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Feasibility of Hormones and Radiation for Intermediate or High Risk Prostate Cancer | Clinical Trials | Clareo Health

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Feasibility of Hormones and Radiation for Intermediate or High Risk Prostate Cancer

A Feasibility Study of Oral Hormonal Therapy and Radiation for Non-metastatic, Intermediate or High Risk Prostate Cancer in Men 70 and Older or With Medical Comorbidities

NCT01342367•University of Chicago

View on ClinicalTrials.gov

Summary

The purpose of this study is see if quality of life is improved in patients receiving oral hormone therapy compared to standard of care. The study will also compare survival rates between patients receiving oral hormone therapy and those receiving standard of care.

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Age \> or = 70 years and/or Charlson comorbidity index score \> or = 2
•Pathologically (histologically) proven diagnosis of prostatic adenocarcinoma
•Two or more of the following intermediate risk features for recurrence, Gleason Score = 7, PSA 10-20 ng/ml, Clinical Stage T2b-T2c Percent positive biopsy cores \> or = 50%
•One or more of the following high risk features for recurrence, Gleason Score 8-10, PSA \> 20 ng/ml, Clinical Stage T3a-T4
•Clinically negative lymph nodes as established by imaging, nodal sampling, or dissection
•No evidence of bone metastases on bone scan
•History/physical examination via the Charlson Comorbidity Index within 60 days prior to registration
•Zubrod Performance Status 0-2
•Age \> or = 18
•Baseline serum PSA within 60 days prior to registration
+5 more criteria

Exclusion Criteria

•Prior radical surgery (prostatectomy), high-intensity focused ultrasound (HIFU) or cryosurgery for prostate cancer
•Prior hormonal therapy, such as LHRH agonists (e.g., goserelin, leuprolide), antiandrogens (e.g., flutamide, bicalutamide), estrogens (e.g., DES), or bilateral orchiectomy
•Use of 5-alpha reductase inhibitors (finasteride, dutasteride) specifically prescribed for the treatment of prostate cancer
•Prior or concurrent cytotoxic chemotherapy for prostate cancer; prior chemotherapy for a different cancer is permitted
•Prior radiation, including brachytherapy, to the region of the prostate that would result in overlap of RT fields
•Active lupus or scleroderma
•Severe, active co-morbidity, including but not limited to,unstable angina within the last 6 months without subsequent corrective cardiovascular procedure,or acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
•Hepatic insufficiency with AST, ALT, or Bilirubin \> 2 x upper limit of normal,clinical jaundice, and/or coagulation defects
•Acquired Immune Deficiency Syndrome (AIDS); note, however, that HIV testing is not required for entry into this protocol.Patients who are HIV seropositive but do not meet criteria for diagnosis of AIDS are eligible for study participation

Locations (1)

University of Chicago

Chicago, Illinois, United States

Key Dates

Start Date

December 17, 2010

Primary Completion Date

May 1, 2020

Completion Date

February 1, 2026

Last Updated

June 10, 2025

Enrollment

ACTUAL participants

Conditions

Prostate Cancer

Interventions

Bicalutamide

DRUG

Dutasteride

DRUG

Finasteride

DRUG

Radiation

RADIATION

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

NCT05691465

Metastatic Prostate Adenocarcinoma With Neuroendocrine DifferentiationMetastatic Prostate Neuroendocrine Carcinoma+2 more

View study

RECRUITINGPHASE2

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

NCT06842498

Metastatic Castration-Resistant Prostate Cancer

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 10, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Feasibility of Hormones and Radiation for Intermediate or High Risk Prostate Cancer

Inclusion Criteria

Exclusion Criteria

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

PSMA-PET: Deep Radiomic Biomarkers of Progression and Response Prediction in Prostate Cancer

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

Phase 2a Study of High-Dose Testosterone Followed by Radioligand Therapy in mCRPC