Postoperative or Salvage Radiotherapy for Node Negative Prostate Cancer Following Radical Prostatectomy
This phase II clinical trial tests the effects (good and/or bad) and how well postoperative or salvage radiotherapy works for the treatment of node negative prostate cancer following radical prostatectomy. The current standard of care is a range of treatment doses with postoperative or salvage radiotherapy. This range is slightly higher for salvage radiation than for postoperative radiation. Researchers want to establish guidelines for radiotherapy by collecting data to set a baseline treatment dose for future possible escalation trials.
Inclusion Criteria
- Pathologically confirmed adenocarcinoma of the prostate treated primarily with open, laparoscopic or robotically assisted prostatectomy
- Pathological stage T2a-T3b (American Joint Committee on Cancer [AJCC] Criteria 8th edition [Ed.]) adenocarcinoma of the prostate
- Maximum prostate specific antigen (PSA) value of 20 ng/ml (after prostatectomy)
- At least one of the following risk factors as the indication for radiation: * If post-op radiotherapy: ** Extracapsular penetration ** Positive surgical margins ** Invasion of the seminal vesicles ** A persistently elevated post prostatectomy PSA (> 0.2 ng/ml that does not meet the definition of PSA recurrence, in the absence of detectable distant metastasis * If salvage radiotherapy: ** Biopsy proven and/or radiographically defined local-regional relapse ** Biochemical relapse after a non-detectable post prostatectomy PSA defined as a PSA that increases on 2 or more determinations to >0.03; or a persistent PSA elevation of >= 0.2 following prostatectomy, in the absence of detectable distant metastasis
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1 within 90 days prior to study registration
- Patient must give study-specific informed consent on an Institutional Review Board (IRB)-stamped consent prior to any research related procedures or study treatment
- Patient must be at least 18 years old at the time of consent
- Hemoglobin >= 10 g/dl within 90 days prior to study registration
- Alkaline phosphatase within 90 days prior to study registration. If elevated, patient must have clinical correlation to assess for metastases. (Plain x-ray, CT, BALP and/or bone scan)
- History/physical examination with digital rectal examination and baseline toxicity assessment within 90 days prior to study registration
Exclusion Criteria
- Pathologic T1 tumors (AJCC Criteria 8th Ed.) tumors
- Evidence of distant metastasis or lymph node involvement pathologically or on imaging. If confirmatory imaging studies remain equivocal, the patient is excluded unless biopsy of the questionable area is negative
- Prior systemic chemotherapy for any reason
- Previous irradiation to the pelvis that would compromise the ability to deliver the prescribed study treatment (per treating physician discretion)
- Active inflammatory bowel disease (Crohn’s disease, diverticulitis or ulcerative colitis) affecting the rectum. (Non-active diverticulitis and Crohn’s disease not affecting the rectum are allowed)
- History of hip replacement
- Prior or concurrent cancer, other than non-melanomatous skin cancer, unless disease free for at least 5 years
- Taking Saw Palmetto or methotrexate and unable or unwilling to discontinue its use during radiation
- History of proximal urethral stricture requiring dilatation
- 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
Additional locations may be listed on ClinicalTrials.gov for NCT00969111.
Locations matching your search criteria
United States
Florida
Jacksonville
Illinois
DeKalb
Geneva
Warrenville
PRIMARY OBJECTIVE:
I. Collect and analyze morbidity outcomes.
SECONDARY OBJECTIVES:
I. Collect and analyze quality of life, disease control and survival outcome parameters.
II. Collect and analyze treatment, biologic and diagnostic information that may impact quality of life, disease control, morbidity and survival outcomes.
III. Collect and analyze tumor control outcomes via:
IIIa. Physical examination;
IIIb. Biochemical response rate via prostate-specific antigen (PSA) monitoring;
IIIc. Progression free survival rate;
IIId. Median survival rate;
IIIe. Disease-free survival rate;
IIIf. One year overall survival rate.
OUTLINE: Patients are assigned to 1 of 4 groups.
GROUP I: Patients with non-high risk prostate cancer undergo postoperative proton beam radiation therapy (PBRT) over 5 fractions on study. Patients may receive androgen therapy with goserelin subcutaneously (SC), triptorelin intramuscularly (IM), or leuprolide SC or IM once a month or once every 3 months. Patients may undergo chest X-ray and bone scan during screening. Patients also undergo computed tomography (CT) and/or magnetic resonance imaging (MRI) throughout the study.
GROUP II: Patients with high risk prostate cancer undergo postoperative intensity modulated radiation therapy (IMRT) over 5 fractions on study. Patients may receive androgen therapy with goserelin SC, triptorelin IM or leuprolide SC or IM once a month or once every 3 months. Patients may undergo chest X-ray and bone scan during screening. Patients also undergo CT and/or MRI throughout the study.
GROUP III: Patients with non-high risk prostate cancer undergo salvage PBRT over 5 fractions on study. Patients may receive androgen therapy with goserelin SC, triptorelin IM or leuprolide SC or IM once a month or once every 3 months. Patients may undergo chest X-ray and bone scan during screening. Patients also undergo CT and/or MRI throughout the study.
GROUP IV: Patients with high risk prostate cancer undergo IMRT over 5 fractions on study. Patients may receive androgen therapy with goserelin SC, triptorelin IM or leuprolide SC or IM once a month or once every 3 months. Patients may undergo chest X-ray and bone scan during screening. Patients also undergo CT and/or MRI throughout the study.
After completion of study treatment, patients are followed up at 3, 6, 12, 18, 24, 36, 48, and 60 months and every 2 years thereafter.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationUniversity of Florida Proton Therapy Institute
Principal InvestigatorSamuel Jean-Baptiste
- Primary IDGU010-18
- Secondary IDsNCI-2023-08554, IRB201800398, OCR10959
- ClinicalTrials.gov IDNCT00969111