PET Acetate for Castrate-Resistant Prostate Cancer on Chemotherapy

NCT01144897 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 201002720
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

One purpose of this research study is to examine if a special type of imaging test, a positron emission tomography (PET) scan using the radioactive material \[C-11\] acetate, will be helpful in detecting prostate cancer lesions in subjects with castrate-resistant prostate cancer (CRPC). This PET scan will be combined with a computed tomography (CT) scan taken during the same imaging session. The other purpose of the PET-CT scan using \[C-11\] acetate (PET Acetate Scan) is to assist in identifying who is responding to the treatment (docetaxel chemotherapy).

Conditions

Castrate Resistant Prostate Cancer; Prostate Cancer

Keywords

Castrate resistant; Prostate cancer; Docetaxel; Taxotere; PET Acetate

Outcome Measures

Primary Outcomes (1)

• Interpretation of PET Acetate scans

  Standardized uptake values (mean and maximum SUVs) will be determined over the prostate bed and over any acetate-avid or CT-identified suspicious lesions. The change in these SUVs with treatment will be assessed, as well as the number of lesions. A blinded second reviewer from Nuclear Medicine will reviewed all baseline and response PET-acetate scans.

  Time of enrollment up to one year

Secondary Outcomes (1)

• Prostate cancer response to treatment and progression (excluding PET Acetate assessment)

  Time of enrollment up to two years

Study Arms (1)

PET Acetate Imaging with Docetaxel

EXPERIMENTAL

PET-acetate as an intermediate endpoint in the assessment of response of patients undergoing docetaxel for hormone refractory prostate cancer (HRPC). Subjects will be treated with docetaxel, 75 mg/m2 every 21 days until disease progression or unacceptable toxicity occurs. Subjects will have two PET acetate scans - one prior to beginning chemotherapy and one approximately 8-9 weeks after chemotherapy has begun.

Radiation: PET Acetate scan; Drug: Carbon-11 labeled Acetate

Interventions

PET Acetate scan RADIATION

PET Acetate scans will be done to detect prostate cancer lesions.

PET Acetate Imaging with Docetaxel

Carbon-11 labeled Acetate DRUG

C-11 Acetate is a radiotracer used in PET scanning

Also known as: C-11 Acetate; Acetate

PET Acetate Imaging with Docetaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to understand and willingness to sign a written consent document.
• Patients must have histologically documented adenocarcinoma of the prostate at any time in the past.
• At the time of enrollment: Patients must have evidence of castrate resistant metastatic prostate cancer (patients with rising PSA only and no other radiographic evidence of metastatic prostate cancer are not eligible). In addition, progressive disease is required as per #5 below.
• Two categories of eligible patients exist: Measurable disease with any level of serum prostate-specific antigen (PSA) OR Non-measurable disease (positive bone scan) with PSA equal or greater than 2 ng/ml
• Definition of Measurable Disease/Target Lesions - Any lesion \>/= 1 cm on spiral computed tomography (CT) that is believed to represent metastatic prostate cancer and that can be accurately measured in at least one dimension (longest diameter). However, if the lesion is a lymph node, it needs to be equal or greater than 20 mm (longest diameter) based on CT scans or physical exam (palpable lymph nodes). Chest X-ray with clearly defined lung lesions surrounded by aerated lung or parenchymal lung lesions measured as 10 mm or greater with a spiral CT are also eligible.
• Definition of Non-measurable Disease/Non-target Lesions - Non-target lesions include all other lesions not included above, including bone lesions. Previously irradiated lesions should not be used for eligibility unless progression was documented after radiation therapy.
• In order to be eligible, patients must have demonstrated evidence of progressive disease prior to enrollment. Progressive disease is defined as any one of the following:
• Measurable Disease Progression: Objective evidence of increase 20% or more in the sum of the longest diameters (LD) of target lesions from the time of maximal regression after prior therapy; or the appearance of one or more new lesions.
• Bone Scan Progression: Appearance of two or more new lesions on bone scan. If no prior bone scan exists, presence of 2 lesions is needed for eligibility.
• PSA Progression: An elevated PSA (2 ng/mL or higher) which has risen serially on at least two occasions at least each 1 week apart. Note: If patient was on antiandrogens as last therapy, 6 weeks need to elapse after discontinuation of the antiandrogen. For prior ketoconazole, 4 weeks need to elapse. If the confirmatory PSA (#2) value is less than the first rising PSA value, then an additional rising PSA (#3) will be required to document progression. For the purposes of this study, the last PSA value recorded prior to the initiation of treatment will be considered the baseline PSA.
• Progression despite standard androgen deprivation therapy.
• At least 4 weeks since any systemic steroids (any dose; unless used chronically for another illness at equal or less than 10 mg of prednisone daily, or in conjunction with prior ketoconazole resulting in slow steroid taper) and any other hormonal therapy.
• No prior cytotoxic chemotherapy for prostate cancer.
• Four weeks or longer since major surgery and fully recovered.
• Four weeks or longer since any prior radiation (including palliative) and fully recovered.

You may not qualify if:

• No known brain metastases (brain imaging MRI/CT is not required unless clinical symptoms).
• No current congestive heart failure (New York Heart Association Class III or IV).
• No serious or non-healing wound, ulcer or bone fracture.
• No peripheral neuropathy ≥ grade 2.
• Patients with known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies are not eligible.
• Patients who received prior docetaxel for any reason are not eligible.
• PC-Spes, Saw Palmetto, and St. John's Wort must be discontinued before registration. The discontinuation of other herbal medications and food supplements is strongly encouraged. Patients may continue on daily vitamins and calcium supplements.
• No known allergy to acetate.
• No severe claustrophobia
• Concurrent use of statins is allowed on study but use should not have started 30 days prior to entry into the study

Sponsors & Collaborators

• Daniel Vaena: lead

Study Sites (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

carbon-11 acetate

Condition Hierarchy (Ancestors)

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

Study Officials

• Daniel Vaena, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 14, 2010
• First Posted: June 16, 2010
• Study Start: May 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: September 1, 2018
• Last Updated: October 2, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)