
Selecting and Setting Up your Advanced Prostate Cancer Trial (2025)
Selecting and Setting Up your Advanced Prostate Cancer Trial
This webinar series was developed in support of the objectives of the AUA Clinical Trials CollectiveTM.
With the wide array of actively enrolling and forthcoming clinical trials for the treatment of advanced prostate cancer available to providers and patients, urologists newly or recently embarking on clinical trial research must be equipped with the skills to optimally select appropriate trials for implementation. This webinar explores the critical questions that determine what makes a trial ideal, or suboptimal, for urology program and patient populations they serve. Elements such as trial feasibility assessment, budgeting and negotiating, industry partnership, review board navigation, financial management, and protocol fundamentals will be discussed in this virtual educational activity, essential to all urologists considering enhancing their clinical practice with clinical trial research engagement.
Acknowledgements:
Support provided by an endowment from Chesapeake Urology Associates.
About the AUA Clinical Trials Collective™
The AUA Clinical Trials Collective™ (AUACTC™) was formed in 2024. The mission of the AUACTC™ is to address and overcome the challenges faced by clinical trials. This activity was developed in support of the educational needs identified by the AUACTC™.
Target Audience
This continuing medical education activity was designed for:
- Residents/Fellows
- Urologists
- Clinical Research Coordinators
- Other Healthcare Professionals
Learning Objectives
After participating in this CME activity, participants will be able to:
- Interpret the principles of designing and implementing feasibility assessments to match trial protocols with typical patient population, site capabilities, and strategic goals.
- Strategically develop clinical trial budgets and navigate contract negotiation in partnership with trial sponsors.
- Navigate institutional review broad processes and requirements to effectively implement and maintain desired clinical trial activation and enrollment timelines.
- Initiate essential operational steps for trial startup, including staff training, protocol review, and site initiation.
Welcome and Introductions
Segment 1: Feasibility and Trial Selection
Segment 2: Budgeting and Negotiating
Segment 3: Working with Industry
Segment 4: What's a CRO?
Segment 5: Institutional and Regulatory Readiness (Central vs. local IRB)
Segment 6: Budgeting and Financial Feasibility
Segment 7: Operational Startup
Segment 8: Protocol Fundamentals
Wrap-up
| Name | Company Name | Relationship Type | End Date |
| Lowentritt, Benjamin Hugh | Janssen | Consultant or Advisor | Current |
| Bayer | Consultant or Advisor | Current | |
| Dendreon | Consultant or Advisor | Current | |
| Astellas | Consultant or Advisor | Current | |
| Pfizer | Consultant or Advisor | Current | |
| Merck | Consultant or Advisor | Current | |
| BlueEarth Diagnostics | Consultant or Advisor | Current | |
| Astra Zeneca | Consultant or Advisor | Current | |
| Sumitomo Pharma | Consultant or Advisor | Current | |
| Novartis | Scientific Study or Trial | Current | |
| Morgan, Todd Matthew | Foundation Medicine | Consultant or Advisor | Current |
| Merck | Consultant or Advisor | Current | |
| Morris, David | Astellas | Consultant or Advisor | Current |
| Janssen | Consultant or Advisor | Current | |
| Bayer | Consultant or Advisor | Current | |
| Myriad | Consultant or Advisor | Current | |
| UroGen | Consultant or Advisor | Current | |
| Astra Zeneca | Consultant or Advisor | Current | |
| Merck | Consultant or Advisor | Current | |
| Decipher Bio | Consultant or Advisor | Current | |
| Tolmar | Consultant or Advisor | Current | |
| Myovant | Consultant or Advisor | Current | |
| Pfizer | Meeting Participant or Lecturer | Current | |
| Lantheus | Consultant or Advisor | Current | |
| Blue Earth Diagnostics | Consultant or Advisor | Current | |
| Dendreon | Consultant or Advisor | Current | |
| Cleveland Diagnostics | Consultant or Advisor | Current | |
| Verity | Consultant or Advisor | Current | |
| Caris Diagnostics | Consultant or Advisor | Current | |
| Telix | Consultant or Advisor | Current | |
| Clarity | Scientific Study or Trial | Current |
Research Education, Conferences, and Communications Committee (RECCC) Disclosures:
Conflict of Interest Review Work Group Disclosures:
COI Review Workgroup DTL 2025.pdf
AUA Office of Research Staff has nothing to disclose.
