Trial record 2 of 111 for:    Radiation with Androgen Deprivation

Radiation and Androgen Ablation for Prostate Cancer

This study is currently recruiting participants.
Verified July 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: July 3, 2013
Last verified: July 2013
  Purpose

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


Condition Intervention Phase
Adenocarcinoma of the Prostate
Radiation: Radiation Therapy
Drug: Androgen Deprivation Therapy (ADT)
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:


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

Primary Outcome Measures:
  • Biochemical failure free-rate [ Time Frame: 1, 2, 3, 6 12, 18. 24, 30, 36 mont, 4 year and 5 year follow-up points after treatment has been completed ] [ Designated as safety issue: No ]
    To assess 5-year biochemical failure free rate (BFFR) associated 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.

  • Gastrointestinal (GI) and Genitourinary (GU 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.


Estimated Enrollment: 105
Study Start Date: May 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 Deprivation Therapy (ADT)
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, greater than or equal to 1 month prior to SBRT. 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 Deprivation Therapy (ADT)
Androgen deprivation therapy (ADT) for 4 months total, greater than or equal to 1 month prior to SBRT.

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.

  Eligibility

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

Inclusion Criteria:

  • Histologically confirmed, locally confined adenocarcinoma of the prostate
  • 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 Comprehensive Cancer Center at Johns Hopkins 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: Russell 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: July 3, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 14, 2014