). Lutetium-177 PSMA Therapy for Prostate Cancer (Pluvicto). https://www.uchicagomedicine.org/cancer/types-treatments/prostate-cancer/treatment/lutetium-177-psma-therapy-for-prostate-cancer
- Tulchinsky, M. et al. (2022). Breakthrough nuclear medicine treatment helps patients with advanced prostate cancer. Medical Update, Penn State Health. https://medicalupdate.pennstatehealth.org/urology-surgery/novartis-pluvicto/
- The University of Kansas Cancer Center. (2025). Pluvicto Therapy. https://www.kucancercenter.org/cancer/cancer-treatments/pluvicto
- U.S. Food and Drug Administration. (2025). FDA expands Pluvicto's metastatic castration-resistant prostate cancer indication. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-expands-pluvictos-metastatic-castration-resistant-prostate-cancer-indication
- Novartis. (2025). FDA approves Novartis radioligand therapy Pluvicto® for earlier use before chemotherapy in PSMA-positive metastatic castration-resistant prostate cancer. https://www.novartis.com/news/media-releases/fda-approves-novartis-radioligand-therapy-pluvicto-earlier-use-chemotherapy-psma-positive-metastatic-castration-resistant-prostate-cancer
- UVA Health. (2025). Pluvicto™ Prostate Cancer Treatment. https://uvahealth.com/services/imaging/nuclear-imaging/pluvicto
- Harvard Health Publishing. (2022). New treatment approved for late-stage prostate cancer. https://www.health.harvard.edu/blog/new-treatment-approved-for-late-stage-prostate-cancer-202204072722
- U.S. Food and Drug Administration. (2022). FDA approves Pluvicto for metastatic castration-resistant prostate cancer. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pluvicto-metastatic-castration-resistant-prostate-cancer
- WebMD. (2024). How Pluvicto Fights Prostate Cancer and What to Expect. https://www.webmd.com/prostate-cancer/pluvicto-prostate-cancer
- Novartis. (2023). Novartis Pluvicto™ shows clinically meaningful and highly statistically significant rPFS benefit in patients with PSMA-positive metastatic castration-resistant prostate cancer in the pre-taxane setting. https://www.novartis.com/news/media-releases/novartis-pluvictotm-shows-clinically-meaningful-and-highly-statistically-significant-rpfs-benefit-patients-psma-positive-metastatic-castration-resistant-prostate-cancer-pre-taxane-setting
- Healthline. (2025). Pluvicto: Side Effects and How to Manage Them. https://www.healthline.com/health/drugs/pluvicto-side-effects
- Global Pluvicto Safety Information. (2025). https://www.global.pluvicto.com/safety-information
- Drugs.com. (2025). Pluvicto Side Effects: Common, Severe, Long Term. https://www.drugs.com/sfx/pluvicto-side-effects.html
- Healthline. (2024). Pluvicto: Uses, Side Effects, Dosage, and More. https://www.healthline.com/health/drugs/pluvicto
- Medical News Today. (2024). Pluvicto: Side effects, dosage, uses, interactions, cost, and more. https://www.medicalnewstoday.com/articles/drugs-pluvicto
- Medical News Today. (2025). Pluvicto side effects: Common, mild, and serious. https://www.medicalnewstoday.com/articles/drugs-pluvicto-side-effects
- Novartis. (2025). What to Expect With PLUVICTO Treatment. https://us.pluvicto.com/about-pluvicto/what-to-expect-with-pluvicto-treatment
- Memorial Sloan Kettering Cancer Center. (2025). About Your Pluvicto™ Treatment. https://www.mskcc.org/cancer-care/patient-education/about-your-pluvicto-treatment
- Novartis. (2025). Novartis Pluvicto™ demonstrates statistically significant and clinically meaningful rPFS benefit in patients with PSMA-positive metastatic hormone-sensitive prostate cancer. https://www.novartis.com/news/media-releases/novartis-pluvictotm-demonstrates-statistically-significant-and-clinically-meaningful-rpfs-benefit-patients-psma-positive-metastatic-hormone-sensitive-prostate-cancer
- OncoDaily. (2025). FDA Approved Pluvicto (177Lu-PSMA-617) for Metastatic Castration-Resistant Prostate Cancer. https://oncodaily.com/oncolibrary/pluvicto-fda-approval
- Precision Medicine Online. (2023). Pluvicto Delays Progression in Earlier mCRPC, but Crossover Muddies Overall Survival Analysis. https://www.precisionmedicineonline.com/precision-oncology/pluvicto-delays-progression-earlier-mcrpc-crossover-muddies-overall-survival
- Fierce Pharma. (2023). ESMO: Novartis' booming Pluvicto posts mixed results in earlier prostate cancer. https://www.fiercepharma.com/pharma/novartis-booming-pluvicto-posts-hot-and-cold-results-earlier-prostate-cancer
- Fierce Pharma. (2024). Novartis finally ready for Pluvicto filing in earlier prostate cancer as patient survival data clear up. https://www.fiercepharma.com/pharma/novartis-finally-ready-pluvicto-filing-earlier-prostate-cancer-patient-survival-data-clear
- UroToday. (2024). ASCO 2024: PSMAfore: HRQoL and Pain in a Phase 3 Study of 177Lu-PSMA-617 in Taxane-Naïve Patients with mCRPC. https://www.urotoday.com/conference-highlights/asco-2024/asco-2024-prostate-cancer/152475-asco-2024-psmafore-hrqol-and-pain-in-a-phase-3-study-of-177lu-psma-617-in-taxane-naive-patients-with-mcrpc.html
- UC San Diego Health System. (2025). PLUVICTO™ (Lu-177 PSMA) Patient Guide. Department of Radiology: Molecular Imaging and Therapeutics. Internal patient education document.
- Advanced Accelerator Applications. (2022). PLUVICTO™ Patient Information Booklet. Comprehensive patient guide with clinical trial data and safety information.
- UC San Diego Health System. (2025). PLUVICTO Patient Instructions - Radiation Safety Guidelines. Department of Radiology: Molecular Imaging and Therapeutics. Internal safety protocol document
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