Radiation and Androgen Ablation for Prostate Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 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 7, 2014
Last verified: July 2014

January 20, 2012
July 7, 2014
May 2013
August 2015   (final data collection date for primary outcome measure)
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.
  • 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.
  • Toxicity Assessment [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    1) Assess the incidence of grade 3 or greater GU and GI 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.
Complete list of historical versions of study NCT01517451 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
Not Provided
Not Provided
 
Radiation and Androgen Ablation for Prostate Cancer
Stereotactic Body Radiation Therapy and Short-Term Androgen Ablation for Intermediate-Risk, Localized, Adenocarcinoma of the Prostate

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

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.

Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Adenocarcinoma of the Prostate
  • 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.
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.
Interventions:
  • Radiation: Radiation Therapy
  • Drug: Androgen Deprivation Therapy (ADT)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
105
August 2020
August 2015   (final data collection date for primary outcome measure)

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, unless intervention was greater than 5 years from beginning treatment for current prostate cancer.
  • Previous 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.
Male
18 Years and older
No
Contact: Phuoc Tran, M.D., Ph.D. 410-614-3880 tranp@jhmi.edu
Contact: Shirley DiPasquale, R.N. 410-614-1598 sdipasq1@jhmi.edu
United States
 
NCT01517451
J11157, NA_00067963
Yes
Sidney Kimmel Comprehensive Cancer Center
Sidney Kimmel Comprehensive Cancer Center
Not Provided
Principal Investigator: Phuoc Tran, M.D. The Johns Hopkins University School of Medicine
Sidney Kimmel Comprehensive Cancer Center
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP