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Stage I Prostate Cancer AJCC v8Early Phase 1NCT04288336

Daily, Long-Term Intermittent Fasting for the Prevention of PSA-Recurrence in Patients With Localized Prostate Cancer After Radical Prostatectomy

A Early Phase 1 study testing Food Diary, Preventative Dietary Intervention and Questionnaire Administration in people with Stage I Prostate Cancer AJCC v8 and Stage II Prostate Cancer AJCC v8, run by Mayo Clinic at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This early phase I trial studies the feasibility of a daily, long-term intermittent fasting routine in preventing or delaying a rise in prostate specific antigen (PSA) levels in patients with prostate cancer that has not spread to other parts of the body (localized) and who have undergone radical prostatectomy. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Food Diary, Preventative Dietary Intervention and Questionnaire Administration
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
8 Jan 2020to 25 Mar 2022
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Biopsy-proven histological diagnosis of localized prostate cancer (pT2 or specimen confined pT3)
  • Having undergone radical prostatectomy (open or laparoscopic) with bilateral pelvic lymph node dissection
  • Negative surgical margins on final specimen
  • Men that decline adjuvant therapy
  • Detectable serum PSA of 0.1 ng/mL or >
  • 24 months or less since radical prostatectomy at time of study screening

Who cannot join

  • Unable or unwilling to provide informed consent
  • Treated prior to surgery with any form of hormone, antiandrogen, or androgen deprivation therapy
  • Treated prior to surgery with any form of chemotherapy or radiotherapy
  • Medical conditions/history that precludes subjects from following a fasting regimen, including but not limited to:
  • Diabetes mellitus
  • On hormone therapy (Casodex, gonadotrophin releasing hormone [GnRH] agonist/antagonist)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mayo Clinic

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: A Prospective Pilot Study Evaluating the Feasibility of Daily, Long-Term Intermittent Fasting for Men on PSA Surveillance Following Radical Prostatectomy for Localized, High-Risk Prostate Cancer

This early phase I trial studies the feasibility of a daily, long-term intermittent fasting routine in preventing or delaying a rise in prostate specific antigen (PSA) levels in patients with prostate cancer that has not spread to other parts of the body (localized) and who have undergone radical prostatectomy. PSA is a protein produced by both normal and cancer cells. Following a daily fasting routine after treatment for prostate cancer may lower the risk of patients' PSA level rising above 0.4 ng/mL, which is also called PSA-recurrence. A PSA-recurrence can sometimes mean that the disease has returned and/or progressed.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine whether men treated for localized prostate cancer adhere to a long-term (months-years) daily intermittent fasting regimen.

II. To measure the levels of metabolic and prostate-cancer derived microparticles in the serum of men that practice a daily intermittent fasting regimen after treatment for localized, high-risk prostate cancer.

OUTLINE:

Beginning when patients' PSA is detectable up to 24 months after surgery, patients follow a daily intermittent fasting routine consisting of restricting the daily eating period to 8 hours (e.g. between 1PM-9PM) followed by 16 hours of prolonged nightly fasting for up to 1 year or until secondary therapy commences.

Being tested
Food Diary, Preventative Dietary Intervention, Questionnaire Administration
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Food DiaryOther

    Ancillary studies

  • Preventative Dietary InterventionOther

    Follow intermittent fasting

  • Questionnaire AdministrationOther

    Ancillary studies

Study groups in NCT04288336
Study groupRoleWhat they receive
Prevention (intermittent fasting)ExperimentalBeginning when patients' PSA is detectable up to 24 months after surgery, patients follow a daily intermittent fasting routine consisting of restricting the daily eating period to 8 hours (e.g. between 1PM-9PM) followed by 16 hours of prolonged nightly fasting for up to 1 year or until secondary therapy commences.
Receives: Other: Food Diary; Other: Preventative Dietary Intervention; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adherence to the daily intermittent fasting regimen

    Will be assessed via the phone surveys conducted at each remote follow up visit, as well as through analysis of the subjects' daily journals that will be sent back to the study team at the end of the study period.

    Measured: Up to 1 year

Secondary outcomes (1)

  1. Prostate specific antigen (PSA) kinetics and/or doubling time

    Will assess the PSA kinetics and/or doubling time as it relates to historical patients whom have also undergone PSA surveillance with postoperative PSA detection 0.1 or >.

    Measured: Up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2020
  2. Study start8 Jan 2020
  3. Primary completion25 Mar 2022
  4. Study completion25 Mar 2022

Why it stopped: No patient accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04288336
Sponsor's protocol ID
19-006675
Other IDs
NCI-2020-00832, MC2052, 19-006675, P30CA015083
Status last verified
Jul 2022
First submitted
26 Feb 2020
Last updated
11 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Food Diary, Preventative Dietary Intervention and Questionnaire Administration in people with Stage I Prostate Cancer AJCC v8 and Stage II Prostate Cancer AJCC v8, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 11 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adherence to the daily intermittent fasting regimen (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04288336.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2022.

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