## Protocol Section
### Identification Module
**NCT ID:** NCT02334579

**Brief Title:** Stereotactic Body Radiotherapy for Stage I-III Prostate Cancer

**Official Title:** Function-Preserving Stereotactic Body Radiotherapy for Clinical State I-III Prostate Cancer

#### Organization Study ID Info
**ID:** IR 5642
#### Organization
**Class:** OTHER
**Full Name:** Swedish Medical Center
### Status Module
#### Completion Date
**Date:** 2024-12

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-07-12

**Type:** ACTUAL

**Last Update Submit Date:** 2019-07-11

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2023-12

**Type:** ESTIMATED

#### Start Date
**Date:** 2014-12

**Status Verified Date:** 2019-07

#### Study First Post Date
**Date:** 2015-01-08
**Type:** ESTIMATED
**Study First Submit Date:** 2014-12-04
**Study First Submit QC Date:** 2015-01-06
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Swedish Medical Center

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The purpose of this study is to find out the effects (good and bad) of highly focused radiation on you and your prostate cancer. The purpose of this evaluation is to see if this treatment causes fewer side effects that other standard treatment approaches, and to evaluate the effect of this treatment on your prostate tumor and your quality of life over time.

### Conditions Module

**Conditions:**

- Prostate Cancer

- Prostatic Cancer

- Prostate Neoplasms

- Prostatic Neoplasms

- Cancer of the Prostate

**Keywords:**

- Radiation

- Stereotactic Radiosurgery

- Radiotherapy

- Prostate Tumor

- Prostate Surgery

- CyberKnife

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 146

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** This treatment concentrates large doses of radiation onto the tumor so that injury from radiation to the nearby normal tissue will be minimal. CyberKnife Stereotactic Radiosurgery is not investigational and is considered standard of care.

**Intervention Names:**

- Radiation: CyberKnife Stereotactic Radiosurgery

**Label:** CyberKnife Stereotactic Radiosurgery

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- CyberKnife Stereotactic Radiosurgery

**Description:** Five treatments given over about one week.

**Name:** CyberKnife Stereotactic Radiosurgery

**Type:** RADIATION

### Outcomes Module

#### Other Outcomes

**Description:** Measure quality of life after five years following cyberknife stereotactic radiosurgery.

**Measure:** Quality of life

**Time Frame:** 5 years

#### Primary Outcomes

**Description:** In the low- and intermediate-risk prostate cancer groups, to determine whether study treatment improves patient-reported quality of life outcomes compared to the approach used in a previous multi-center cyberknife stereotactic radiosurgery trial.

**Measure:** Quality of life outcomes (low- and intermediate-risk prostate cancer groups)

**Time Frame:** 8 years

**Description:** In the high-risk group, to estimate rates of acute and late grade 3-5 gastrointestinal and genitourinary toxicities following cyberknife stereotactic radiosurgery.

**Measure:** Rates of acute and late grade 3-5 gastrointestinal and genitourinary toxicities (high-risk group)

**Time Frame:** 8 years

#### Secondary Outcomes

**Description:** After five years following cyberknife stereotactic radiosurgery, estimate rates of toxicities related to treatment.

**Measure:** Rates of toxicities related to treatment

**Time Frame:** 5 years

**Description:** Measure disease free survival after five years following cyberknife stereotactic radiosurgery.

**Measure:** Disease free survival

**Time Frame:** 5 years

**Description:** Measure overall survival after five years following cyberknife stereotactic radiosurgery.

**Measure:** Overall survival

**Time Frame:** 5 years

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Histologically proven prostate adenocarcinoma
* Clinical stage T1a-T3, N0-Nx, M0-Mx
* Patients belonging in one of the following risk groups: (1) LOW RISK: CS T1a-T2a, Gleason 2-6, PSA\<10, Nx-0, Mx-0; (2) INTERMEDIATE RISK: CS T2b, Gleason ≤7, PSA\<20, Nx-0, Mx-0, or CS T1a-T2b, Gleason 2-6, PSA≥10 \& \<20, Nx-0, Mx-0, or CS T1a-T2b, Gleason 7, PSA≤20, Nx-0, Mx-0; or (3) HIGH RISK: CS T2c-T3, any Gleason, any PSA, or CS T1-3, Gleason ≥8 and/or PSA≥20
* Karnofsky performance status 70-100
* Hormone therapy: includes LHRH agonists (e.g. leuprolide, goserelin, triptorelin), antagonists (e.g. degarelix), peripheral blockers (e.g. flutamide, bicalutamide, nilutamide), estrogens (e.g. DES) and bilateral orchiectomy
* Low and Intermediate risk groups: no hormone ablation for two months prior to enrollment, or during treatment
* High risk group: three hormone therapy regimens are allowed
* 5-alpha reductase inhibitors (e.g., finasteride or dutasteride) are allowed

Exclusion Criteria:

* Prior prostatectomy or cryotherapy of the prostate
* Prior high-dose radiotherapy to the prostate or lower pelvis
* Implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** mary.monahan@swedish.org

**Name:** Mary Monahan

**Phone:** (206) 320-7129

**Role:** CONTACT

**Contact 2:**

**Email:** robert.meier@swedish.org

**Name:** Robert Meier, MD

**Phone:** (206) 320-7130

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Seattle

**Contacts:**

***Contact 1:***

- **Email:** mary.monahan@swedish.org

- **Name:** Mary Monahan

- **Phone:** 206-320-7029

- **Role:** CONTACT

***Contact 2:***

- **Email:** robert.meier@swedish.org

- **Name:** Robert Meier, MD

- **Phone:** (206) 320-7130

- **Role:** CONTACT

***Contact 3:***

- **Name:** Robert Meier, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** Swedish Medical Center Radiosurgery Center

**State:** Washington

**Status:** RECRUITING

**Zip:** 98122

#### Overall Officials

**Official 1:**

**Affiliation:** Swedish Medical Center Radiosurgery Center

**Name:** Robert Meier, MD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### See Also Links

**Label:** Swedish Medical Center Radiosurgery Center

**URL:** http://www.swedish.org/services/radiosurgery-center

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000005834

- Term: Genital Neoplasms, Male

- ID: D000014565

- Term: Urogenital Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000005832

- Term: Genital Diseases, Male

- ID: D000091662

- Term: Genital Diseases

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000011469

- Term: Prostatic Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M14335

- Name: Prostatic Neoplasms

- Relevance: HIGH

- As Found: Prostate Cancer

- ID: M8946

- Name: Genital Neoplasms, Male

- Relevance: LOW

- As Found: Unknown

- ID: M17315

- Name: Urogenital Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8944

- Name: Genital Diseases, Male

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14333

- Name: Prostatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000011471

- Term: Prostatic Neoplasms

- ID: D000009369

- Term: Neoplasms

### Misc Info Module

- Version Holder: 2024-05-24
