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A Feasibility Trail of Proton Radiation Therapy or Intensity Modulated Radiation Therapy (IMRT) Using Mild Hypofractionation for Intermediate -Risk Adenocarcinoma of the Prostate


N/A
18 Years
N/A
Open (Enrolling)
Male
Prostate Adenocarcinoma

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Trial Information

A Feasibility Trail of Proton Radiation Therapy or Intensity Modulated Radiation Therapy (IMRT) Using Mild Hypofractionation for Intermediate -Risk Adenocarcinoma of the Prostate


This study will be done in two phases, first, a feasibility study and then a registration
study. In the first, feasibility will be established using the primary objectives set
below. The second phase will begin no earlier than 30 days after the last patient in the
initial phase has completed treatment and once safety and feasibility has been verified.
The secondary objectives will serve as the objectives for the second phase of the study.


Inclusion Criteria:



- Histoloically confirmed prostate adenocarcinoma within 365 days of registration.

- Clinical stages T1a-T2c N0 M0 (AJCC Criteria 6th Ed). For any pelvic lymph node > 1.5
cm, biopsy of the lymph node is mandatory.

- Histological evaluation of prostate biopsy with assignment of a Gleason score to the
biopsy material; Gleason score must be in the range 2-7. Biopsy with >6 cores is
strongly recommended. (The highest Gleason Score in any core reported on the
pathology report will be used for determining inclusion.)

- PSA values < 20ng/ml within 90 days prior to registration, and done either prior to
prostate biopsy, or at least 21 days after prostate biopsy. If Gleason score is < 6,
PSA value should be < 10 ng/ml.

- Zubrod status 0-1 documented within 60 days of registration.

- Androgen deprivation is at the discretion of the treating radiation oncologist.

- Patients must give IRB approved study specific informed consent.

- Patients must complete all required tests (History/Physical exam, Zubrod performance
status, CBC, PSA, CT or MRI, Transrectal ultrasound with prostate core
biopsies/Histological evaluation, Transrectal prostate fiducial marker placement,
Bone scan, Bone x-ray or CT (if bone scan is equivocal), EPIC, EQ-5D, IPSS QOL
instruments, Kilovoltage images, x-rays, fluoroscopy, 4D CT-scan, Prostate
ultrasound, MRI diffusion, Calypso localization and tracking, Directed prostate
biopsy, Local Pathology review, Physics consultation, Follow-Up Phone Call)

- Patients must be able to start treatment within 56 days of registration.

- Patients must be at least 18 years old.

- Members of all races and ethnic groups are eligible for this trial.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Number of Participants with Adverse Events

Outcome Description:

Unable to tolerate 10% of treatments using proton radiotherapy. Unable to complete all treatments. Cannot be given treatment because anatomy is such that a dosimetrically satisfactory treatment plan cannot be devised.

Outcome Time Frame:

Within 10 days

Safety Issue:

Yes

Principal Investigator

Neha Vapiwala, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Abramson Cancer Center of the University of Pennsylvania

Authority:

United States: Institutional Review Board

Study ID:

UPCC 18809

NCT ID:

NCT01352429

Start Date:

August 2009

Completion Date:

August 2014

Related Keywords:

  • Prostate Adenocarcinoma
  • adult
  • histologically confirmed
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Prostatic Neoplasms

Name

Location

Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283