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Radiation and Androgen Ablation for Prostate Cancer

This study is not yet open for participant recruitment.
Verified February 2013 by Sidney Kimmel Comprehensive Cancer Center
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01517451
First received: January 20, 2012
Last updated: February 12, 2013
Last verified: February 2013
History of Changes
  Purpose

A study to see how effective and tolerable radiation therapy along with androgen suppression therapy is in treating prostate cancer.


Condition Intervention Phase
Adenocarcinoma of the Prostate
 Radiation: Radiation Therapy
Drug: Androgen Suppression Therapy
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Stereotactic Body Radiation Therapy and Short-Term Androgen Ablation for Intermediate-Risk, Localized, Adenocarcinoma of the Prostate

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • Toxicity Assessment [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    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.

  • Quality of Life Assessment [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Assess the self-reported quality of life data 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.


Secondary Outcome Measures:
  • Various Control Rate Assessments [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Assess biochemical, clinical, and pathologic control rates associated with the combined hypofractionated dose regimen and ADT.

  • Dose Volume/ Imaging Data Assessments [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Collect dose/volume and imaging data to allow normal tissue complication probability modeling and targeting assessment for patients treated with hypofractionated radiation therapy.

  • Biomarker Studies [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Collect whole blood to perform correlative studies for serum cytokine profiling and future biomarker studies.


Estimated Enrollment: 103
Study Start Date: April 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Radiation with Androgen Suppression
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. This choice of daily dose is based on the prior published experience showing safety and efficacy of hypofractionated regimens.
 Radiation: Radiation Therapy
7.25 Gy every other day fractions to a total dose of 36.25 Gy (total of 5 fractions)
Drug: Androgen Suppression Therapy
Androgen deprivation therapy (ADT) for 4 months total, 2 months before and 2 months after the hypofractionated radiation delivered.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01517451

Contacts
Contact: Phuoc Tran, M.D., Ph.D. 410-614-3880 tranp@jhmi.edu
Contact: Shirley DiPasquale, R.N. 410-614-1598 sdipasq1@jhmi.edu

Locations
United States, Maryland
The Sidney Kimmel Comprehsive Cancer Center at Johns Hopkins Not yet recruiting
Baltimore, Maryland, United States, 21231
Principal Investigator: Phuoc Tran, M.D., Ph.D.            
Sub-Investigator: Fariba Asrari, M.D.            
Sub-Investigator: Theodore DeWeese, M.D.            
Sub-Investigator: Deborah Frassica, M.D.            
Sub-Investigator: Russelll Hales, M.D.            
Sub-Investigator: Danny Song, M.D.            
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Investigators
Principal Investigator: Phuoc Tran, M.D. The Johns Hopkins University School of Medicine
  More Information

No publications provided

Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01517451     History of Changes
Other Study ID Numbers: J11157, NA_00067963
Study First Received: January 20, 2012
Last Updated: February 12, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Adenocarcinoma
Adenocarcinoma, Mucinous
Prostatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Cystic, Mucinous, and Serous
Genital Neoplasms, Male
 Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013