Prostate SBRT for Locally Recurrent Prostate Cancer After Prior Radiotherapy

• ClinicalTrials.gov Identifier: NCT03253744
• Recruitment Status: Recruiting
• First Posted: August 18, 2017
• Last Update Posted: July 16, 2019
• Sponsor: National Cancer Institute (NCI)
• Information provided by (Responsible Party): National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Tracking Information

• First Submitted Date: August 17, 2017
• First Posted Date: August 18, 2017
• Last Update Posted Date: July 16, 2019
• Actual Study Start Date: July 5, 2018
• Estimated Primary Completion Date: June 20, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 13, 2018)

Maximum tolerated dose [ Time Frame: 3 weeks post-treatment ]

Define the MTD of imageguided, focally dose escalated prostate SBRT in patients with a local recurrence of prostate cancer after priorradiotherapy.

• Original Primary Outcome Measures (submitted: August 17, 2017): Maximum tolerated dose [ Time Frame: 3 weeks post-treatment ]
• Change History: Complete list of historical versions of study NCT03253744 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: August 17, 2017)

• Assessment of Dose limiting toxicities [ Time Frame: 3 weeks after end of treatment ]
• biochemical progression free survival [ Time Frame: 1 and 2 years after treamtnet ]
• Changes of quality of life scores during and after treatment [ Time Frame: 2 years after treatment ]
• Sensitivity and specifity of 18FDCFPyl imaging as compared tobiopsy in detecting locally recurrent prostate cancer [ Time Frame: 6 months after radiation ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Prostate SBRT for Locally Recurrent Prostate Cancer After Prior Radiotherapy
• Official Title: Phase I Trial of Image Guided Focally Dose Escalated Prostate SBRT for Locally Recurrent Prostate Cancer After Prior Radiotherapy

Brief Summary

Background:

Prostate cancer is the second leading cause of cancer death in U.S. men. Radiation is an effective treatment for most patients with localized prostate cancer, but sometimes the tumor returns. Researchers want to see if a highly focused type of radiation can help. It is given in only 5 treatments. It is called stereotactic body radiation therapy (SBRT).

Objective:

To study the maximum tolerated dose and side effects of stereotactic body radiation therapy in people with a local recurrence of prostate cancer after radiation.

Eligibility:

Men at least 18 years old who have recurrent prostate cancer after radiation therapy and no evidence of distant metastatic disease

Design:

Participants will be screened with blood tests, physical exam, and medical history. They may also have:

Magnetic resonance imaging (MRI) scan of the prostate..

PET/CT scan. Participants will get an injection of 18F-DCFPyL for the PET scan. They will lie very still on their back on the scanner table.

Small samples of prostate tumor tissue will be taken by a needle through the skin or rectum to see if the cancer is in the prostate. Small metal seeds will be placed into the prostate at the same time to help guide the radiation.

About 2 weeks later, participants will have a radiation treatment planning CT scan.

Participants will answer questions about their urine function, bowel function, erectile function, and mood.

Participants will receive SBRT. They will have 5 radiation treatments over 2 weeks.

Participants will have follow-up visits. They will have a physical exam, blood tests, and questionnaires.

Six months after ending SBRT, the 18F-DCFPyL PET/CT will be repeated....

Detailed Description

Background:

Prostate cancer that recurs after prior radiation treatment can be challenging to cure due to the side effects of available treatments such as surgery and cryoablation. Re-irradiation with brachytherapy or stereotactic approaches has shown excellent rates of prostate cancer disease control with tolerable side effects. Using image guidance to allow highly conformal focal reirradiation may potentially increase the efficacy of re-irradiation.

Objectives:

-Define the maximum tolerated dose (MTD) of image guided, focally dose escalated prostate radiation with stereotactic body radiation therapy (SBRT) in patients with a local recurrence of prostate cancer after prior radiotherapy.

Eligibility:

• Histological confirmation of recurrent prostate cancer after prior irradiation (external beam or brachytherapy)
• No evidence of distant metastases of prostate cancer
• No prior prostatectomy
• Subject is greater than or equal to18 years old
• ECOG performance status less than or equal to 2 (Karnofsky greater than or equal to 60%).

