Phase I Study of Intensity Modulated Radiation Therapy for Prostate Cancer

NCT00124917 | Terminated Phase 1 Results

• 2 other identifiers: 05019105-C-0191
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

BACKGROUND:

• This study represents a progression from findings in four previous National Cancer Institute (NCI) Radiation Oncology Branch (ROB) protocols (02-C-0167A, 02-C-0207E, 03-C-0190B, 04-C-0171). In these previous works we have begun to develop techniques to obtain magnetic resonance (MR) biological images and co-register tissue in prostate cancer patients. OBJECTIVES:
• The scientific objective of this protocol is to determine the maximum tolerated dose (MTD) of external beam radiation to regions of interest within the prostate based acute toxicity. Secondary objectives of this study are to relate patterns in gene and protein expression to response and toxicity and to evaluate the frequency of late term toxicity. ELIGIBILITY:
• Patients with prostate cancer without evidence of metastasis will be eligible for this study. DESIGN:
• This phase I trial will use intensity modulated radiation therapy (IMRT) to deliver escalating doses of external beam radiation to regions of histologically confirmed prostate cancer. The study will be conducted using a standard 3-6 dose-escalation with an initial 3 patients in each dose cohort and the potential expansion of the cohort to 6 patients.
• Anatomic magnetic resonance imaging (MRI) and magnetic resonance (MR) biological images, such as magnetic resonance spectroscopy (MRS), will be obtained. Tissue will be acquired from sites of interest, with biopsy locations precisely translated (co-registered) to an MR image of reference. Tissue samples will be processed for complementary deoxyribonucleic acid (cDNA) microarray testing and stored for future analysis in the Radiation Oncology Branch, NCI. A gold seed will be left at the biopsy site as a fiducial marker to direct future radiation therapy. If necessary, additional fiducial markers will be placed for target localization during treatment.
• Once MR guided biopsies are obtained and fiducial markers placed, the patient will undergo a standard computed tomography (CT) simulation for radiation therapy treatment planning. The MR and CT images will be fused. Areas of pathologically confirmed malignancy will undergo dose escalation as described below. Areas of image abnormality that could not be biopsied or were without definite pathologic evidence of malignancy will be given intermediate doses. The remainder of the prostate gland will receive standard dose (7560 centigray (cGy)').
• The trial will accrue 18 to 36 patients with an anticipated accrual period of 2 years.

Conditions

Prostate Cancer

Keywords

Prostate Cancer; MRI; Fiducial Marker; IMRT

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose (MTD) of External Beam Radiation

  Maximum tolerated dose is defined as the dose level immediately below the dose level at which 2 or more in a cohort of either 3 or 6 patients experienced a dose limiting toxicity attributed to radiation therapy.

  12 weeks after radiation therapy (RT)

Secondary Outcomes (1)

• Number of Participants With Serious and Non-serious Adverse Events

  53 months and 20 days

Other Outcomes (3)

• Radiation Response With Genomic and Proteomic Analyses

  completion of therapy

• Correlate Toxicity With Genomic and Proteomic Analyses

  Completion of therapy

• Long-term Effects and Toxicity Following Selective Intra-prostatic Dose Escalation

  completion of therapy

Study Arms (1)

Radiation Therapy

EXPERIMENTAL

Radiation to tumor area as per protocol

Radiation: Radiation

Interventions

Radiation RADIATION

Areas of pathologically confirmed malignancy will undergo dose escalation as described below. Areas of image abnormality that could not be biopsied or were without definite pathologic evidence of malignancy will be given intermediate doses. The remainder of the prostate gland will receive standard dose (as per the Radiation Therapy Oncology Group (RTOG) 9406 study) 7560 centigray (cGy) in 180 cGy daily fractions.\[1\]

Radiation Therapy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
• Pathology report confirming adenocarcinoma of the prostate
• Risk of lymph node metastasis less than 10% as defined by the Partin tables
• Tumor visible on magnetic resonance imaging (MRI)
• No prior surgery, radiation, or chemotherapy for prostate cancer.
• Age greater than 18 y/o and less than 90 years old.

You may not qualify if:

• Cognitively impaired patients who cannot give informed consent.
• Patients with metastatic disease.
• Contraindication to biopsy
• Bleeding disorder
• Prothrombin time (PT)/Partial Thromboplastin Time (PTT) greater than or equal to 1.5 times the upper limit of normal
• Platelets less than or equal to 50K
• Artificial heart valve
• Contraindication to magnetic resonance imaging (MRI)
• Patients weighing greater than 136 kgs (weight limit for the scanner tables)
• Allergy to MR contrast agent
• Patients with pacemakers, cerebral aneurysm clips, shrapnel injury or implantable electronic devices.
• Pre-existing and active prostatitis or proctitis
• Other medical conditions deemed by the principal investigator (PI) or associates to make the patient ineligible for protocol investigations, procedures, and high-dose external beam radiotherapy.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Michalski JM, Winter K, Purdy JA, Perez CA, Ryu JK, Parliament MB, Valicenti RK, Roach M 3rd, Sandler HM, Markoe AM, Cox JD. Toxicity after three-dimensional radiotherapy for prostate cancer with RTOG 9406 dose level IV. Int J Radiat Oncol Biol Phys. 2004 Mar 1;58(3):735-42. doi: 10.1016/S0360-3016(03)01578-5.

  PMID: 14967428 BACKGROUND

• Pollack A, Zagars GK, Starkschall G, Antolak JA, Lee JJ, Huang E, von Eschenbach AC, Kuban DA, Rosen I. Prostate cancer radiation dose response: results of the M. D. Anderson phase III randomized trial. Int J Radiat Oncol Biol Phys. 2002 Aug 1;53(5):1097-105. doi: 10.1016/s0360-3016(02)02829-8.

  PMID: 12128107 BACKGROUND

• Pollack A, Hanlon A, Horwitz EM, Feigenberg S, Uzzo RG, Price RA. Radiation therapy dose escalation for prostate cancer: a rationale for IMRT. World J Urol. 2003 Sep;21(4):200-8. doi: 10.1007/s00345-003-0356-x. Epub 2003 Sep 5.

  PMID: 12961097 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiation

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)

Physical Phenomena

Results Point of Contact

• Title: Dr. Deborah Citrin
• Organization: National Cancer Institute

Debra_Citrin@nih.gov

301-496-5457

Study Officials

• Aradhana Kaushal, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 27, 2005
• First Posted: July 28, 2005
• Study Start: July 21, 2005
• Primary Completion: March 6, 2011
• Study Completion: May 9, 2017
• Last Updated: September 13, 2019
• Results First Posted: September 13, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)