High-Risk Metachronous Oligometastatic Prostate Cancer Trial

NCT06212583 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: HP-00108148GCC 23100
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to compare the effects, good and/or bad, of using the standard of care treatment, hormonal therapy + Stereotactic Ablative Radiation (SABR) to the metastatic lesions, compared to standard of care and addition of 6-months of niraparib/abiraterone acetate combination pills and prednisone for participants with recurrent metastatic prostate cancer.

Conditions

Prostate Cancer; Oligometastatic Disease

Outcome Measures

Primary Outcomes (1)

• PSA (Prostate Specific Antigen) evaluation at the 18-month progression of both treatment arms

  PSA evaluation of progression at 18-month PSA , defined as PSA \> 0.2 ng/mL in patients initially treated with radical prostatectomy and greater than nadir + 2 ng/mL for patients initially treated with definitive radiation, with testosterone \>100 ng/dl of men who have oligometastatic castration-sensitive prostate cancer with high-risk mutations (TP53, BRCA1/2, PALB2, ATM, BRIP1, CHEK2, FANCA, RAD51B, RAD54L, MUTYH) treated with ADT + SABR MDT (6-mos) versus ADT + SABR MDT + niraparib/abiraterone acetate and prednisone (6-mos).

  18 months

Secondary Outcomes (4)

• Treatment-related adverse events of both treatment arms

  4 years

• Local control at 18 months after ADT+ SABR MDT (6-mos) vs ADT + SABR MDT + niraparib/abiraterone acetate and prednisone (6-mos) in patients with metachronous oligometastatic Castrate Specific Prostate Cancer (CSPC) disease.

  18 months

• Time to locoregional progression, time to distant progression, time to new metastasis, radiographic progression-free survival and duration of response after randomization

  4 years

• Quality-of-life measured through EPIC tool following completion of ADT+ SABR MDT (6-mos) vs ADT + SABR MDT + niraparib/abiraterone acetate and prednisone (6-mos).

  4 years

Study Arms (2)

Androgen deprivation therapy + Stereotactic ablative radiation

ACTIVE COMPARATOR

Radiation: Stereotactic ablative radiation therapy (SABR); Drug: Androgen deprivation therapy (ADT)

Androgen deprivation therapy + Stereotactic ablative radiation + niraparib/abiraterone acetate

ACTIVE COMPARATOR

Drug: niraparib/abiraterone acetate; Radiation: Stereotactic ablative radiation therapy (SABR); Drug: Androgen deprivation therapy (ADT)

Interventions

Stereotactic ablative radiation therapy (SABR) RADIATION

Both arms will receive SABR

Androgen deprivation therapy + Stereotactic ablative radiation; Androgen deprivation therapy + Stereotactic ablative radiation + niraparib/abiraterone acetate

niraparib/abiraterone acetate DRUG

Patients on Arm 2 to receive drug for 6 months

Androgen deprivation therapy + Stereotactic ablative radiation + niraparib/abiraterone acetate

Androgen deprivation therapy (ADT) DRUG

All ADT is provided as best prescribed for patient per their medical oncologist.

Androgen deprivation therapy + Stereotactic ablative radiation; Androgen deprivation therapy + Stereotactic ablative radiation + niraparib/abiraterone acetate

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years of age (or the local legal age of consent).
• Patient must have at least one and up to three asymptomatic metastatic tumor(s) of the bone, soft tissue, or extra-pelvic nodal region each \< 5 cm or \< 250 cm3 that develop within the past 6-months that are seen on imaging. A nodal lesion is defined to include nodal conglomerates located in the same nodal chain such that they can be treated in one SABR field. Up to five lesions are allowed on advanced functional imaging such as fluciclovine (Axumin), choline or Prostate Specific Membrane Antigen (PSMA) PET-CT scan.
• CT or MRI scan within 6 months of enrollment
• Bone scan within 6 months of enrollment
• Fluciclovine (Axumin), choline, or PSMA PET-CT scan within 6 months of enrollment (PET-CT scan is reasonable for study entry imaging as an alternative to CT/MRI scan and bone scan)
• Must have a high-risk pathogenic mutation (TP53, BRCA1/2, PALB2, ATM, BRIP1, CHEK2, FANCA, RAD51B, RAD54L, MUTYH) by next generation sequencing. ATM mutation enrollment will be capped at 5% of the overall population.
• Histologic confirmation of prostate adenocarcinoma (primary or metastatic tumor).
• Patient may have had prior systemic therapy and/or ADT so long as testosterone is \> 100 ng/dl prior to enrollment
• PSA \> 0.5 but \<50 at enrollment.
• Prostate Specific Antigen Doubling Time (PSADT) \< 15 months
• Baseline testosterone \> 100 ng/dl
• Patient must have a life expectancy ≥ 12 months.
• Patient must have an ECOG performance status ≤ 2.
• Adequate hematologic, renal, and hepatic function at screening defined as follows:
• Absolute neutrophil count ≥1.5 x 109/L

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• Janssen Scientific Affairs, LLC: collaborator

Study Sites (1)

University of Maryland Greenebaum Cancer Center

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

niraparib; Abiraterone Acetate; Androgen Antagonists

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 14, 2023
• First Posted: January 19, 2024
• Study Start: April 17, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)