Radiation and Androgen Ablation for Prostate Cancer

Adenocarcinoma of the Prostate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01517451
• Other study ID #: J11157
• Secondary ID: NA_00067963
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: May 22, 2013
• Est. completion date: December 2026

Study information

• Verified date: June 2024
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 105
• Est. completion date: December 2026
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of the Prostate
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland
United States	Suburban Hospital	Bethesda	Maryland
United States	Sibley Memorial Hospital	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biochemical failure free-rate	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.	1, 2, 3, 6 12, 18. 24, 30, 36 mont, 4 year and 5 year follow-up points after treatment has been completed
Secondary	Various Control Rate Assessments	Assess biochemical, clinical, and pathologic control rates associated with the combined hypofractionated dose regimen and ADT.	1 year
Secondary	Dose Volume/ Imaging Data Assessments	Collect dose/volume and imaging data to allow normal tissue complication probability modeling and targeting assessment for patients treated with hypofractionated radiation therapy.	1 year
Secondary	Biomarker Studies	Collect whole blood to perform correlative studies for serum cytokine profiling and future biomarker studies.	1 year
Secondary	Gastrointestinal (GI) and Genitourinary (GU toxicity) assessment	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.	1 year