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RITA Supports For Cancer Treatment

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Following is the eligibility criteria for mCRPC IND:

Inclusion Criteria:

1. Signing informed consent.
2. Adenocarcinoma of Prostate proven by histopathology
3. Life expectancy of 6 months or more.
4. Unresectable metastases.
5. Progressive disease, with docetaxel/cabazitaxel or declined taxane therapy by the patient.
6. 177 Lu-PSMA-617 naive or 177Lu-PSMA-617/177Lu-PSMA-I&T treated.
7. If BRCA mutations or microsatellite instability is present, patients should have received FDA approved therapies such as PARP inhibitors and pembrolizumab, and progressed.
8. Castration resistant disease with confirmed testosterone level ≤50 ng/mlunder prior androgen deprivation therapy (ADT)
9. Positive 68Ga-PSMA-11 PET/CT for the majority of measurable disease defined as SUV ≥2.0.
10. ECOG 0-2
11. Hemoglobin concentration ≥ 9.0 g/dL
12. Platelet counts ≥100 x 10⁹/L
13. White blood cell count ≥ 2.0 x 10⁹/L), ANC>1.5 x 10⁹/L
14. Glomerular Filtration Rate (GFR) ≥ 60 ml/min
15. AST and ALT ≤ 5xULN
16. Billirubin ≤ 3x ULN
17. Albumin ≥ 25 g/L
18. Serum/plasma creatinine ≤1.5 x ULN or creatinine clearance ≥50 mL/min based on Cockcroft-Gault formula.
19. Received at least one ARAT in the past.
20. Patients on anti-androgen therapy are allowed to continue their treatment at the descretion of their oncologists.

Exclusion Criteria:

1. Less than 6 weeks since last myelosuppressive therapy (including Docetaxel, Cabazitaxel, 223Ra, 153Sm, 177Lu-PSMA-617, 177Lu-PSMA-I&T) or other radionuclide therapy permitted (including 223Ra, 153Sm).
2. Urinary tract obstruction as evidenced by Tc-99m DTPA renal scan with diuretics.
3. Abnormal renal function (eGFR < 60 mL/min), baseline Hgb < 9g/dL, ANC< 1.5 x 10⁹/L, platelets < 100 x 10⁹/L, and PT, INR or PTT ≥1.5xULN.
4. Persistent baseline dry eye or dry mouth from prior RLT.
5. Persistent prior AEs > Grade 1 from prior anti-cancer therapies
6. Administration of an investigational agent ≤60 days or 5 half-lives, whichever is shorter, prior to randomization.
7. Known presence of central nervous system metastases.
8. Active malignancy other than low-grade non-muscle-invasive bladder cancer andnon-melanoma skin cancer.
9. Concurrent illness that may jeopardize the patient’s ability to undergo study procedures.
10. Symptomatic cord compression, or clinical or radiologic findings indicative of impending cordcompression.
11. Concurrent serious (as determined by the investigator) medical conditions, including, but not limited to, New York Heart Association class III or IV congestive heart failure (see 12.1Appendix 1), unstable ischemia, uncontrolled symptomatic arrhythmia, history of congenitalprolonged QT syndrome, uncontrolled infection, known active hepatitis B or C, or othersignificant co-morbid conditions that in the opinion of the investigator would impair studyparticipation or cooperation.
12. Major surgery ≤30 days prior to randomization.
13. Planning to conceive pregnancy during the treatment and up to 6 month after the last treatment.

Please fax or email the information to:

Mrs. Susan Cork
Therapy Coordinator
Excel Diagnostics and Nuclear Oncology Center
Scork@ExcelDiagnostics.com or 713-781-6206 (fax)

LEARN ABOUT PROSTATE CANCER:

American Cancer Society: https://www.cancer.org/cancer/prostate-cancer.html

Urology Care Foundation: https://www.urologyhealth.org/urologic-conditions/prostate-cancer

Healthline for prostate cancer: https://www.healthline.com/health/prostate-cancer

RITA's Sponsored Treatments for Neuroendocrine Cancers

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Participation & Outcomes

More than 100 patients have been treated with high activity In-111 Octreotide with outcomes superior to conventional chemotherapy or cold Sandostatin. Therapy with lu-177 Octreotate was approved by FDA on August 18, 2010, and more than 20 patients have already enrolled and received treatment.

Patient Recruitment & Eligibility

Recruitment of patients is continued on both treatments. Please submit the following clinical and laboratory information if you would like to be evaluated for eligibility to receive Peptide Receptor Radionuclide Therapy (PRRT) for Neuroendocrine cancer:

1. Pathology report from initial biopsy or surgery.
2. Result of most recent Octreoscan.
3. Recent reports of diagnostic imaging studies including CT scans, MRI, PET scans
4. Most recent History and Physical report by your primary oncologists.
5. Recent treatments and medications.

