Health TrialsbyHealthPanel

PSMA-High: EBRT/ PSMA617/ ADT vs. EBRT/ ADT

ConditionHigh-Risk Localized Prostate Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • EBRT + 6 mo ADT + 177Lu-PSMA-617

    Drug

    In Arm A, 177Lu-PSMA-617 will be given as intravenous infusion every 6 weeks, up to 4 cycles. Cycle 1 Day 1 (C1D1) of 177Lu-PSMA-617 will start at least 2 weeks after ADT, and EBRT will start at least 2 weeks after C1D1.

  • EBRT + 24 mo ADT

    Radiation

    In Arm B, EBRT will start 3-7 weeks after Day 1 of ADT.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Arm A (EBRT + 6 mo ADT + 177Lu-PSMA-617)Experimental treatment 1 intervention
Group B: Arm B (EBRT + 24 mo ADT)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Rate of testosterone recovery (TR)

The rate of testosterone recovery (TR) will be determined by the percentage of patients who recover normal T levels within 3 years after randomization.

Time frame
Post randomization up to 3 years.

Secondary outcomes

1

Biochemical disease-free survival (BC-DFS)

Measured from randomization to the time of a measured PSA value at least 2 ng/mL above nadir, and at least 25% above nadir, or death, whichever occurs first.

Time frame
From randomization up to 3 years.
2

Time-to-Next-Intervention (TTNI)

TTNI is defined as the period of time from randomization to the initiation of any additional cancer-directed therapy. In the absence of a defining event, TTNI will be censored at the date of last visit documenting absence of interventions.

Time frame
From randomization up to 3 years.
3

ADT-free survival (ADT-FS)

ADT-free survival defined as the time from randomization to the time of initiation of palliative ADT or death, whichever occurs first.

Time frame
From randomization up to 3 years.
4

Metastasis-free survival (MFS)

MFS is defined as the time from randomization to the time of detection of at least one new metastatic lesions on conventional imaging. Patients who do not develop at least one new metastasis will be censored at the time of the last disease assessment.

Time frame
From randomization up to 3 years.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead sponsor

Novartis Pharmaceuticals

Collaborator

Source ClinicalTrials.gov
Apply now