Update: New drug approved for metastatic prostate cancer
The FDA approved a new treatment for metastatic castration-resistant prostate cancer. They also approved a test that can be used to identify patients who would benefit from this new treatment. (Posted 5/10/22)
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Contents
At a glance | Questions for your doctor |
Study findings | Clinical trials |
Strengths and limitations | Related resources |
What does this mean for me? | |
UPDATE AT A GLANCE
What is this update about?
This update is about approval of the drug Pluvicto for treating people with castration-resistant cancer (mCRPC). The also approved a drug called Locametz that can be used with imaging to identify patients who will likely benefit from treatment with Pluvicto.
Why is this update important?
castration-resistant cancer remains incurable, although many types of drugs delay progression and prolong life.
Pluvicto (177Lu-PSMA-617) is a drug that delivers radiation directly to tumor cells that express a protein known as PSMA. PSMA (also known as ) is found at low levels in normal cells but it is found at high levels in some cancer cells. Pluvicto works on tumor cells that have increased PSMA.
The also approved Locametz (Ga 68 PSMA-11) to detect PSMA levels in cancer cells that have spread throughout the body. For more information on the approval of this imaging drug, read our XRAY review here. Imaging with Locametz can determine if a person’s cancer is likely to respond to Pluvicto.
Study findings
The approval was based on the results of the VISION trial. VISION compared patients who were treated with Pluvicto and protocol-permitted standard care or protocol-permitted standard care alone. Standard-care therapy that was permitted included approved hormonal treatments (including and ), bisphosphonates, radiation therapy, denosumab, or glucocorticoid at any dose. Standard-care excluded chemotherapy, , radium-223 (223Ra), and investigational drugs. All the participants had prior treatment with an androgen receptor pathway inhibitor and chemotherapy and had tumors that expressed high levels of PSMA. High levels of PSMA were defined as at least one PSMA-positive lesion and no PSMA-negative lesions. PSMA-positive status was determined with the use of -68 (68Ga)–labeled PSMA-11 (68Ga-PSMA-11) PET–CT imaging.
Patients treated with Pluvicto had significantly improved overall and progression-free survival. Among patients treated with Pluvicto plus standard of care:
- Overall survival was 15.3 months compared to 11.3 months for patients treated with standard of care alone.
- Progression-free survival was 8.7 months compared to 3.4 months for patients treated with standard of care alone.
Almost 57 percent of participants who were treated with Pluvicto had an of grade 3 or higher compared to 38 percent of participants who were treated with standard of care alone. Garde 3 adverse events were defined as severe or medically significant but not immediately life-threatening. The most common adverse events were:
- Fatigue
- Dry mouth
- Nausea
- Anemia
- Decreased appetite
- Constipation
However, participants who were treated with Pluvicto did not report that their quality of life was adversely affected.
Strengths and limitations
Strengths
- The VISION trial included almost 600 participants.
- The imaging criteria that was used in this trial allowed patients with PSMA-positive castration-resistant cancer to receive life-extending therapy on the basis of only one plus conventional imaging.
Limitations
- Adverse events were defined as occurring during the treatment period for up to 30 days after the last dose of Pluvicto or standard-of-care treatment. The 30-day post-dose period for such adverse events may have led to underestimating adverse events.
- Most (87%) of enrolled patients were white.
- The study was not blinded or controlled so many patients left the study if they didn’t get Pluvicto.
What does this mean for me?
In most patients with mCRPC, lesions are positive for PSMA. Treatments like Pluvicto are begin developed to target cancer cells while sparing healthy cells.
If you have been diagnosed with mCRPC and have previously been treated with and androgen receptoro pathway inhibitor and chemotherapy, then you may be eligible for additional imaging with Locametz to see if you would benefit from treatment with Pluvicto.
References
approves Pluvicto for castration-resistant cancer. www.fda.gov, March 23, 2022.
Sartor O, de Bono J, Chi KN, Fizazi K, et al. Lutetium-177-PSMA-617 for Castration-Resistant Cancer. N Engl J Med. 2021 Sep 16;385(12):1091-1103. Epub 2021 Jun 23.
Disclosure: FORCE receives funding from industry sponsors, including companies that manufacture cancer drugs, tests and devices. All XRAYS articles are written independently of any sponsor and are reviewed by members of our Scientific Advisory Board before publication to assure scientific integrity.
Share your thoughts on this XRAY review by taking our brief survey.
posted 5/10/22
- Am I a candidate for PSMA imaging?
- Am I a candidate for PSMA-targeted therapy?
- Am I a candidate for other therapies for mCRPC, such as a ?
- Should I have genetic testing?
- Should I have tumor testing?
The following treatment studies are enrolling people with advanced cancer:
- NCT05011383: High Dose Testosterone Treatment for People with Prostate Cancer and an , CDK12 or Mutation. This study will examine how well an increased dose of testosterone treatment works for people with castration-resistant cancer (mCRPC) with an , CDK12, or genetic mutation.
- NCT05367440: Treating Prostate Cancer with a New AZD5305 Combined With Hormone Therapy. This study will look at the effectiveness of a new drug called AZD5305 in combination with different hormone therapies to treat prostate cancer, compared to the current standard treatment.
- NCT04038502: Treating Prostate Cancer with Chemotherapy or in People with Mutations (COBRA). This study is comparing carboplatin chemotherapy to the , as treatment for castration-resistant cancer in people with a , , , , CHEK1, FANCL, , RAD51B, , or RAD54L mutation.
- NCT06120491: Studying the Effectiveness of New , Saruparib Compared to Current Treatment Options for Prostate Cancer EvoPAR-PRO1. This study will evaluate an investigational drug called Saruparib in combination with new hormonal agents to treat prostate cancer compared to standard treatment in people whose tumors have a mutation in: , , , , CDK12, , RAD51B, , or .
The following studies are enrolling people with advanced , including cancer:
- NCT06545942: Treating Advanced Cancers with or Other Related Gene Mutations Using MOMA-313 Alone or In Combination with the Olaparib. This trial will study MOMA-313 given alone or together with a () in people with certain advanced or cancers with the following mutations: , , , , , CDK12, CHEK1, , FANCL, , RAD51B, , , and/or RAD54L.
- NCT05932862: Study of a New InvestigationaI Inhibitor to Treat People with Advanced . The study examines the safety and effectiveness of the investigational treatment XL309 when used alone or in combination with a to treat people with some advanced , including cancer.
- NCT05417594: Study of the AZD9574 Alone and Combined with Other Cancer Medicines to Treat People with Advanced Solid Cancers (CERTIS1 Study). This study looks at a new AZD9574 given alone and in combination with other anti-cancer drugs for people with advanced cancer that has come back or progressed.
Other clinical trials for people with cancer can be found here.
Updated: 10/03/2025
The following organizations offer peer support services for people with or at high risk for cancer:
- FORCE peer support
- Visit our message boards.
- Once you register, you can post on the Diagnosed With Cancer board to connect with other people who have been diagnosed.
- Sign up for our Peer Navigation Program.
- Users are matched with a volunteer who shares their mutation and situation.
- Join our private Facebook group.
- Find a virtual or in-person support meeting.
- Join a Zoom community group meeting.
- Visit our message boards.
- ZERO-The End of Cancer is a nonprofit organization that provides information and support resources for men with cancer.
Updated: 03/08/2023