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

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ClinicalTrials.gov Identifier: NCT01492972
Recruitment Status : Recruiting
First Posted : December 15, 2011
Last Update Posted : July 12, 2019
Sponsor:
Information provided by (Responsible Party):
Proton Collaborative Group

Tracking Information
First Submitted Date  ICMJE December 9, 2011
First Posted Date  ICMJE December 15, 2011
Last Update Posted Date July 12, 2019
Study Start Date  ICMJE January 2012
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 6, 2016)
Morbidity Outcomes [ Time Frame: after the initial 100 patients have had a median follow up of at least three years and then every year. ]
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
Original Primary Outcome Measures  ICMJE
 (submitted: December 13, 2011)
Morbidity Outcomes [ Time Frame: after the initial 100 patients have had a median follow up of at least three years and then every year. ]
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 discresion, or the start of salvage therapy including androgen suppression
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 13, 2011)
  • Frequency and severity of grade 2 or higher GU and GI toxicity [ Time Frame: At 6 months ]
    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 ]
  • Incidence of quality of life issues [ Time Frame: At completion of radiation therapy ]
  • Incidence of Freedom from biochemical failure (FFBF) [ Time Frame: At 5 years ]
  • Incidence of clinical failure: local and/or distant [ Time Frame: At 5 years ]
  • Incidence of salvage Androgen Suppression use (SAD) [ Time Frame: At 5 years ]
  • Incidence of progression free survival: using clinical, biochemical and SAD as events [ Time Frame: At 5 years ]
  • Incidence of overall survival [ Time Frame: At 5 years ]
  • Incidence of disease-specific survival [ Time Frame: At 5 years ]
  • Correlate pathologic and radiologic findings with outcomes [ Time Frame: At 5 years ]
  • Correlate PSA and free PSA levels with outcomes [ Time Frame: At 5 years ]
  • Correlate testosterone levels and variation with proton therapy and outcomes [ Time Frame: At 5 years ]
  • Prospectively collect information that will help to define dose-volume relationships of normal structures with acute and chronic toxicity [ Time Frame: At 3 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hypo-fractionated Radiation Therapy With or Without Androgen Suppression for Intermediate Risk Prostate Cancer
Official Title  ICMJE Phase III Study of Image Guided Radiation Therapy With or Without Androgen Suppression for Intermediate Risk Adenocarcinoma of the Prostate
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Radiation: 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)
  • 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
Study Arms  ICMJE
  • Active Comparator: Radiation Alone
    Proton Radiation Total Dose=70 Gy(RBE) OR High Dose Radiation with IMRT Alone=81 Gy OR Intraoperative LDR Brachytherapy and IMRT=45 Gy
    Intervention: Radiation: Radiation
  • Experimental: Radiation + Androgen Suppression
    Androgen Suppression Therapy x 6 months + Radiation
    Interventions:
    • Radiation: Radiation
    • Drug: Androgen Suppression Therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 13, 2011)
192
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Tish Adams, MS, CCRC, CP 630-836-8668 tadams@pcgresearch.org
Contact: Matthew Morocco, BS 630-836-8670 mmorocco@pcgresearch.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01492972
Other Study ID Numbers  ICMJE GU003-10
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Proton Collaborative Group
Study Sponsor  ICMJE Proton Collaborative Group
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Carlos Vargas, MD Proton Collaborative Group
PRS Account Proton Collaborative Group
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP