Cytalux™ for Prostate Cancer
Recruiting in Palo Alto (17 mi)
+2 other locations
Overseen byClinton Bahler, MD
Age: 18+
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: Clinton Bahler
Disqualifiers: Extraperitoneal approach, Anaphylactic reactions, Allergy to pafolacianine, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?
This study is being done to compare how much using Cytalux™ (pafolacianine) with NIR (Near InfraRed) fluorescent imaging improves the detection of malignant (growing in an uncontrolled way) tissue in adult subjects undergoing prostatectomy and lymph node dissection for biopsy confirmed prostate cancer. The U.S. Food and Drug Administration (FDA) has approved the targeted imaging agent pafolacianine (Cytalux) for use in ovarian cancer (2021) and lung cancer surgery (2022.)
Will I have to stop taking my current medications?
The trial requires participants to stop taking folate or folic acid supplements at least 48 hours before receiving the study agent. Other medications are not specifically mentioned, so it's best to discuss with the trial team.
How does the drug Cytalux™ differ from other prostate cancer treatments?
Eligibility Criteria
This trial is for adults with biopsy-confirmed prostate cancer who are undergoing prostatectomy and lymph node dissection. Details about specific inclusion or exclusion criteria are not provided, but typically participants must meet certain health standards and not have conditions that would interfere with the study.Inclusion Criteria
I am a man aged 18 or older.
Signed and dated informed consent form
My prostate cancer is aggressive and may have spread beyond the prostate.
See 3 more
Exclusion Criteria
My surgeon will operate outside the peritoneal cavity.
Any medical condition that in the opinion of the investigators could potentially jeopardize the safety of the subject
History of anaphylactic reactions to products containing indocyanine green
See 1 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo laparoscopic radical prostatectomy with NIR imaging using pafolacianine
1 day
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after surgery
4 weeks
Treatment Details
Interventions
- CYTALUX™ (Virus Therapy)
Trial OverviewThe trial is testing Cytalux™ (pafolacianine) used alongside NIR fluorescent imaging to see if it helps better identify cancerous tissue during surgery in patients with prostate cancer. The FDA has previously approved this agent for ovarian and lung cancer surgeries.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Pafolacianine injection and surgeryExperimental Treatment2 Interventions
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Indiana University Health Melvin and Bren Simon Comprehensive Cancer CenterIndianapolis, IN
IU Health Joe and Shelly Schwarz Cancer CenterCarmel, IN
Indiana University Health Methodist HospitalIndianapolis, IN
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Who Is Running the Clinical Trial?
Clinton BahlerLead Sponsor
Indiana UniversityLead Sponsor
On Target LaboratoriesCollaborator
On Target Laboratories, LLCIndustry Sponsor
References
[New drugs at the horizon for men with prostate cancer]. [2010]Despite major progress in the understanding of biological mechanisms underlying metastatic prostate cancer, the treatment of men with advanced prostate cancer remains challenging. Several randomized controlled trials with promising or positive results are underway or just released. Here we discuss new treatments which might be used in clinic in the near future: hormonal treatments (Abiraterone and MDV3100), a new chemotherapy (Cabazitaxel), a cellular vaccine (Sipuleucel-T), anti-angiogenic drugs (Bevacizumab, Aflibercept), a new radioactive treatment (Alpharadin) and a new bone-protective agent (Deno-sumab).
Phase 3 HERO Trial Finds Relugolix to Be Superior to Leuprolide in Prostate Cancer. [2021]Results from the phase 3 HERO trial(NCT03085095), presented during the 2020 American Society of Clinical Oncology Virtual Scientific Program, indicated that relugolix (Relumina) demonstrated superiority over leuprolide (Lupron) in sustained testosterone suppression through 48 weeks, fast testosterone recovery after discontinuation, and a 50% reduction in major adverse cardiovascular events (MACE) in patients with advanced prostate cancer.
Treatment of prostate cancer. [2005]The epidemiology, histopathology, diagnosis and staging, and treatment of prostate cancer are reviewed. Prostate cancer, one of the most common malignancies occurring in men over age 50, will strike an estimated 103,000 men in the United States in 1989. More than 95% of prostatic tumors are adenocarcinomas. Tumors are graded on the basis of their degree of differentiation. Most afflicted men initially complain of difficulty in starting the urinary stream and of urinary bleeding, dribbling, and retention. Urinary obstruction may be present in advanced disease, and anemia, anorexia, and bone pain are common in metastatic disease. Prostatectomy and irradiation are used to treat disease localized to the prostate; the prognosis for such patients is good. Survival is diminished in cases of locally advanced and metastatic disease. Symptomatic metastatic disease is treated by hormonal manipulation through orchiectomy and administration of exogenous estrogens (diethylstilbestrol), luteinizing hormone-releasing hormone analogs (leuprolide and goserelin), and antiandrogens (cyproterone acetate, flutamide, and others). Some 70-80% of patients respond to hormonal therapy for periods of up to three years. After relapse occurs, salvage hormonal therapies (aminoglutethimide and ketoconazole) may be attempted to prolong survival. Fluorouracil, doxorubicin, mitomycin, cisplatin, cyclophosphamide, methotrexate, and estramustine have also been administered, with mixed results. Once relapse occurs in prostate cancer patients after initial hormonal therapy, the response to salvage hormonal or cytotoxic therapy is minimal; in the future, total androgen blockade and methods of decreasing drug resistance may be used to prolong survival.
Maximum androgen blockade using LHRH agonist buserelin in combination with short-term (two weeks) or long-term (continuous) cyproterone acetate is not superior to standard androgen deprivation in the treatment of advanced prostate cancer. Final analysis of EORTC GU Group Trial 30843. European Organization for Research and Treatment of Cancer (EROTC) Genito-Urinary Tract Cancer Cooperative Group. [2019]This is the final analysis of EORTC GU Group Trial 30843 in which the treatment of advanced, metastatic prostate cancer with a combination of the LHRH agonist buserelin (nasal spray) and cyproterone acetate (Androcur), either continuously of only during the first 2 weeks, was compared with orchidectomy. There was no significant difference between the three arms as far as response rate, time to progression (subjective and objective) and duration of survival are concerned. Retrospective stratification according to the most important prognostic factors did not change the conclusions. Possible reasons for the difference with trial 30853, which used the same entry criteria but compared goserelin and flutamide with orchidectomy, are discussed. Reasons for using cyproterone acetate in combination treatment are the prevention of flare of the disease after LHRH agonists only and the prevention/reduction of toxicity in the form of hot flushes.
Zoladex with or without flutamide in the treatment of locally advanced or metastatic prostate cancer: interim analysis of an ongoing PONCAP study. Italian Prostatic Cancer Project (PONCAP). [2019]Since March 1987, 304 evaluable patients with stage C and D prostate cancer have been entered into a prospective trial comparing Zoladex and Zoladex plus flutamide. To date, there has been no significant difference in over-all and progression-free survival between the 2 treatment groups. However, combined treatment produced a higher response rate (particularly in stage D patients) and a more rapid normalization of abnormal prostatic acid phosphatase levels. In addition, more prompt relief of bone pain was evident in the Zoladex plus flutamide group. However, significantly more side-effects were associated with combined treatment. These findings should be considered with caution because they form an interim analysis, and follow-up time is short. The results do suggest, however, that there is no particular advantage in using a combination of Zoladex plus flutamide compared to adding flutamide on failure of treatment with Zoladex alone.