Overview

This trial is active, not recruiting.

Condition prostate cancer
Treatment radiation therapy
Phase phase 2
Sponsor University of Michigan Cancer Center
Collaborator Fox Chase Cancer Center
Start date January 2011
End date June 2017
Trial size 68 participants
Trial identifier NCT01288534, 2010.064, HUM00041474

Summary

The purpose of this study is to evaluate the safety and tolerability of using radiation therapy with 5 fractions of radiation to treat prostate cancer with guidance of radiation using the Calypso 4D Treatment System (Calypso).A number of recent studies have used 5 radiation fraction to treat prostate cancer over 2-3 weeks as compared to the typical treatment which would involve 40-42 smaller radiation fractions over 8-9 weeks. This type of radiation using a smaller number of treatments has been called hypofractionated radiation therapy.

The Calypso is a new technique which uses beacons implanted into the prostate which using radio signals are able to localize and track the position of the prostate continuously during radiation therapy. The Calypso system has been approved by the United States Food and Drug Administration (FDA) for guidance of radiation therapy during the treatment of prostate cancer and is being utilized all across the United States. However, it has not been tested for hypofractionated radiation therapy.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
radiation therapy
Patients will receive 5 fractions of radiation (you will not receive radiation therapy on two consecutive days). Each fraction size will be 7.4 Gy. The total dose will be 37 Gy. The 5 treatments will be scheduled to be delivered 2 fractions per business week (Monday through Friday). The total duration of treatment will be no shorter than 15 days and no longer than 19 days.

Primary Outcomes

Measure
Evaluate the safety of the proposed hyperfractionation regimen
time frame: 5 years

Secondary Outcomes

Measure
To evaluate clinical outcomes including clinical recurrence
time frame: 5 years
To look at the relation between dose distribution and toxicities.
time frame: 5 years
To determine the relation between reconstructed delivered dose distributions.
time frame: 5 years
To assess the frequency of required interventions.
time frame: 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - 18 years of age or older - Histologically confirmed diagnosis of adenocarcinoma of the prostate within 180 days of enrollment - Signed informed consent - Gleason score ≤ 7 - If Gleason 7 (3+4=7 or 4+3=7) then <50% of biopsy cores must be positive for any pathologic grade of prostate cancer - If Gleason score <7 then there is no limit on the percentage of biopsy cores involved by prostate cancer - PSA (within 90 days prior to enrollment) - ≤ 15 ng/ml prior to start of therapy if Gleason ≤ 6 and - ≤ 10 ng/ml prior to start of therapy if Gleason 7 - No plan to use hormone therapy prior to evidence of biochemical failure(ie: No neoadjuvant or adjuvant ADT) - Tumor stage: T1a, T1b, T1c, T2a, T2b - ECOG Performance Status 0-1 Exclusion Criteria: - A history of other malignancy diagnosed within the previous 60 months except for non-melanoma skin cancer. - Any patients who have received other investigational therapy within the last 60 days - Individuals that have previously been implanted with permanent Beacon transponders - Patients that have any prosthetic implants in the pelvic region that contain metal or conductive materials (e.g., an artificial hip) - Patients with implanted pacemaker or defibrillators - Patients who are felt to have body habitus not conducive to tracking with Calypso beacons - Positive lymph nodes or metastatic disease from prostate cancer - Tumor stage: T2c, T3, or T4 - Previous pelvic radiation therapy - Previous surgery or chemotherapy for prostate cancer - Previous transuretheral resection of the prostate (TURP) or cryotherapy to the prostate - Prior hormone therapy or plans for concurrent or post treatment adjuvant hormonal therapy or chemotherapy - Hormone therapy to include LHRH agonist or oral anti-androgen - Finasteride and Dutasteride use not excluded - Concomitant antineoplastic therapy (including surgery, cryotherapy, conventionally fractionated radiation therapy, and chemotherapy) while on this protocol - History of Crohn's Disease or Ulcerative Colitis

Additional Information

Official title A Study of Hypofractionated Stereotactic Body Radiation Therapy (SBRT) Using Continuous Real-time Evaluation of Prostate Motion
Principal investigator Daniel Hamstra, Ph.D., MD
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by University of Michigan Cancer Center.