Defining Recurrent Disease With Axumin™

NCT03996993 | Unknown FDA Drug

• 1 other identifier: 2018/12/7
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This project seeks to use advanced imaging (specifically, positron emission tomography/computed tomography \[PET/CT\]) to detect, locate, and characterize recurrent disease in the setting of patients with prostate cancer.

Conditions

Prostate Cancer; Prostate Adenocarcinoma

Keywords

prostate cancer; Axumin

Outcome Measures

Primary Outcomes (1)

• Percentage of baseline Axumin uptake

  Utilizing standard uptake values (SUV) from the tumor origin, serial Axumin SUV values will be calculated as a percentage of the baseline SUV value.

  2019-2020

Secondary Outcomes (1)

• PSA blood draw

  2019-2020

Study Arms (2)

Hormone Therapy Cohort

Post-radical prostatectomy patients fitting our inclusion criteria, including rising PSA \> 0.1 ng/ml, a positive SOC Axumin scan, and a patients not having received hormonal therapy for a minimum of 3 months, will receive hormonal therapy in the form of Casodex for 2 weeks, followed by Lupron indefinitely. Patients will then receive serial Axumin scans up to 1 year post-therapy.

Drug: Casodex, Axumin

Salvage Radiotherapy Cohort

Post-radical prostatectomy patients fitting our inclusion criteria, including rising PSA \> 0.1 ng/ml, not concurrently on androgen deprivation therapy (ADT) and/or received ADT in the past 3 months, and a positive SOC Axumin scan, will receive salvage radiation therapy according to the following protocol. External beam radiation therapy will be delivered in the form of high-dose intensity modulated radiation therapy (IMRT). A total prescribed dose of 72 Gy will be delivered in 40 fractions over 8 weeks. For the first 25 fractions, the clinical target volume (CTV) is defined as the residual prostatic bed, plus internal/external iliac nodes. For the subsequent 15 fractions the CTV is defined as the residual prostatic bed plus margin. As part of SOC, the radiation fields will incorporate the Axumin positive areas into treatment planning objectives. Patients will then receive serial Axumin scans up to 1 year post-therapy.

Radiation: Salvage Radiation, Axumin

Interventions

Casodex, Axumin DRUG

Patients will receive hormone therapy if Axumin positive area appears.

Also known as: Lupron

Hormone Therapy Cohort

Salvage Radiation, Axumin RADIATION

Patients will receive salvage radiation therapy if Axumin positive area appears.

Salvage Radiotherapy Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men with recurrent prostate cancer.

You may qualify if:

• General requirements:
• Karnofsky performance status of \>50 (or ECOG/WHO equivalent).
• Age \> 18.
• Ability to understand a written informed consent document, and the willingness to sign it.
• History of histologically confirmed adenocarcinoma of the prostate and underwent radical prostatectomy for primary treatment with curative intent.
• Men diagnosed with recurrent/persistent prostate cancer disease following radical prostatectomy based on a detectable or rising PSA value ≥ 0.1 ng/ml.
• Positive commercial standard of care (SOC) Axumin scan at time of restaging disease.
• Patients should not have been previously treated for biochemical recurrence (BCR) (i.e., this is the first diagnosis for BCR.
• Language proficiency in English, Spanish, Japanese, Korean, Vietnamese. Our office has translators to coherently translate the consent documents to patients.
• Ability to tolerate androgen deprivation therapy (Casodex and Lupron) indefinitely.
• Been off ADT for minimum of 3 months.
• Ability to receive a possible of 4 Axumin PET/CT scans within a year.
• Considering salvage radiotherapy.
• Ability to tolerate salvage radiation therapy for 8 weeks.

You may not qualify if:

• General requirements:
• Patients not capable of getting PET study due to weight, claustrophobia, allergic reaction, and/or inability to lay still for the duration of the exam.
• Women and children.
• Men currently on or seeking primary treatment (surgery or radiation) for prostate cancer.
• History of bilateral orchidectomy.
• Neoadjuvant chemotherapy or radiation therapy prior to prostatectomy. This includes focal ablation techniques (HiFu).
• Ongoing treatment with any systemic therapy intended for the treatment of prostate cancer (e.g., antiandrogen or LHRH agonist or antagonist).
• Prior history of any other malignancy within the last 2 years, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer.
• Being considered for salvage radiotherapy.
• Androgen deprivation therapy (ADT) in the past 3 months.
• \. Currently on ADT or on ADT within the past 3 months.

Sponsors & Collaborators

• Cancer Center of Irvine: lead

Study Sites (1)

Kenneth Tokita

Irvine, California, 92619, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

bicalutamide; fluciclovine F-18; Leuprolide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2019
• First Posted: June 25, 2019
• Study Start: July 1, 2019
• Primary Completion: September 30, 2020
• Study Completion: December 30, 2020
• Last Updated: June 25, 2019

Record last verified: 2019-06

Locations

US (1)