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.
Recruiting
Phase 3
| Name | Type | Description | Interventions |
|---|---|---|---|
| Proton Radiation Hypofractionation | Other | 5 fractions (7.6 Gy(RBE) x 5) | |
| Proton Radiation Standard Fractionation | Active Comparator | 44 fractions (1.8 Gy(RBE) x 44) |
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).
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | Male |
| Healthy Volunteers: | No |
| Measure: | 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 |
| Safety Issue: | |
| Description: | 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. |
| Measure: | 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 |
| Safety Issue: | |
| Description: |
| Phase: | Phase 3 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Proton Collaborative Group |
July 12, 2019
