Radiation and Androgen Ablation for Prostate Cancer

• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT01517451
• Collaborator: (none)
• Enrollment: 105
• Locations: 3
• Arm: 1
• Anticipated Duration (Months): 119.3
• Patients Per Site: 35
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Adenocarcinoma of the Prostate	Radiation: Radiation Therapy; Drug: Androgen Deprivation Therapy (ADT)	Phase 1/Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 105 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Stereotactic Body Radiation Therapy and Short-Term Androgen Ablation for Intermediate-Risk, Localized, Adenocarcinoma of the Prostate
• Actual Study Start Date: May 22, 2013
• Anticipated Primary Completion Date: May 1, 2023
• Anticipated Study Completion Date: May 1, 2023

Arms and Interventions

Arm

Intervention/Treatment

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 (stereotactic body radiation therapy). 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.

Outcome Measures

Primary Outcome Measures

1. Biochemical failure free-rate [1, 2, 3, 6 12, 18. 24, 30, 36 mont, 4 year and 5 year follow-up points after treatment has been completed]

   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

1. Various Control Rate Assessments [1 year]

   Assess biochemical, clinical, and pathologic control rates associated with the combined hypofractionated dose regimen and ADT.

2. Dose Volume/ Imaging Data Assessments [1 year]

   Collect dose/volume and imaging data to allow normal tissue complication probability modeling and targeting assessment for patients treated with hypofractionated radiation therapy.

3. Biomarker Studies [1 year]

   Collect whole blood to perform correlative studies for serum cytokine profiling and future biomarker studies.

4. Gastrointestinal (GI) and Genitourinary (GU toxicity) assessment [1 year]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sibley Memorial Hospital	Washington	District of Columbia	United States	20016
2	The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland	United States	21231
3	Suburban Hospital	Bethesda	Maryland	United States	20814

Sponsors and Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Investigators

• Principal Investigator: Phuoc Tran, M.D., Johns Hopkins University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• ClinicalTrials.gov Identifier: NCT01517451
• Other Study ID Numbers: J11157; NA_00067963
• First Posted: Jan 25, 2012
• Last Update Posted: May 27, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Additional relevant MeSH terms: Adenocarcinoma; Prostatic Neoplasms; Androgens

Study Results

No Results Posted as of May 27, 2022