Please fax or email the information to:

Mrs. Susan Cork
Therapy Coordinator
Excel Diagnostics and Nuclear Oncology Center
Scork@ExcelDiagnostics.com or 713-781-6206 (fax)

Neuroendocrine Tumors Overview

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Neuroendocrine tumors (NETs) are a heterogeneous group of neoplasms that arise from Kulchinsky cells that populate the thymus, bronchus and gut. Regardless of their primary site, NETs share similar histological, metabolic and ultrastructural features 1. Many NETs are found during surgery for other diagnoses, such as appendicitis, pancreatitis or small bowel obstruction. The average time from symptom onset to diagnosis is sometimes more than 9 years 2. The indolent nature of NETs lead most patients seek treatment for their tumor when it has already metastasized limiting their overall survival 3. Therapeutic options for patients with advanced disease are often limited. Single agent or combination chemotherapy regimens for management of "typical" slow growing NETs have not been efficacious. Furthermore, external-beam radiation therapy has not demonstrated significant efficacy in establishing local control in NETs. Interferon (IFN) therapy has also been used in protocol-based management of Carcinoid tumors with reported biochemical and tumor response rates of 40% and 12% respectively 4, 5. However, IFN therapy is associated with numerous toxicities including fever, anorexia, weight loss, fatigue and myelosuppression. Due to the high incidence of toxicity and the low tumor response rate, the routine use of IFN for NETs is rarely recommended in the USA.

Peptide Receptor Radionuclide Therapy (PRRT)

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PRRT is a therapeutic approach that uses the affinity of special peptide (small protein) called Octreotide for targeting the NET tumor cells. When this peptide is attached to radioactive materials such as Indium-111, Lu-177 or Y-90, it can deliver significant amount of radiation specifically to tumor cells (Targeted Therapy). While medication is administered systemically, the radioactive peptide only resides at the site of the tumor cells, wherever they exist in the body, and washes out rapidly from the normal organs. Therefore, the therapeutic effect of radioactive material will occur in the region of the tumors with minimal and reversible effects on the normal tissue. This is the reason for typically mild side effects secondary to this treatment approach when is compared with systemic chemotherapy.

High Activity Indium-111 Octreotide Therapy

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Indium-111 Octreotide is a radioactive labeled peptide (small protein) that has affinity for Somatostatin receptors which exist almost exclusively on the cell surface of Neuroendocrine cancer cells. This agent in low dose (about 5.0 mCi) is used as a diagnostic imaging test to identify the locations of the Neuroendocrine tumors. Significantly higher doses such as 500 mCi of this agent has been shown to have therapeutic effects on these tumors.

Excel Diagnostics and Nuclear Oncology Center in collaboration with RITA Foundation, Baylor College of Medicine, and St. Luke's Hospital started treating patients with this agent in August of 2005. The treatment was under FDA oversight and approved Investigational New Drug Application. The result of our treatments on first 32 patients with at least 2 cycles of treatment with 500 mCi In-111 Octreotide was very promising and was published in Cancer Biotherapy and Radiopharmaceuticals in 2008. As of May of 2010 more than 100 patients have received up to 4 cycles of this treatment with majority of the patients with previous progressive disease achieving stable disease and significant improvement in their clinical symptoms. Our scientist are in the final stage of collecting the data on these patients which will be ready for publication in early 2011. For further information about this treatment and Insurance coverage for this therapy please contact Ms. Susan Cork at: Scork@ExcelDiagnostics.com.

Lutetium-177 Octreotate Therapy

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Lutetium -177 Octreotate is another somatostatin receptor seeking agent that can detect neuroendocrine tumor cells throughout the body, attach to them and delivers therapeutic dose of radioactivity to the tumor. This targeted radionuclide therapy has shown significant therapeutic effect on previously progressive tumors. Following is the results of the treatment on several hundred patients performed at Erasmus Medical Center in Netherlands:

"From January 2000 until August 2006 1772 treatments with lutetium-octreotate were given to a sum of 504 patients. Most patients had neuroendocrine tumours. A preliminary analysis in 310 patients with so-called gastroenteropancreatic tumours was performed after obtaining all results after finishing the treatment. This showed a decrease in the size of the tumours in 46% of patients, stable disease in 35% and progression of the tumour despite treatment in 20%. A significant improvement of quality of life in those patients with tumour regression was also noted. The average duration of the effect of therapy was 40 months, calculated from the start of therapy. In addition, there are strong indications that patients treated with Lutetium-octreotate, on average, survive several years longer (3-6 years) than patients who did not get this treatment. "

Other centers in Europe including Germany, Switzerland, Italy, Sweden and others have also reported very promising results on the effectiveness and safety of this treatment option.

We at Excel Diagnostics and Nuclear Oncology Center are pleased to announce that we will have this treatment available for our patients in the United States in mid October of 2010. Please refer to our press release on August 18, 2010 regarding this exciting news.

Following is some information for our patients regarding this treatment at our center:

Our protocol calls for 4 treatments every 6-9 weeks. For the first therapy, patients should expect staying 2 weeks in Houston. For the subsequent therapies, only one week. During their stay in Houston, patients will undergo all the protocol required imaging studies. We have to repeat the Octreoscan even patient has done it recently, since we have to do dosimetry with the study. A list of these studies will be sent to the referring physicians prior to the patient arrival in Houston. Lab request will be sent to the patients by our office, so they can do them before coming to Houston.

There are low cost but safe and clean facilities within one mile from our center that are currently housing our Indium therapy patients. Average cost per night is around $ 75.00 per night.

1. We will need the following information to start the evaluation and registration:
2. Patient demographics including patient contact and Insurance information.
3. Pathology report of biopsy or surgical specimen.
4. Recent Radiology imaging study reports.
5. Recent Octreoscan report and preferably CD (Within one year is fine)
6. Recent H&P including patient's current medications.
7. Recent labs including any marker studies.

We will have a brochure with all the necessary information ready for the patients and referring physicians in September of 2010. Please contact Excel clinical coordinators Susan Cork Scork@exceldiagnostics.com for further information and registration for this therapy.