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Proton Radiation Total Dose=70 Gy(RBE) OR High Dose Radiation with IMRT Alone=81 Gy OR Intraoperative LDR Brachytherapy and IMRT=45 Gy

Androgen Suppression Therapy x 6 months + Radiation

Consists of:

1. Conformal Proton Radiation Dose: 2.5 Gy (RBE) five days a week in 28 treatments over 5.5-6.5 weeks (total dose: 70 Gy (RBE))
2. High Dose Radiation with IMRT alone: 1.8 Gy five days a week in 45 treatments over 9-10 weeks (total dose: 81 Gy)
3. Intraoperative LDR Brachytherapy and IMRT: 100Gy Pad103 implant and IMRT 1.8 Gy five days a week in 25 treatments over 5-6 weeks (total dose: 45 Gy)

Radiation

Androgen suppression will begin 8 - 10 weeks prior to the start of RT for a total of 6 (+/- 2) months. Luteinizing Hormone-Releasing Hormone (LHRH) agonist therapy will consist of analogs approved by the FDA (or by Health Canada for Canadian institutions)

Androgen Suppression Therapy

Matthew Morocco

: Clinical Trials Office - All Mayo Clinic Locations

Don Smith, MS, CCRC

Stephen Mihalcik, MD

Jenny Washington, BSRT(T), CMD

John Chang, MD

Donna Sternberg, RN, BSN, OCN

Christopher Sinesi, MD

Carlos Vargas, MD

The purpose of this study is to compare the effects, good and/or bad of two treatment methods on subjects and their cancer.

Proton beam radiation therapy is one of the treatments for men with prostate cancer who have localized disease. The benefit of the combination with androgen suppression is not completely understood. This study will compare the use of hypofraction proton therapy (28 treatments) alone to proton therapy with androgen suppression therapy.

Hypo-fractionated Radiation Therapy With or Without Androgen Suppression for Intermediate Risk Prostate Cancer

Phase III Study of Image Guided Radiation Therapy With or Without Androgen Suppression for Intermediate Risk Adenocarcinoma of the Prostate

To determine if androgen suppression along with radiation therapy will result in a higher freedom from failure (FFF) than radiation therapy without androgen suppression.

Freedom from failure (FFF): The events for FFF will be the first occurrence of clinical failure (local recurrence, regional recurrence, or distant metastasis), biochemical failure by the Phoenix definition (PSA ≥ 2 ng/ml over the current nadir PSA) (45) discounting bounces per investigator discretion, or the start of salvage therapy including androgen suppression

Assessment of grade 2 or higher GU and GI toxicity using CTCAE 4.0 criteria

Proton Collaborative Group

Heart and Blood Diseases

Coronary Artery Disease

Myocardial Ischemia

Coronary Disease

Nuclear MPI for CAD for prostate cancer subjects undergoing treatment and development of normal comparison.

Nuclear rest/stress testing of the heart using N-13-ammonia paired with brachial artery ultrasound

PET scan and ultrasound

Terrence Ruddy, MD

Suppression of effects of androgens with male sex hormones, androgen suppression treatment (AST), has been known to reduce deaths and prolong life in advanced prostate cancer. There have, however, been concerns raised in previous studies that androgen suppression may be associated with increased rate of heart attacks, particularly in older men. This study looks at prostate cancer patients in The Ottawa Hospital Cancer Clinic to see if treating these patients with androgen suppression is associated with a decrease in blood flow to the heart muscles by using Positron Emission Tomography (PET) and brachial artery ultrasound.

Treatment group: Prior to the initiation of AST, subjects will have a baseline N-13-ammonia PET scan and a brachial artery ultrasound at the University of Ottawa Heart Institute. Blood glucose and a lipid profile will be obtained. These tests will be repeated 6 - 9 months after starting AST.

Cancer control group: The same testing and intervals will be performed. Normals control group: Baseline testing will be done to establish a normal.

Study to Monitor the Effects of Androgen Suppression Treatment on the Heart

Does Androgen Suppression Treatment In Prostate Cancer Reduce Myocardial Blood Flow Reserve?

The change in global absolute MFR between baseline and follow up PET studies, at a patient level. MFR is defined as the ratio between regional blood flow with maximum vasodilation and baseline regional blood flow.

The change in absolute MFR between baseline and follow up tests for the 3 major coronary territories. Territories with severe reduction in flow or no flow on baseline images will be censored from this analysis. Regional myocardial perfusion will be assessed semi-quantitatively by summed stress scores and summed difference scores in each of the PET scans in the treatment and control groups.

Two-dimensional scans and pulse measures will be taken of the brachial artery with flow-mediated vasodilatation expressed as a percent change in arterial diameter from resting diameter.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Hypo-fractionated Radiation Therapy With or Without Androgen Suppression for Intermediate Risk Prostate Cancer	NCT01492972	Prostate Cancer	Radiation Androgen Suppre...	18 Years -	Proton Collaborative Group
Hypo-fractionated Radiation Therapy With or Without Androgen Suppression for Intermediate Risk Prostate Cancer	NCT01492972	Prostate Cancer	Radiation Androgen Suppre...	18 Years -	Proton Collaborative Group
Study to Monitor the Effects of Androgen Suppression Treatment on the Heart	NCT01230905	Prostate Cancer	PET scan and ul...	40 Years - 80 Years	Ottawa Heart Institute Research Corporation
Hypo-fractionated Radiation Therapy With or Without Androgen Suppression for Intermediate Risk Prostate Cancer	NCT01492972	Prostate Cancer	Radiation Androgen Suppre...	18 Years -	Proton Collaborative Group

Spots Global Cancer Trial Database for androgen suppression therapy