Rochester, MNNCT07650240Now EnrollingIRB Ready

Recurrent Prostate Adenocarcinoma Clinical Trial in Rochester, MN

Access cutting-edge recurrent prostate adenocarcinoma treatment through this phase 2 clinical trial at a research site in Rochester. Study-provided care at no cost to qualified participants.

Sponsored by Mayo Clinic

Quick Self-Assessment

See if you qualify for this Rochester location

Preparing your pre-screening questions…

Expert Care in Rochester

Access recurrent prostate adenocarcinoma specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related recurrent prostate adenocarcinoma treatment provided free

Apply for This Rochester Location

Check if you qualify for this recurrent prostate adenocarcinoma clinical trial in Rochester, MN

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Rochester

    Convenient for MN residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Rochester site if eligible
  4. 4Begin participation

About This Recurrent Prostate Adenocarcinoma Study in Rochester

This phase II trial tests leuprolide acetate alone versus in combination with 177Lu-PSMA-617, with or without abiraterone acetate and prednisone, for the treatment of hormone-sensitive prostate cancer has spread to a limited number of anatomic sites at the time of initial diagnosis (de novo low volume metastasis) or that has come back after a period of improvement (recurrent). Standard of care treatment for prostate cancer usually includes androgen deprivation therapy, with or without abiraterone acetate and prednisone. Leuprolide acetate is a form of androgen deprivation therapy. It blocks the body from making testosterone (a male hormone) and estradiol (a female hormone). It may stop the growth of prostate cancer cells that need testosterone to grow. 177Lu-PSMA-617 is a type of radioconjugate drug. Upon administration, vipivotide tetraxetan targets and binds to prostate specific membrane antigen (PSMA)-expressing tumor cells. Upon binding, PSMA-expressing tumor cells are destroyed by 177Lu through the specific delivery of radiation. PSMA, a tumor-associated antigen and type II transmembrane protein, is overexpressed on prostate tumor cells. Abiraterone acetate is a type of anti-androgen drug. It blocks tissues from making androgens (male hormones), such as testosterone. This may cause the death of cancer cells that need androgens to grow. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Giving 177Lu-PSMA-617 in combination with leuprolide acetate, with or without abiraterone acetate and prednisone, may be more effective at treating patients with recurrent or de novo low volume metastatic hormone-sensitive prostate cancer than giving leuprolide acetate alone.

Sponsor: Mayo Clinic

Who Can Participate

Inclusion Criteria

Male patients aged 18 years or older
Signed informed consent must be obtained prior to participation in the study
Histologically confirmed adenocarcinoma of the prostate
Prior treatment with radical prostatectomy or radiation therapy for localized disease is required
Prior treatment with ADT or androgen receptor pathway inhibitor (ARPI) or cytotoxic chemotherapy is permitted if:
The last treatment \> 12 months from enrollment on the trial
The duration of treatment is less than 3 months and no evidence of disease progression on treatment
Disease detected on PSMA PET/CT scan \[PSMA-avid low volume metastasis (LVM)\]. Patients with standardized uptake value maximum (SUVMax) lesion/liver \>1 \[molecular imaging PSMA (miPSMA) score of 2\] or lesion/parotid \> 1 (miPSMA score of 3) would be included. PET scanners used in the study will comply with current guidelines established by the European Association of Nuclear Medicine (EANM) Research Limited (Ltd) (EARL) for harmonizing PET/CT image acquisition and reconstruction
Patients with hormone sensitive low volume metastatic disease (LVM); either de novo metastatic or recurrent disease. LVM, as assessed on PSMA PET/CT is defined as:
=\< 10 total metastatic spots
Lymph nodes with short axis of =\< 2.5 cm
Total tumor volume (TTV) \< 200 mL
=\< 4 bone metastases
No brain or liver metastases
Eastern Cooperative Oncology Group (ECOG) performance 0 - 2
Hemoglobin \>= 9 g/dL
Platelet count \>= 100,000/mm\^3
Absolute neutrophil count \>= 1,500/mm\^3
Serum bilirubin =\< 1.5 x upper limit of normal (ULN)
Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) =\< 2.5 x ULN
Serum creatinine =\< 1.5 x ULN or an estimated glomerular filtration rate (eGFR) \>= 50 mL/min/1.73m\^2
Able to start therapy within 28 days of screening
Expected life expectancy \> 6 months

Exclusion Criteria

PSMA-undetectable disease defined as rising prostate specific antigen (PSA) with absence of PSMA-positive lesions in PSMA PET/CT imaging
PSMA-negative disease defined as lesions detected on imaging that are deemed concerning for active cancer metastasis with PSMA SUVmax less than liver and meeting specific size criteria: lymph nodes with short axis of \>= 2.5 cm, visceral lesions with a solid appearance (soft tissue density) \>= 1 cm, and bone metastases with a measurable soft tissue component \>= 1 cm
Patient with in-field failure (disease recurrence in prostate bed after primary definitive prostatectomy or radiotherapy)
Patient with spinal metastatic disease-causing cord compression
Patient with prior disease progression on ADT \[castration resistance prostate cancer (CRPC)\]
Prior treatment with ADT or cytotoxic chemotherapy or ARPI within less than 12 months from enrollment on the trial
Prior treatment with ADT or ARPI or cytotoxic chemotherapy is permitted only if more than 3 months treatment duration and no evidence of disease progression on treatment
Patients with severe \[Common Terminology Criteria for Adverse Events (CTCAE) grade \> 2\] xerostomia
Patients with well documented history of myelosuppression or renal disease that might impair their participation in the trial per medical advice
Diagnosed with other malignancies that are expected to alter life expectancy or may interfere with disease assessment. However, participants with a prior history of malignancy that has been adequately treated non-melanoma skin cancer, superficial bladder cancer are eligible
Estimated life expectancy \< 6 months
Concurrent serious medical co-morbidities as determined by study investigator and expected to impair participation in the study
Subjects with female partners of reproductive potential are required to use effective, medically acceptable methods of birth control (e.g., spermicide in conjunction with a barrier such as a condom or sexual abstinence) while on this study, and for 14 weeks after the last dose of 177Lu-PSMA-617

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Rochester?

Yes, this clinical trial (NCT07650240) has an active research site in Rochester, MN that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Recurrent Prostate Adenocarcinoma Treatment Options in Rochester, MN

If you're searching for recurrent prostate adenocarcinoma treatment options in Rochester, MN, this clinical trial (NCT07650240) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Rochester research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced recurrent prostate adenocarcinoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all recurrent prostate adenocarcinoma clinical trials near you to find additional studies recruiting in your area.

More Prostate Cancer Trials in Rochester, MN

See all prostate cancer clinical trials recruiting in Rochester — not just this study.

Browse Prostate Cancer Trials in Rochester →

Browse More Trials by Condition

Prostate Cancer TrialsAlzheimers Disease TrialsAtopic Dermatitis TrialsAll Conditions →

Ready to Join in Rochester?

Take the first step toward participating in this groundbreaking clinical trial

Secure · Expert Care · Rochester, MN