Is NCT06084338 recruiting in Indianapolis, IN?

Yes, NCT06084338 is currently recruiting participants at its Indianapolis, IN location. This prostate cancer clinical trial is actively enrolling qualified participants.

How do I join the prostate cancer clinical trial in Indianapolis?

To join this clinical trial in Indianapolis, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Indianapolis clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Prostate Cancer Clinical Trial in Indianapolis, IN

About This Prostate Cancer Study in Indianapolis

This trial tests if the combination of comprehensive metastasis directed therapy delivered by a precision form of external beam radiotherapy (stereotactic ablative radiotherapy), combined with PSMA targeted radiopharmaceutical therapy and cessation of castration, and then followed by testosterone replacement, is an effective treatment for metastatic castration resistant prostate cancer. All patients will be treated with stereotactic ablative radiotherapy and PSMA targeted radiopharmaceutical th

Sponsor: VA Office of Research and Development

Who Can Participate

Inclusion Criteria

Subject must be 18 years of age or older at the time the Informed Consent is signed

The subject (or legally acceptable representative if applicable) must provide written informed consent for the trial

Pathologic diagnosis of prostate cancer of adenocarcinoma histology; presence small cell/neuroendocrine carcinoma is

Exclusion Criteria

Metastatic disease as documented by:

Osseous metastases detected by technetium-99m (99mTc) planar bone scan or NaF PET scan, or CT scan at some point in patient's history

Soft tissue metastases documented on CT or MRI

PSMA avid metastatic disease as determined by 18F-DCFPyL: at least one lesion with PSMA avidity greater than that of liver (see Prescribing Information for Pluvicto)

Progressive castration resistant prostate cancer as defined by serum testosterone \< 50 ng/mL and one of the following:

PSA progression confirmed per Prostate Cancer Clinical Trials Working Group (PCWG3)

Radiographic progression of soft tissues according to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) modified based on PCWG3, or radiographic progression of bone according to PCWG3

Prior use of a novel AR signaling inhibitor for 4 weeks, including abiraterone acetate plus prednisone/prednisolone, enzalutamide, apalutamide, and/or darolutamide NOTE: These AR signaling inhibitors may have been used for mCSPC, M0CRPC, and/or mCRPC.

ECOG PS grade of 0-2

10 metastases detectable on molecular imaging (PSMA and FDG PET) and amenable to SBRT

20% of metastases that are FDG avid but PSMA negative

Metastases that are not detectable on PSMA and FDG PET do not count toward the total number of metastases, as they are presumed to represent adequately treated sites of disease

Life expectancy 6 months

Adequate organ function:

Hemoglobin (hgb) \> 8.0 g/dL

Absolute neutrophil count (ANC) \> 1500/ µL

Platelets \> 75,000/ µL

Total bilirubin 1.5 x ULN OR direct bilirubin ULN for participants with total bilirubin levels \>1.5 x ULN

ALT and AST 3.0 x ULN ( 5 x ULN for participants with liver metastases) (Child-Pugh class A and B allowed; Child-Pugh class C is excluded)

Creatinine \< (2.0 mg/dL) during screening evaluation (\>2.0 is allowed if EGFR \>30 mL/min/1.73 m2)

Subject must agree to use contraception during the treatment period plus an additional 120 days after the last dose of study treatment and must refrain from donating sperm during this period Exclusion Criteria:

Visceral metastases including liver and brain (lung metastases are allowed)

Small cell/neuroendocrine carcinoma by hematoxylin and eosin light histology (immunohistochemical detection of rare/occasional cells that stain for neuroendocrine markers such as synaptophysin, neuron specific enolase, or chromogranin A is not sufficient to make a diagnosis of small cell/neuroendocrine carcinoma)

Anti-neoplastic therapies for prostate cancer must be completed \> 2 weeks prior to Day 1 (initiation of first dose of PSMA RLT)

Investigational agents must have been completed \> 4 weeks of Day 1 Note: Participants must have recovered from all AEs due to previous therapies to Grade 1 or baseline

Participants with Grade 2 neuropathy may be eligible

Herbal and non-herbal products that may decrease PSA levels other than medical castration and megestrol (up to 40 mg/day is allowed) for hot flashes

Has received prior radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.

If a subject has undergone major surgery, they must have recovered adequately from the toxicities or complications from the intervention within 4 weeks prior to starting therapy

History of non-prostate active malignancy requiring treatment in the 24 months prior to Day 1 except for non-muscle invasive urothelial cancer, non-melanoma skin cancer, or any cancer that in the opinion of the investigator has been adequately treated and will not interfere with study procedures or interpretation of results

Active infection or conditions requiring treatment with antibiotics

Symptomatic local recurrence in the setting of prior curative intent therapy (surgery and/or radiation to the prostate)

Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator

Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial

Subject is planning to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment

Current or impending cord compression or another indication for urgent palliative radiation therapy

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 Indianapolis?

Yes, this clinical trial (NCT06084338) has an active research site in Indianapolis, IN 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.

Prostate Cancer Treatment Options in Indianapolis, IN

If you're searching for prostate cancer treatment options in Indianapolis, IN, this clinical trial (NCT06084338) 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 Indianapolis research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced prostate cancer 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 prostate cancer clinical trials near you to find additional studies recruiting in your area.

Prostate Cancer Clinical Trial in Indianapolis, IN

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