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A Phase I Dose-Escalation Study of Preoperative Radiation Therapy Followed by Radical Prostatectomy in Patients With High-Risk, Localized Carcinoma of the Prostate


Phase 1
N/A
69 Years
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

A Phase I Dose-Escalation Study of Preoperative Radiation Therapy Followed by Radical Prostatectomy in Patients With High-Risk, Localized Carcinoma of the Prostate


Patients in Groups 1 and 2 will receive 39.6 Gy and 45 Gy (at 1.8 Gy/fraction),
respectively, to the whole pelvis. Patients in Groups 3 and 4 will receive 45 Gy to the
whole pelvis, followed by a boost to the prostate and periprostatic tissue, for total doses
of 50.4 and 54 Gy, respectively. The patients will then undergo radical prostatectomy
between 4-8 weeks after completion of radiation.


Inclusion Criteria:



- Subjects must have biopsy-confirmed adenocarcinoma of the prostate.

- Subjects must have a negative bone scan.

- Subjects must have "high-risk" prostate cancer, defined as:

A. PSA >/= 20, and/or B. Gleason Score (GS) >/= 8, and/or C. Clinical stage T3 disease per
AJCC Staging Manual, 6th edition; or D. At least two out of three of the following: PSA
10-19.9, GS = 7, or clinical stage = T2b / T2c.

- Subjects must be medically fit to undergo surgery as determined by treating
urologist.

- Subjects must be under 70 years of age.

- KPS must be >/= 80.

- Subjects must not have a synchronous primary tumor, or a previous cancer unless
disease free for >/= 5 years.

- Subjects must not have had prior pelvic radiation therapy, chemotherapy, or androgen
deprivation.

- Subjects must freely sign informed consent to enroll in the study.

Exclusion Criteria:

- Metastatic disease as demonstrated by bone scan, CT scan or MRI of the pelvis, or
chest x-ray.

- Pathologically documented positive pelvic lymph nodes. If Pre-operative CT scan or
MRI (ordered at the discretion of the treating physicians) demonstrates lymph nodes
which are suspicious for involvement, then biopsy must be undertaken and nodes proven
negative before patient can enroll on this trial.

- Declared high-risk for anesthesia by attending anesthesiologist, cardiologist, or
other physician.

- History of prior pelvic radiation therapy.

- History of androgen deprivation therapy or chemotherapy.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Evaluate number of patients who are able to undergo surgery after preoperative radiation therapy.

Outcome Time Frame:

4 months

Safety Issue:

Yes

Principal Investigator

Mitchell S. Anscher, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Virginia Commonwealth University

Authority:

United States: Institutional Review Board

Study ID:

Duke-10571

NCT ID:

NCT00691977

Start Date:

September 2007

Completion Date:

December 2009

Related Keywords:

  • Prostate Cancer
  • Radiation Therapy
  • Carcinoma
  • Prostatic Neoplasms

Name

Location

Virginia Commonwealth UniversityRichmond, Virginia