Design:

This is a Phase I trial of focal dose escalation with SBRT using image and pathologic guidance. Areas in the prostate shown to have tumor on biopsy or with advanced imaging studies will be treated with highly conformal SBRT over a period of two to three weeks. Treatment will be guided and gated by fiducials implanted in the prostate. Patients will be treated to escalating doses based on tolerability of the treatment. Quality of life and functional outcomes such as urine, bowel, and erectile function will be assessed with questionnaires. Up to 52 patients will be enrolled.

• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Non-Randomized; Intervention Model: Sequential Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Prostate Cancer
• Prosatatic Neoplasm

Intervention

• Drug: 18F-DCFPyL
  Subjects will receive 18F-DCFPyL at baseline and 6 months after radiation. The maximum amount of injected active drug will be less than 4.02 micrograms. The target administered activity will be 10 mCi.
• Radiation: Tumor Irradiation
  SBRT will be delivered to areas of recurrent prostate cancer identified on imaging and biopsy
• Radiation: Prostate radiation + tumor boost irradiation
  SBRT will be delivered to areas of recurrent prostate cancer identified on imaging and biopsy; and a reduced dose will be delivered to the entire prostate

Study Arms

• Experimental: 1/Tumor Irradiation
  SBRT will be delivered to areas of recurrent prostatecancer identified on imaging and biopsy
  Interventions:

  • Drug: 18F-DCFPyL
  • Radiation: Tumor Irradiation
• Experimental: 2/Prostate and Tumor Irradiation
  SBRT will be delivered to areas of recurrent prostatecancer identified on imaging and biopsy; and a reduced dose will be delivered to the entire prostate
  Interventions:

  • Drug: 18F-DCFPyL
  • Radiation: Prostate radiation + tumor boost irradiation

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: August 17, 2017): 52
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 20, 2021
• Estimated Primary Completion Date: June 20, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

• INCLUSION CRITERIA:
• Patients must have histologically confirmed locally recurrent adenocarcinoma of the prostate after prior radiation (EBRT or brachytherapy).
• PSA failure after definitive radiation as defined by the Phoenix criteria (PSA elevation at least 2 ng/dL above post-radiotherapy nadir)
• Age greater than or equal to 18 years.
• ECOG performance status less than or equal to 2 (Karnofsky greater than or equal to 60%).
• Ability of subject to understand and the willingness to sign a written informed consent document.

EXCLUSION CRITERIA:

• Patients who are receiving any other investigational agents.
• PSA greater than or equal to 20 ng/dL if no prior DCFPyL scan obtained (If PSA > 20 and DCFPyL obtained within 3 months prior to enrollment shows no evidence of metastatic disease, subjects may be included in the study)
• Biochemical recurrence within one year of completion of radiotherapy
• Need for chronic anticoagulation therapy (chronic low dose aspirin is not an exclusion)
• Pre-existing and ongoing radiation-related grade 3 bowel or bladder toxicity
• Inflammatory bowel disease
• Active Lupus or Active scleroderma
• Patients with distant metastatic disease (prostate adjacent adenopathy is not an exclusion)
• Prior prostatectomy
• Subjects with any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or results.
• Subjects with severe claustrophobia that is unresponsive to oral anxiolytics
• Other medical conditions deemed by the Principal Investigator (or associates) to make the subject unsafe or ineligible for protocol procedures
• Subjects weighing > 350 lbs. (weight limit for scanner table), or unable to fit within the imaging gantry
• Serum creatinine > 2 times the upper limit of normal
• Total bilirubin > 2 times the upper limit of normal OR in patients with Gilbert s syndrome, a total bilirubin > 3.0.
• Liver transaminases (ALT, AST) greater than 3 times the upper limit of normal
• Patients with positive Human Immunodeficiency Virus (HIV) status and currently requiring treatment with agents known to sensitize to irradiation, such as protease inhibitors, will be excluded

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Theresa Cooley-Zgela, R.N.; (301) 451-8905; theresa.cooleyzgela@nih.gov

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03253744
• Other Study ID Numbers: 170153; 17-C-0153
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Responsible Party: National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
• Study Sponsor: National Cancer Institute (NCI)
• Collaborators: Not Provided

Investigators

• Principal Investigator: Deborah E Citrin, M.D.; National Cancer Institute (NCI)

• PRS Account: National Institutes of Health Clinical Center (CC)
• Verification Date: May 30, 2019