Radiation and Androgen Ablation for Prostate Cancer

• Status: Active, not recruiting
• Trial end date: 2023-05-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Treatments: Androgens; Ascorbic Acid; Estrogens, Conjugated (USP); Methyltestosterone

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, 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.