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

Primary Purpose

Prostate Cancer

Status

Recruiting

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Radiation

Androgen Suppression Therapy

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate, proton, radiation, intermediate risk

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Histologically confirmed prostate adenocarcinoma (within 365 days of randomization) at intermediate risk for reoccurrence determined by at least one of the following: Gleason Score 7, PSA > = 10 and < = 20, T stage T2b - T2c
Clinical stages T1-T2c N0 M0 as staged by the treating investigator. (AJCC Criteria 7th Ed.- appendix III).
Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material; Gleason score must be in the range of 2-7. > 6 cores are strongly recommended.
PSA values < = 20 ng/ml within 90 days prior to randomization. Obtained prior to biopsy or at least 21 days after prostate biopsy.
ECOG performance status 0-1 (appendix II) assessed within 90 days of randomization.
Patients must sign IRB approved study specific informed consent.
Patients must complete all required pre-entry tests listed in section 4.0 within the specified time frames.
Patients must be able to start treatment within 56 days of randomization.
Patients must be at least 18 years old.
For brachytherapy, an IPSS ≤ 21, or ≤ 17 if patient is on medications to improve urination.
For brachytherapy, prostate volume must be less than 55cc prior to AS.

Exclusion Criteria:

Pelvic lymph nodes > 1.5 cm in greatest dimension unless the enlarged lymph node is biopsied and negative.
Previous prostate cancer surgery to include: prostatectomy, hyperthermia and cryosurgery.
Previous pelvic radiation for prostate cancer.
Previous androgen suppression therapy for prostate cancer.
Active rectal diverticulitis, Crohn's disease affecting the rectum or ulcerative colitis (non-active diverticulitis and Crohn's disease not affecting the rectum are allowed).
Prior systemic chemotherapy for prostate cancer.
History of proximal urethral stricture requiring dilatation.
Current and continuing anticoagulation with warfarin sodium (Coumadin), heparin, low- molecular weight heparin, Clopidogrel bisulfate (Plavix), or equivalent (unless it can be stopped to manage treatment related toxicity or to have a biopsy if needed).
Major medical, addictive or psychiatric illness which in the investigator's opinion, will prevent the consent process, completion of the treatment and/or interfere with follow-up. (Consent by legal authorized representative is not permitted for this study).
Evidence of any other cancer within the past 5 years and < 50% probability of a 5 year survival. (Prior or concurrent diagnosis of basal cell or non-invasive squamous cell cancer of the skin is allowed).
History of myocardial infarction within the last 6 months.

Sites / Locations

Mayo ClinicRecruiting
Northwestern Medicine Chicago Proton CenterRecruiting
Oklahoma Proton CenterRecruiting
Hampton University Proton Therapy InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Radiation Alone

Radiation + Androgen Suppression

Arm Description

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

Outcomes

Primary Outcome Measures

Morbidity Outcomes

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

Secondary Outcome Measures

Frequency and severity of grade 2 or higher GU and GI toxicity

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

Frequency and severity of GI and GU toxicity

Incidence of quality of life issues

Incidence of Freedom from biochemical failure (FFBF)

Incidence of clinical failure: local and/or distant

Incidence of salvage Androgen Suppression use (SAD)

Incidence of progression free survival: using clinical, biochemical and SAD as events

Incidence of overall survival

Incidence of disease-specific survival

Correlate pathologic and radiologic findings with outcomes

Correlate PSA and free PSA levels with outcomes

Correlate testosterone levels and variation with proton therapy and outcomes

Prospectively collect information that will help to define dose-volume relationships of normal structures with acute and chronic toxicity

Full Information

NCT ID

NCT01492972

First Posted

December 9, 2011

Last Updated

April 1, 2023

Sponsor

Proton Collaborative Group

1. Study Identification

Unique Protocol Identification Number

NCT01492972

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 2012 (undefined)

Primary Completion Date

December 2025 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Proton Collaborative Group

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

Prostate, proton, radiation, intermediate risk

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

192 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Radiation Alone

Arm Type

Active Comparator

Arm Description

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

Arm Title

Radiation + Androgen Suppression

Arm Type

Experimental

Arm Description

Androgen Suppression Therapy x 6 months + Radiation

Intervention Type

Radiation

Intervention Name(s)

Radiation

Intervention Description

Consists of: 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)) High Dose Radiation with IMRT alone: 1.8 Gy five days a week in 45 treatments over 9-10 weeks (total dose: 81 Gy) 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)

Intervention Type

Drug

Intervention Name(s)

Androgen Suppression Therapy

Other Intervention Name(s)

leuprolide, goserelin, buserelin, or triptorelin

Intervention Description

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)

Primary Outcome Measure Information:

Title

Morbidity Outcomes

Description

Time Frame

after the initial 100 patients have had a median follow up of at least three years and then every year.

