Study of Hypo-fractionated Proton Radiation for Low Risk Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT01230866|
Recruitment Status : Active, not recruiting
First Posted : October 29, 2010
Last Update Posted : April 4, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Radiation: Proton Radiation Hypofractionation Radiation: Proton Radiation Standard Fractionation||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase III Prospective Randomized Trial of Standard-fractionation vs. Hypo-fractionation With Proton Radiation Therapy for Low Risk Adenocarcinoma of the Prostate|
|Study Start Date :||November 2010|
|Estimated Primary Completion Date :||December 2023|
Proton Radiation Hypofractionation
5 fractions (7.6 Gy(RBE) x 5)
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
Active Comparator: Proton Radiation Standard Fractionation
44 fractions (1.8 Gy(RBE) x 44)
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
- To assess if hypo-fractionation will result in 2-year freedom from failure (FFF) that is non-inferior to 2-year 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 ]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 the incidence of grade 2 or greater GU and GI toxicity in each of the regimens. [ Time Frame: At 6 months and 2 years post randomization ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Male|
|Accepts Healthy Volunteers:||No|
- 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.
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01230866
|United States, Arizona|
|Mayo Clinic Cancer Center|
|Phoenix, Arizona, United States, 85054|
|United States, Illinois|
|Northwestern Medicine Chicago Proton Center|
|Warrenville, Illinois, United States, 60555|
|United States, Maryland|
|Maryland Proton Treatment Center|
|Baltimore, Maryland, United States, 21201|
|United States, Oklahoma|
|Oklahoma Proton Center|
|Oklahoma City, Oklahoma, United States, 73142|
|United States, Virginia|
|Hampton University Proton Therapy Institute|
|Hampton, Virginia, United States, 23666|
|Study Chair:||Carlos Vargas, MD||Proton Collaborative Group|
|Responsible Party:||Proton Collaborative Group|
|Other Study ID Numbers:||
|First Posted:||October 29, 2010 Key Record Dates|
|Last Update Posted:||April 4, 2023|
|Last Verified:||April 2023|
Proton Radiation Prostate Cancer
Genital Neoplasms, Male
Neoplasms by Site
Genital Diseases, Male
Male Urogenital Diseases