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Recurrent Prostate Cancer After SurgeryPhase 2DASBRT-RPCNCT05946824

This Study is Evaluating a New Radiation Treatment Technique for Patients Who Have Had Prostate Cancer, Undergone Surgery for Cancer, and Then Have Evidence That Their Prostate Cancer Has Returned.

A Phase 2 study testing Daily-adaptive Stereotactic Body Radiation Therapy in people with Recurrent Prostate Cancer After Surgery, run by University of Rochester at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

There is significant, proven use of radiation for recurrent prostate cancer after surgical resection. This treatment typically is delivered over seven and a half weeks of daily treatments, presenting a burden to patients and the health care system. Read more about this study

Who is it for?
Ages 18 years and older, men onlyHealthy volunteers can take part
Conditions the study is for
Recurrent Prostate Cancer After Surgery
What is being tested?
Daily-adaptive Stereotactic Body Radiation Therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteUnited States
Study dates
14 Dec 2023to 24 Nov 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Adenocarcinoma of the prostate with previous surgical resection
  • Radiologically detected prostate bed OR regional nodal recurrence defined as iliac, obturator, perirectal or pre-sacral node generally encompassing below the aortic bifurcation
  • Prostate bed recurrence as occurring within the region of the prostate or RTOG consensus definition of the surgical field
  • At least two serum detectable PSA levels defined as >0.02 ng/dl at least 30 days apart.

Who cannot join

  • Metastatic disease
  • Prior radiation therapy to the pelvis region
  • Inflammatory bowel disease
  • Hospitalization for a gastrointestinal diagnosis in the preceeding 3 months
  • Hospitalization for a urinary tract issue / diagnosis in the preceeding 3 months
  • PSA >10 ng/dl at study entry,

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Michael Cummings, MD contact

585-275-5622

michael_cummings@urmc.rochester.edu

United States1 site, 1 recruiting

  • Wilmot Cancer Institute - Dept of Radiation Oncology

    Rochester, New York, 14624

    Michael Cummings, MD, 585-275-5622, michael_cummings@urmc.rochester.edu

    Michael Cummings, MD

    Recruiting

Other trials in United States

About this study

Official title: Daily-Adaptive Stereotactic Body Radiation Therapy for Biochemically Recurrent, Radiologic Apparent Prostate Cancer After Radical Prostatectomy

There is significant, proven use of radiation for recurrent prostate cancer after surgical resection. This treatment typically is delivered over seven and a half weeks of daily treatments, presenting a burden to patients and the health care system. Stereotactic body radiation (SBRT) is a radiation technique in which large doses are delivered over a short period of time. To date there is extremely limited evidence in SBRT for recurrent prostate cancer after surgery, with a significantly growing body of evidence for primary SBRT treatment of prostate cancer in men who opt for non-surgical upfront treatment. Additionally, advances in imaging have allowed better detection of the site of recurrence, and novel artificial intelligence aided daily-adaptive radiation therapy have allowed more precise delivery of radiation doses. This study seeks to evaluate the role of Daily-Adaptive with AI-assisted SBRT in the post operative setting utilizing Ethos Plan Adaptive technology in attempt to maintain control and minimize side effects.

Read the detailed description

This will be a two cohort Phase II single center, prospective trial, with a safety lead-in component. This design will allow an initial toxicity assessment phase of a novel radiation treatment schema that is based on other literature, but with limited evidence. There is no plan to escalate the dose. Pending assessment of the safety lead in, complete enrollment will be permitted. Each cohort will be analyzed separated for the safety lead in. There will be 7 patients in the safety lead in cohorts. The stopping point will be an incidence of 2 cases of CTCAE v5.0 Grade 3+ acute toxicity attributed to therapy within gastrointestinal or urinary domains. This generally entails symptoms significant enough to require a procedure or limit basic levels of daily activity (bathing, cooking). Actue toxicity of a comparable magnitude has been reported in the 1-5% rate in a recent meta-analysis of contemporary trials which utilized standard of care radiation. Thus two cases would represent an unacceptable increased toxicity level, and a cohort size of 7 is approximate the commonly accepted size in Phase I escalation studies to evaluate dose limiting toxicity.

