ALSO-PERFORM Study. ALternating Stereotaxic Or PElvic Radiotherapy FOR Metachronic Metastatic Prostate Cancer

NCT07863336 | Not Yet Recruiting

• 1 other identifier: 2025.0366
• Study Type: observational
• Target: 130
• Locations: 0 countries
• Sites: N/A

Brief Summary

Outcome of metastasis directed therapy

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• The primary endpoint is the number of patients (and percentage of the total) with metastases on PSMA PET/CT two years after study initiation.

  24 months

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Men with histologically confirmed prostate cancer who have undergone radical prostatectomy, have experienced biochemical (PSA) recurrence, and have lymphogenic metastases in the pelvic region on PSMA PET/CT.

You may qualify if:

• Men with histologically confirmed prostate cancer
• Men who have undergone radical prostatectomy (RP), with or without extended pelvic lymph node dissection (ePLND)
• Men with pNx or pN0 status in the ePLND specimen
• Biochemical recurrence after RP (PSA \> 0.2 ng/mL on two occasions)
• Evidence of lymphogenic metastases on staging PSMA PET/CT within the pelvis (below the aortic bifurcation)
• Life expectancy ≥ 5 years, as estimated by the treating physician

You may not qualify if:

• Previous salvage radiotherapy to the prostate bed
• Men with lymph node metastases outside the pelvis (M1a)
• Men with osseous metastases (M1b) or visceral metastases (M1c)
• Men with lymphogenic metastases and a local recurrence
• Men with inguinal metastases
• Previous treatment in the pelvic region, such as treatment of the bladder or rectum, that precludes radiotherapy to the pelvis

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead
• Accord Healthcare, Inc.: collaborator

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof Dr.

Study Record Dates

• First Submitted: October 1, 2026
• First Posted: October 7, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: October 8, 2026

Record last verified: 2026-10