Secondary Outcome Measure Information:

Title

Frequency and severity of grade 2 or higher GU and GI toxicity

Description

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

Time Frame

At 6 months

Title

Frequency and severity of GI and GU toxicity

Time Frame

At 3 years

Title

Incidence of quality of life issues

Time Frame

At completion of radiation therapy

Title

Incidence of Freedom from biochemical failure (FFBF)

Time Frame

At 5 years

Title

Incidence of clinical failure: local and/or distant

Time Frame

At 5 years

Title

Incidence of salvage Androgen Suppression use (SAD)

Time Frame

At 5 years

Title

Incidence of progression free survival: using clinical, biochemical and SAD as events

Time Frame

At 5 years

Title

Incidence of overall survival

Time Frame

At 5 years

Title

Incidence of disease-specific survival

Time Frame

At 5 years

Title

Correlate pathologic and radiologic findings with outcomes

Time Frame

At 5 years

Title

Correlate PSA and free PSA levels with outcomes

Time Frame

At 5 years

Title

Correlate testosterone levels and variation with proton therapy and outcomes

Time Frame

At 5 years

Title

Prospectively collect information that will help to define dose-volume relationships of normal structures with acute and chronic toxicity

Time Frame

At 3 years

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histologically confirmed prostate adenocarcinoma (within 365 days of randomization) at intermediate risk for reoccurrence determined by at least one of the following: Gleason Score 7, PSA > = 10 and < = 20, T stage T2b - T2c Clinical stages T1-T2c N0 M0 as staged by the treating investigator. (AJCC Criteria 7th Ed.- appendix III). Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material; Gleason score must be in the range of 2-7. > 6 cores are strongly recommended. PSA values < = 20 ng/ml within 90 days prior to randomization. Obtained prior to biopsy or at least 21 days after prostate biopsy. ECOG performance status 0-1 (appendix II) assessed within 90 days of randomization. Patients must sign IRB approved study specific informed consent. Patients must complete all required pre-entry tests listed in section 4.0 within the specified time frames. Patients must be able to start treatment within 56 days of randomization. Patients must be at least 18 years old. For brachytherapy, an IPSS ≤ 21, or ≤ 17 if patient is on medications to improve urination. For brachytherapy, prostate volume must be less than 55cc prior to AS. Exclusion Criteria: Pelvic lymph nodes > 1.5 cm in greatest dimension unless the enlarged lymph node is biopsied and negative. Previous prostate cancer surgery to include: prostatectomy, hyperthermia and cryosurgery. Previous pelvic radiation for prostate cancer. Previous androgen suppression therapy for prostate cancer. Active rectal diverticulitis, Crohn's disease affecting the rectum or ulcerative colitis (non-active diverticulitis and Crohn's disease not affecting the rectum are allowed). Prior systemic chemotherapy for prostate cancer. History of proximal urethral stricture requiring dilatation. Current and continuing anticoagulation with warfarin sodium (Coumadin), heparin, low- molecular weight heparin, Clopidogrel bisulfate (Plavix), or equivalent (unless it can be stopped to manage treatment related toxicity or to have a biopsy if needed). Major medical, addictive or psychiatric illness which in the investigator's opinion, will prevent the consent process, completion of the treatment and/or interfere with follow-up. (Consent by legal authorized representative is not permitted for this study). Evidence of any other cancer within the past 5 years and < 50% probability of a 5 year survival. (Prior or concurrent diagnosis of basal cell or non-invasive squamous cell cancer of the skin is allowed). History of myocardial infarction within the last 6 months.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Matthew Morocco

Phone

630-836-8670

mmorocco@pcgresearch.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Carlos Vargas, MD

Organizational Affiliation

Proton Collaborative Group

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

85259-5499

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

: Clinical Trials Office - All Mayo Clinic Locations

Phone

855-776-0015 (toll free)

Facility Name

Northwestern Medicine Chicago Proton Center

City

Warrenville

State/Province

Illinois

ZIP/Postal Code

60555

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Don Smith, MS, CCRC

Phone

630-933-7820

donald.smith3@nm.org

First Name & Middle Initial & Last Name & Degree

William Hartsell, MD

Facility Name

Oklahoma Proton Center

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73142

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jenny Washington, BSRT(T), CMD

Phone

405-773-6700

jenny.washington@okcproton.com

First Name & Middle Initial & Last Name & Degree

John Chang, MD

Facility Name

Hampton University Proton Therapy Institute

City

Hampton

State/Province

Virginia

ZIP/Postal Code

23666

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Donna Sternberg, RN, BSN, OCN

Phone

757-251-6839

Donna.Sternberg@hamptonproton.org

First Name & Middle Initial & Last Name & Degree

Christopher Sinesi, MD

12. IPD Sharing Statement

Learn more about this trial

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

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