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

• Register: ClinicalTrials.gov
• Last refreshed on: 8 April 2013
• Main ID: NCT01230866
• Date of registration: 27/10/2010
• Primary sponsor: Proton Collaborative Group
• Public title: Study of Hypo-fractionated Proton Radiation for Low Risk Prostate Cancer
• Scientific title: A Phase III Prospective Randomized Trial of Standard-fractionation vs. Hypo-fractionation With Proton Radiation Therapy for Low Risk Adenocarcinoma of the Prostate
• Date of first enrolment: November 2010
• Target sample size: 192
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01230866
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Angela Piper, MBA, BA

• Name: Carlos Vargas, MD
• Affiliation: Proton Collaborative Group

Key inclusion & exclusion criteria

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).



Age minimum: 18 Years
Age maximum: N/A
Gender: Male

Health Condition(s) or Problem(s) studied

Prostate Cancer

Intervention(s)

Radiation: Proton Radiation Hypofractionation

Radiation: Proton Radiation Standard Fractionation

Primary Outcome(s)

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]

Secondary Outcome(s)

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]

To assess incidence of impotence after the use of proton therapy [Time Frame: At 3 years]

To assess quality of life issues following completion of radiation therapy [Time Frame: At 6 months and at 2-years]

To compare an IMRT plan with the proton therapy radiation plan [Time Frame: At 5 years]

To correlate pathologic and radiologic findings with outcomes [Time Frame: At 5 years]

To correlate PSA and free PSA levels with outcomes [Time Frame: At 5 years]

To correlate Testosterone levels and variation with proton therapy and outcomes [Time Frame: At 5 years]

To determine clinical failure: local and/or distant [Time Frame: At 5 years]

To determine disease-specific survival [Time Frame: At 5 years]

To determine freedom from biochemical failure (BF) [Time Frame: At 5 years]

To determine overall survival [Time Frame: At 5 years]

To determine progression free survival: using clinical, biochemical and SAD as events [Time Frame: At 5 years]

To determine salvage androgen deprivation use (SAD) [Time Frame: At 5 years]

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]

To develop a quality assurance process for proton prostate therapy [Time Frame: At 5 years]

To estimate prostate and normal structures movement during RT with the use of scans [Time Frame: At 5 years]

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]

Secondary ID(s)

GU002-10

Source(s) of Monetary Support

Please refer to primary and secondary sponsors