Radiation and Androgen Ablation for Prostate Cancer

Johns Hopkins Medicine

Status and phase: Active, not recruiting; Phase 2; Phase 1

Conditions: Adenocarcinoma of the Prostate

Treatments: Drug: Androgen Deprivation Therapy (ADT); Radiation: Radiation Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01517451

NA_00067963 (Other Identifier)

J11157

Details and patient eligibility

About

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

Full 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.

Enrollment: 105 patients

Sex: Male

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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105 participants in 1 patient group

Radiation with Androgen Deprivation Therapy (ADT)

Experimental group

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, 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.

Treatment:

Radiation: Radiation Therapy

Drug: Androgen Deprivation Therapy (ADT)