RightFit
Not yet recruitingEarly Phase 1

Response With Interim PSMA PET in Metastatic Castration-sensitive Prostate Cancer for Optimization of Adaptive Metastasis-directed Radiotherapy Delivery

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 3 months

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "All participants will undergo standard of care systemic therapy, including ADT and androgen receptor signaling inhibitors intensification as clinically indicated, for up to three months before protocol radiotherapy."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

The purpose of this study is to characterize the reduction in PSMA-avid tumor volume and metastasis-directed radiotherapy treatment intensity facilitated by PET PSMA-response adapted SABR for poly-metastatic castration sensitive prostate cancer.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

Inclusion Criteria: 1. History of pathologically confirmed prostate cancer. 2. Age \>=18 years. 3. Performance status ECOG 0-2. 4. Staging 68Ga PMSA-11 PET/CT showing 4-20 sites of metastasis from prostate cancer within \<=90 days prior to registration. This scan ideally should be performed before initiation of androgen deprivation therapy (ADT). 5. At the discretion of the treating investigator, it is believed that it is safe to treat all sites of disease using SABR. 6. All men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of standard of care SABR and for a period of time of 6 months thereafter as per standard guidelines. Should a patient's partner become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. 7. Ability to understand and the willingness to sign a written informed consent. 8. Planned for standard systemic therapy for metastatic prostate cancer to include androgen deprivation therapy (ADT). Upfront Docetaxel should not be planned (See section 4.1.2). Exclusion Criteria: 1. Prior radiotherapy to any metastases currently targeted for therapy or overlapping regions. 2. Patient with metastatic lesions involving the gastrointestinal tract, specifically, invading esophagus, stomach, or intestines will be excluded. Patients with ultra-central metastatic lesions defined as 1 cm from the trachea and main bronchi will be excluded. 3. Serious medical co-morbidities precluding safe delivering of radiotherapy to poly-metastatic sites. This includes interstitial lung disease for patients undergoing SABR to thoracic sites and ulcerative colitis or Crohn's disease requiring systemic immunosuppressive therapy for patients undergoing SABR to GI sites. 4. Subjects may not be receiving any other PSMA-directed investigational agents for the treatment of the cancer under study. 5. History of allergic reactions to PMSA-11 68Ga imaging agent. 6. Uncontrolled intercurrent illness or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements.

Study sites (1)

TX