Postoperative or Salvage Radiotherapy for Node Negative Prostate Cancer Following Radical Prostatectomy

The main purpose of the study is to test whether trilaciclib can protect the bone marrow (where the cells used to fight infection, carry oxygen and clot blood are made) from damage by chemotherapy.

The study will also test whether participants receiving trilaciclib feel less tired during chemotherapy and how long the chemotherapy keeps the colorectal cancer under control in participants receiving trilaciclib compared with those who do not receive trilaciclib.

Age Group Specifics: males older than 18 years old.

Inova Schar Cancer Institute
8081 Innovation Park Drive
Fairfax, VA 22031

A department of Inova Fairfax Hospital

• Age ≥ 18 years. Pathologically confirmed adenocarcinoma of the prostate treated primarily with open, laparoscopic, or robotically assisted prostatectomy
• Pathological stage T2a-T3b N0 M0 (AJCC Criteria 8th Ed.) adenocarcinoma of the prostate
• Maximum 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 to <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
• 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
• Additional eligibility in protocol.

• Pathologic T1 (AJCC Criteria 8th Ed.) tumors
• Evidence of distant metastasis (M1). 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
• Patients from outside of the United States may participate in the study. Enrollment and treatment must be completed at an approved PCG member institution in the United States
• Additional ineligibility in protocol

Additional information can be found at: https://clinicaltrials.gov/ct2/show/ NCT00969111