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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Proton Collaborative Group
Sponsor:
Information provided by (Responsible Party):
Proton Collaborative Group
ClinicalTrials.gov Identifier:
NCT01492972
First received: December 9, 2011
Last updated: September 4, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Radiation: Proton Radiation
Drug: Androgen Suppression Therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase III Study of Mildly Hypo-fractionated Image Guided Proton Beam Radiation Therapy With or Without Androgen Suppression for Intermediate Risk Adenocarcinoma of the Prostate

Resource links provided by NLM:


Further study details as provided by Proton Collaborative Group:

Primary Outcome Measures:
  • Morbidity Outcomes [ Time Frame: after the initial 100 patients have had a median follow up of at least three years and then every year. ] [ Designated as safety issue: No ]

    To determine if androgen suppression along with high dose proton radiation therapy will result in a higher freedom from failure (FFF) than high dose proton 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 [ Time Frame: At 6 months ] [ Designated as safety issue: Yes ]
    Assessment of grade 2 or higher GU and GI toxicity using CTCAE 4.0 criteria

  • Frequency and severity of GI and GU toxicity [ Time Frame: At 3 years ] [ Designated as safety issue: Yes ]
  • Incidence of quality of life issues [ Time Frame: At completion of radiation therapy ] [ Designated as safety issue: No ]
  • Incidence of Freedom from biochemical failure (FFBF) [ Time Frame: At 5 years ] [ Designated as safety issue: No ]
  • Incidence of clinical failure: local and/or distant [ Time Frame: At 5 years ] [ Designated as safety issue: No ]
  • Incidence of salvage Androgen Suppression use (SAD) [ Time Frame: At 5 years ] [ Designated as safety issue: No ]
  • Incidence of progression free survival: using clinical, biochemical and SAD as events [ Time Frame: At 5 years ] [ Designated as safety issue: No ]
  • Incidence of overall survival [ Time Frame: At 5 years ] [ Designated as safety issue: No ]
  • Incidence of disease-specific survival [ Time Frame: At 5 years ] [ Designated as safety issue: No ]
  • Correlate pathologic and radiologic findings with outcomes [ Time Frame: At 5 years ] [ Designated as safety issue: No ]
  • Correlate PSA and free PSA levels with outcomes [ Time Frame: At 5 years ] [ Designated as safety issue: No ]
  • Correlate testosterone levels and variation with proton therapy and outcomes [ Time Frame: At 5 years ] [ Designated as safety issue: No ]
  • Prospectively collect information that will help to define dose-volume relationships of normal structures with acute and chronic toxicity [ Time Frame: At 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 192
Study Start Date: January 2012
Estimated Study Completion Date: December 2021
Estimated Primary Completion Date: December 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Proton Radiation Alone
Proton Radiation Total Dose=70 Gy(RBE)
Radiation: Proton Radiation

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))

Experimental: Proton Radiation + Androgen Suppression
Androgen Suppression Therapy x 6 months + Proton Radiation Total Dose 70 Gy(RBE)
Radiation: Proton Radiation

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))

Drug: Androgen Suppression Therapy
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)
Other Name: leuprolide, goserelin, buserelin, or triptorelin

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  • IPSS ≤ 16.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01492972

Contacts
Contact: Megan Dunn, PhD,MSHS 630-657-0092 mdunn@pcgresearch.org

Locations
United States, Illinois
CDH Proton Center Recruiting
Warrenville, Illinois, United States, 60555
Contact: Research Coordinator    630-821-6397      
Principal Investigator: John Chang, MD         
United States, Oklahoma
ProCure Proton Therapy Center Recruiting
Oklahoma City, Oklahoma, United States, 73142
Contact: Tisha Adams, MS, CCRC    405-773-6775    tisha.adams@okc.procure.com   
Principal Investigator: Gary Larson, MD         
United States, Virginia
Hampton University Proton Therapy Institute Recruiting
Hampton, Virginia, United States, 23666
Contact: Scott Acker    757-251-6856    scott.acker@hamptonproton.org   
Principal Investigator: Christopher Sinesi, MD         
Sponsors and Collaborators
Proton Collaborative Group
Investigators
Principal Investigator: Carlos Vargas, MD Proton Collaborative Group
  More Information

No publications provided

Responsible Party: Proton Collaborative Group
ClinicalTrials.gov Identifier: NCT01492972     History of Changes
Other Study ID Numbers: GU003-10
Study First Received: December 9, 2011
Last Updated: September 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Proton Collaborative Group:
Prostate
proton
radiation
intermediate risk

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 29, 2014