All relevant financial relationships have been mitigated.
AUA ACCREDITATION INFORMATION
Accreditation: The American Urological Association (AUA) is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.
Credit Designation: The American Urological Association designates this live activity for a maximum of 1.0 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Other Learners: The AUA is not accredited to offer credit to participants who are not MDs or DOs. However, the AUA will issue documentation of participation that states that the activity was certified for AMA PRA Category 1 Credit™.
Evidence Based Content: It is the policy of the AUA to ensure that the content contained in this CME activity is valid, fair, balanced, scientifically rigorous, and free of commercial bias.
AUA Disclosure Policy: All persons in a position to control the content of a CME activity are required to disclose to the AUA, as the ACCME-accredited provider, all financial relationships with any ineligible company (formerly commercial interests) during the previous 24 months. An ineligible company is defined as one whose primary business is producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients. The AUA must determine if the individual’s relationships are relevant to the educational content and mitigate any conflicts of interest prior to the commencement of the educational activity. The intent of this disclosure is not to prevent individuals with relevant financial relationships from participating, but rather to provide learners with information so they can make their own judgments.
Mitigation of Identified Conflict of Interest: All disclosures will be reviewed by the AUA Conflict of Interest (COI) Review Work Group Chair and/or Vice Chair for identification of relevant financial relationships that result in conflicts of interest. The AUA COI Review Work Group, working with Office of Education staff, will document the mechanism(s) for management and mitigation of the conflict of interest and final approval of the activity will be documented prior to implementation.
Off-label or Unapproved Use of Drugs or Devices: The audience is advised that this continuing medical education activity may contain reference(s) to off-label or unapproved uses of drugs or devices. Please consult the prescribing information for full disclosure of approved uses.
Available Credit
- 1.00 AMA PRA Category 1 Credit™
- 1.00 Non-Physician Participation
Registration for Selecting and Setting Up your Advanced Prostate Cancer Trial (2025) is complimentary, however should you need to cancel your participation for any reason, please let us know at least two weeks before the course by contacting [email protected].
To join the live virtual course:
- Click on the TAKE COURSE button.
- Click “Live Virtual Course” in the Course Progress pane.
- Click the link to register in advance.
- After registering, you will receive a confirmation email containing information about joining the live virtual course.
Attendee Information & Policies
AUA Anti-Harassment Policy
AUA Commitment: AUA is committed to providing a safe and productive meeting environment that fosters open dialogue and the exchange of scientific ideas and is free of harassment and discrimination. All meeting participants are expected to behave professionally and treat others with respect, follow venue rules, and alert AUA staff or security of any dangerous situations or anyone in distress.
Reporting Harassment: It is the policy of the AUA that all meeting participants will enjoy an environment free from discrimination, harassment or retaliation. Harassing behavior by meeting participants will not be tolerated. If an individual experiences or witnesses harassment, he or she should contact Janet Skorepa, AUA EVP, at [email protected] or Maureen E. Cones, Esq., AUA General Counsel, at [email protected] or use a venue phone and ask for security if he or she feels unsafe. All complaints will be treated seriously and responded to promptly.
The AUA reserves the right to take any action deemed necessary and appropriate, including refusing or revoking the registration of any individual, without refund, as long as such refusal is consistent with applicable law and AUA policy.
Disclaimer: The opinions and recommendations expressed by faculty, authors and other experts whose input is included in this program are their own and do not necessarily represent the viewpoint of the American Urological Association (AUA).
Consent to Use of Photographic Images: Registration and attendance at or participation in AUA meetings and other activities constitutes an agreement by the registrant to AUA's use and distribution (both now and in the future) of the registrant or attendee's image or voice in photographs, videotapes, electronic reproductions, and audiotapes of such events and activities.
Audio, Video, Photographic Equipment: The use of audio, video and other photographic recording equipment by attendees is prohibited inside AUA meeting rooms.
Reproduction Permission: Reproduction of written materials developed for this AUA course is prohibited without the written permission from individual authors and the AUA.
Special Assistance/Dietary Needs: The AUA complies with the Americans with Disabilities Act §12112(a). If any participant is in need of special assistance or has any dietary restrictions, a written request should be submitted at least one month in advance. For additional assistance with your request please call 1-800-908-9414.

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