Being tested
Daily-adaptive Stereotactic Body Radiation Therapy
Keywords
Stereotactic body radiation therapy, daily-adaptive radiation therapy, prostate cancer, recurrent prostate cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • Daily-adaptive Stereotactic Body Radiation TherapyRadiation

    Daily-adaptive radiation therapy to two dose levels - one to the area of radiologic recurrent nodal disease, and a lower, prophylactic dose to the standard post-prostatectomy and larger pelvic node fields

  • Daily-adaptive Stereotactic Body Radiation TherapyRadiation

    Daily-adaptive radiation therapy to two areas - a high dose to the area of radiologic recurrence, and a lower, prophylactic dose to the standard post-prostatectomy fields

Study groups in NCT05946824
Study groupRoleWhat they receive
1 - Prostate bed only recurrenceExperimentalPatients with confirmed radiologic recurrence of their prostate cancer in the defined region of the previous prostate surgery - commonly referred to as the prostate surgical bed.
Receives: Radiation: Daily-adaptive Stereotactic Body Radiation Therapy
2- Pelvic nodal with or without a prostate bed recurrenceExperimentalPatients who have a radiologic recurrence of prostate cancer in the pelvic node region
Receives: Radiation: Daily-adaptive Stereotactic Body Radiation Therapy

What is being measured

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

  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability])

    The Primary objective of the safety lead in component is to report acute, attributable genitourinary and gastrointestinal toxicity as scored by CTCAE v5.0.

    Measured: 1-2 years

  2. The primary objective of the full enrollment Phase II component is to report biochemical recurrence free survival (bPFS).

    We will utilize a globally standard definition of bPFS which was defined in the RADICALS(6) international trial as follows: freedom from PSA of 0·4 ng/mL or greater following postoperative radiotherapy, or PSA of more than 2·0 ng/mL at any time following therapy, clinical progression, or initiation of non-protocol hormone therapy, or death from any cause.

    Measured: 5 years

Secondary outcomes (3)

  1. Long term side effects

    Late patient toxicity as defined by EPIC-IPSS prostate QoL forms

    Measured: 5 years

  2. Distant metastasis free survival

    Development of metastatic prostate cancer to other parts of the body

    Measured: 5 years

  3. Need for long term anti-testosterone therapy

    Time to initiation of non-protocol hormonal therapy, if needed

    Measured: 5 years

Timeline

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

  1. First posted14 Jul 2023
  2. Study start14 Dec 2023
  3. Primary completion24 Nov 2025 (estimated)
  4. Study completion24 Nov 2028 (estimated)

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
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
This will be a two cohort Phase II single center, prospective trial, with a safety lead-in component. The cohorts will be defined by location of recurrence - either prostate bed alone, or a pelvic node with or without a prostate bed recurrence. This design will allow an initial toxicity assessment phase of a novel radiation treatment schema that is based on other literature, but with limited evidence. There is no plan to escalate the dose. Pending assessment of the safety lead in, complete enrollment will be permitted. Each cohort will be analyzed separated for the safety lead in.
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05946824
Sponsor's protocol ID
URGUP22037
Acronym
DASBRT-RPC
Status last verified
Oct 2024
First submitted
6 Jun 2023
Last updated
8 Oct 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Daily-adaptive Stereotactic Body Radiation Therapy in people with Recurrent Prostate Cancer After Surgery, run by University of Rochester 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 4 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: looking for participants now, as of the sponsor's last update on 8 Oct 2024. 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?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact Michael Cummings, MD (585-275-5622, michael_cummings@urmc.rochester.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) (time frame: 1-2 years). The study lists 2 primary outcomes in all. 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 NCT05946824.

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 8 Oct 2024.

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