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Stereotactic Body Radiation Therapy and Short-Term Androgen Ablation for Intermediate-Risk, Localized, Adenocarcinoma of the Prostate

Phase 1/Phase 2
18 Years
Not Enrolling
Adenocarcinoma of the Prostate

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Trial Information

Stereotactic Body Radiation Therapy and Short-Term Androgen Ablation for Intermediate-Risk, Localized, Adenocarcinoma of the Prostate

This will be a Phase I/II study evaluating the effectiveness and toxicity of a combined
regimen of 7.25 Gy every other day fractions to a total dose of 36.25 Gy (total of 5
fractions) with androgen deprivation therapy (ADT) for 4 months total, 2 months before and 2
months after the hypofractionated radiation delivered.

Inclusion Criteria:

- Histologically confirmed, locally confined adenocarcinoma of the prostate

- Clinical stages T1a-T2c

- PSA of less than 20 ng/ml

- Gleason score of less than 8

- Patient must fit D'Amico intermediate risk criteria by clinical stage (T2b-T2c), PSA
(prostatic specific antigen) (10-20 ng/mL), and/or Gleason score (Gleason 7).

- The patient has decided to undergo external beam radiation as treatment choice for
his prostate cancer.

- Signed study-specific consent form prior to registration

Exclusion Criteria:

- Stage T3-4 disease.

- Gleason 8 or higher score.

- PSA > 20 ng/ml.

- IPSS (International Prostate Symptom Score) > 15

- Clinical or Pathological Lymph node involvement (N1).

- Evidence of distant metastases (M1).

- Radical surgery for carcinoma of the prostate.

- Previous Chemotherapy or pelvic radiation therapy.

- Previous or concurrent cancers other than basal or squamous cell skin cancers or
superficial bladder cancer unless disease free for at least 5 years.

- History of inflammatory bowel disease.

- Major medical or psychiatric illness which, in the investigator's opinion, would
prevent completion of treatment and would interfere with follow up.

- Myocardial infarction or cerebrovascular accident within one year from consultation,
or other major vascular risk factor which would prevent a patient from receiving
appropriate androgen deprivation therapy.11

- Liver function tests (LFTs) greater than twice the upper limit of normal.

Type of Study:


Study Design:

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

Outcome Measure:

Toxicity Assessment

Outcome Description:

1) Assess the incidence of grade 3 or greater GU (genitourinary) and GI (gastrointestinal) toxicity with image-guided radiation therapy in doses of 7.25 Gy every other day to a total dose of 36.25 Gy (5 fractions) along with 4 months of androgen deprivation therapy (ADT) neoadjuvantly and concurrently.

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Phuoc Tran, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Johns Hopkins University School of Medicine


United States: Food and Drug Administration

Study ID:




Start Date:

April 2013

Completion Date:

March 2015

Related Keywords:

  • Adenocarcinoma of the Prostate
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Prostatic Neoplasms



The Sidney Kimmel Comprehsive Cancer Center at Johns HopkinsBaltimore, Maryland  21231