Study of Hypo-fractionated Proton Radiation for Low Risk Prostate Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Proton Collaborative Group
Sponsor:
Information provided by (Responsible Party):
Proton Collaborative Group
ClinicalTrials.gov Identifier:
NCT01230866
First received: October 27, 2010
Last updated: June 12, 2014
Last verified: June 2014

October 27, 2010
June 12, 2014
November 2010
December 2018   (final data collection date for primary outcome measure)
To determine if hypo-fractionation will result in freedom from failure (FFF) that is equivalent to FFF following standard fractionation. FFF will be measured by recurrence, metastasis, PSA or start of salvage therapy. [ Time Frame: At 5 years post treatment completion +/- 90 days ] [ Designated as safety issue: No ]
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),or the start of salvage therapy including androgen deprivation.
To determine if hypo-fractionation will result in freedom from failure (FFF) that is equivalent to FFF following standard fractionation. FFF will be measured by recurrence, metastasis, PSA or start of salvage therapy. [ Designated as safety issue: No ]
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),or the start of salvage therapy including androgen deprivation.
Complete list of historical versions of study NCT01230866 on ClinicalTrials.gov Archive Site
  • To determine the incidence of grade 2 or greater GU and GI toxicity in each of the regimens [ Time Frame: At 6 months, 2 years and estimate at 3 years after treatment completion ] [ Designated as safety issue: Yes ]
  • To assess quality of life issues following completion of radiation therapy [ Time Frame: At 6 months and at 2-years ] [ Designated as safety issue: No ]
  • To assess incidence of impotence after the use of proton therapy [ Time Frame: At 3 years ] [ Designated as safety issue: No ]
  • To determine freedom from biochemical failure (BF) [ Time Frame: At 5 years ] [ Designated as safety issue: Yes ]
  • To determine clinical failure: local and/or distant [ Time Frame: At 5 years ] [ Designated as safety issue: Yes ]
  • To determine salvage androgen deprivation use (SAD) [ Time Frame: At 5 years ] [ Designated as safety issue: No ]
  • To determine progression free survival: using clinical, biochemical and SAD as events [ Time Frame: At 5 years ] [ Designated as safety issue: Yes ]
  • To determine overall survival [ Time Frame: At 5 years ] [ Designated as safety issue: Yes ]
  • To determine disease-specific survival [ Time Frame: At 5 years ] [ Designated as safety issue: Yes ]
  • To estimate prostate and normal structures movement during RT with the use of scans [ Time Frame: At 5 years ] [ Designated as safety issue: No ]
  • To correlate pathologic and radiologic findings with outcomes [ Time Frame: At 5 years ] [ Designated as safety issue: No ]
  • To correlate PSA and free PSA levels with outcomes [ Time Frame: At 5 years ] [ Designated as safety issue: No ]
  • To correlate Testosterone levels and variation with proton therapy and outcomes [ Time Frame: At 5 years ] [ Designated as safety issue: No ]
  • To develop a quality assurance process for proton prostate therapy [ Time Frame: At 5 years ] [ Designated as safety issue: No ]
  • To 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 ]
  • To allow for future research of pathologic risk factors that may influence prognosis; this information will help us to attempt to characterize their presence in low and intermediate risk prostate cancer and their potential effect on outcomes [ Time Frame: At 5 years ] [ Designated as safety issue: No ]
  • To compare an IMRT plan with the proton therapy radiation plan [ Time Frame: At 5 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Study of Hypo-fractionated Proton Radiation for Low Risk Prostate Cancer
A Phase III Prospective Randomized Trial of Standard-fractionation vs. Hypo-fractionation With Proton Radiation Therapy for Low Risk Adenocarcinoma of the Prostate

The purpose of this study is to compare the effects (good and bad) on patients with prostate cancer by comparing the standard dose of radiation therapy (44 treatments over 8½-9 weeks) with a higher daily dose of radiation (5 treatments over 1-2 weeks) to see if the effects of the treatments are similar or better.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
  • Radiation: Proton Radiation Hypofractionation
    Dose: 38 Gy(RBE); 7.6 GY(RBE) five days a week in 5 treatments over 1-2 weeks
    Other Name: Particle Therapy
  • Radiation: Proton Radiation Standard Fractionation
    Dose: 79.2 GY(RBE); 1.8 GY(RBE) five days a week in 44 treatments over 8.5-9 weeks
    Other Name: Particle Therapy
  • Proton Radiation Hypofractionation
    5 fractions (7.6 Gy(RBE) x 5)
    Intervention: Radiation: Proton Radiation Hypofractionation
  • Active Comparator: Proton Radiation Standard Fractionation
    44 fractions (1.8 Gy(RBE) x 44)
    Intervention: Radiation: Proton Radiation Standard Fractionation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
192
Not Provided
December 2018   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically confirmed prostate adenocarcinoma within 365 days prior to randomization.
  • History/physical examination with digital rectal examination of the prostate and baseline toxicity assessment within 90 days prior to randomization.
  • Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material;Gleason score must be in the range of 2-6. > 6 cores are strongly recommended.
  • PSA values < 10 ng/ml within 90 days prior to randomization. Either done prior to biopsy or at least 21 days after prostate biopsy.
  • Clinical stages T1a-T2a N0 M0 (AJCC Criteria 7th Ed.). Staging must be done by treating investigator.
  • No pelvic lymph nodes > 1.5 cm in greatest dimension unless the enlarged lymph node is biopsied and negative.
  • Patients must be at least 18 years old.
  • ECOG performance status 0-1 (appendix I) documented within 90 days prior to randomization.
  • IPSS score < 16.
  • Patients must give IRB approved, study specific, informed consent.
  • Patients must complete all mandatory tests listed in section 4.0 within the specified time frames.
  • Patients must be able to start treatment within 56 days of randomization.

Exclusion Criteria:

  • Previous prostate cancer surgery to include: prostatectomy, hyperthermia and cryosurgery.
  • Previous pelvic radiation for prostate cancer.
  • Androgen deprivation therapy prior to radiation is allowed. However, it is not acceptable if continued during radiation or as adjuvant therapy.
  • Active rectal diverticulitis, Crohn's disease affecting the rectum, or ulcerative colitis.
  • 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, to have a biopsy if needed, or for marker placement).
  • Any major medical, addictive or psychiatric illnesses which would affect the consent process, completion of treatment and/or interfere with follow-up. Consent by legal authorized representative is not permitted in 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).
Male
18 Years and older
No
Contact: Megan Dunn, PhD,MSHS 630-657-0092 mdunn@pcgresearch.org
United States
 
NCT01230866
GU002-10
Yes
Proton Collaborative Group
Proton Collaborative Group
Not Provided
Study Chair: Carlos Vargas, MD Proton Collaborative Group
Proton Collaborative Group
June 2014

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