PSMA-High: EBRT/ PSMA617/ ADT vs. EBRT/ ADT
A Phase II Non-blinded Randomized Study Comparing External Beam Radiotherapy (EBRT), 177Lu-PSMA-617, and Short Term Androgen Deprivation Therapy (ADT) Versus EBRT and Long Term ADT in Men With High Risk Localized Prostate Cancer
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
Not stated in the study description — ask the study team about visits and procedures.
- 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
In plain language
This study is for men with high-risk prostate cancer that is still local. It tests the drug 177Lu-PSMA-617 before and during external beam radiation, with 6 months of hormone treatment, against standard radiation with 24 months of hormone treatment. Researchers want to see if it is safe, works well, and reduces side effects from long-term hormone treatment.
This research is being done to find out if the study drug, 177Lu-PSMA-617, given before and during standard of care External Beam Radiation Therapy (EBRT) treatment, with a shorter course of Androgen Deprivation Therapy (ADT) (6 months) is (1) safe and effective compared to standard of care alone, and (2) can reduce the side effects caused by long-term (24 months) ADT in men with high risk localized prostate cancer.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be at least 18 and have a biopsy showing prostate adenocarcinoma, a type of prostate cancer.
- Have exactly one high-risk sign: stage cT3a (cancer growing just outside the prostate), Grade Group 4 or 5 (how abnormal cancer cells look), or PSA above 20 ng/mL (a blood test result).
- Have local cancer on standard scans. Some cancer in nearby pelvic lymph nodes on a PSMA-PET scan may be allowed, depending on node size on CT.
- Have a PSMA-PET scan, which looks for prostate cancer, with a tumor uptake score called SUVmax above 10.
- Be able to receive radiation and hormone treatment. Up to 45 days of earlier hormone treatment is allowed.
- Be expected to live at least 2 years and be able to care for yourself and be up for at least half the day.
- Have blood tests within the past 6 weeks showing enough blood cells and suitable kidney and liver function. Some people need an extra kidney test.
- Be able and willing to sign the consent form. If your partner could become pregnant, agree to use condoms through 6 months after the last study drug dose.
Who can't join
- Have very high-risk cancer: stage cT3b–T4 (more growth outside the prostate), primary pattern 5 (the main cell pattern is the most abnormal), 2 or 3 high-risk signs, or more than 4 biopsy samples with Grade Group 4 or 5.
- Have had prostate cancer drugs, surgery, or radiation, except for up to 45 days of hormone treatment before group assignment. Any past radioactive drug treatment or pelvic radiation also rules you out.
- Have cancer in lymph nodes or distant sites on standard scans, or distant spread on PSMA-PET. The exclusion rules count lymph nodes over 8 mm across their short side on CT as cancer spread.
- Have prostate cancer that keeps growing despite treatment to lower testosterone, a male hormone.
- Be receiving another study drug or taking part in another treatment study involving radiation, surgery, or cancer drugs.
- Have blood cell counts or organ function that do not meet study limits, or a serious health problem that could prevent taking part.
- Be unable to lie flat or tolerate the required scans or radiation. Also excluded are people who cannot safely receive pelvic radiation, including those with current or past inflammatory bowel disease.
- Refuse to sign the consent form.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * Patient must have high-risk prostate cancer (HRPC) defined by presence of exactly one high-risk feature: cT3a OR Grade Group 4 or 5 OR PSA \> 20 ng/mL. * Histologic confirmation of adenocarcinoma of the prostate. * Patient must have localized HRPC defined by conventional imaging (no N1 disease by CT or MRI). Patients with or without intra-pelvic nodal metastases by PSMA-PET may be included as long as not enlarged \>10mm short axis by conventional CT size criteria. * Patients must have PSMA-PET (68Ga-PSMA-11 or 18F-DCFPyL) with prostate tumor SUVmax \> 10. * Patient must qualify for definitive treatment of prostate cancer including EBRT as well as ADT (up to 45 days of prior ADT is allotted). * Patient must be ≥ 18 years of age. * Patient must have a life expectancy ≥ 24 months. * Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. * Adequate bone marrow reserve and organ function as demonstrated by complete blood count and chemistry panel completed within the prior 6 weeks demonstrating: 1. Platelet count of \>100 x109/L 2. White blood cell (WBC) count \> 3,000/mL 3. Neutrophil count of \> 1,500/mL 4. Hemoglobin ≥ 10 g/dL 5. Estimated glomerular filtration rate (eGFR) \> 50 mL/min based upon Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) equation. Due to safety concerns relating to renal clearance and toxicity of 177Lu-PSMA-617, patients with estimated GFR between 50 - 60 mL/min will require a 99mTc-TPA GFR test and only patients with non-obstructive pathology will be included in the study. 6. Total bilirubin \< 3 x ULN (except if confirmed history of Gilbert's disease) 7. Serum albumin \> 30 g/L 8. Aspartate aminotransferase (AST) \< 3 times the ULN * For male patients with partners of childbearing potential, agreement to use barrier contraceptive method (condom) and to continue its use for 6 months from receiving the last dose of 177Lu-PSMA-617. * Patient must have the ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Presence of a very high-risk feature: cT3b to T4 OR primary pattern 5 OR 2 to 3 high-risk features OR \>4 cores with Grade Group 4 or 5. * Any prior pharmacotherapy (with the exception of up to 45 days of ADT prior to randomization), radiation therapy, or surgery as treatment for prostate cancer. Any prior radiopharmaceutical therapy. * Any prior radiation to the pelvis. * Presence of N1 or M1 disease by conventional imaging (CT, MRI, and/or bone scan) or M1 disease by PSMA-PET (68Ga-PSMA-11 or 18F-DCFPyL). Lymph nodes with short axis \> 8 mm by CT will be considered N1 by conventional imaging. * Castration-resistant prostate cancer (CRPC). * Patient receiving any other investigational agents. * Patient is participating in a concurrent treatment protocol involving radiotherapy, surgery, or systemic anti-cancer agents. * Inadequate bone marrow reserve and organ function as detailed in 5.1.10. * Unable to lie flat during or tolerate PET/MRI, PET/CT or EBRT. * Concurrent serious medical condition that, in the opinion of the Investigator, would impair study participation. * Contraindication to receiving pelvic radiation, including history of or active inflammatory bowel disorders. * Refusal to sign informed consent.
Study sites (1)
MD
- Johns Hopkins University · Baltimore, MD 21287More trials in Baltimore